STANDARD OPERATING PROCEDURESrbd.stluke.com.ph/data/File/SL-IERC SOP Manual 2013 Final v.pdf · This Revised Manual (2nded, 2013) of the St. Luke’s Institutional Ethics Review ommittee

2013 Edition

INSTITUTIONAL ETHICS

REVIEW COMMITTEE

STANDARD OPERATING PROCEDURES

SL-IERC SOP 2013 V2 | 2

INTRODUCTION to the Second Edition

The Research and Biotechnology Division (RBD) of St. Luke’s Medical Center (SLMC), from its beginnings in

1995, has recognized the need to uphold the highest standards of ethics in research. This second edition of the

Standard Operating Procedures of the Institutional Ethics Review Committee (IERC) is the culmination of several

months work to integrate the best practices in the ethical review of clinical research at the St. Luke’s. Revisions to

the First Edition were made as an offshoot to recommendations made during the survey prior to the recognition

given by the Forum for Ethics Review Committees in Asia and Western Pacific (FERCAP) in November 2012.

Incorporating international standards and regulations on which to base the ethical review process assures that

research at St. Luke’s maintains a leading edge in upholding integrity and protection of human subject rights at all

phases and in any type of clinical research It will be a valuable aid to guide and implement excellence in

institutional research, leading us towards becoming an internationally recognized academic medical center by 2020

under the leadership of SLMC President and CEO Dr. Edgardo R. Cortez.

In 2012, members of the St. Luke’s IERC and RBD support staff, together with the Vice-President of RBD,

held a series of writeshops to draft out all the required standard operating procedures employed to date. During

this time, the authors of this handbook assiduously reviewed the evolution of research ethics review from its

beginnings with the Helsinki protocols to the current global advocacy of informed subject participation and

discernment of sociocultural norms. They drew from their vast experience of training and education in Good

Clinical Practice courses through the years. Thus, this handbook is the product of a mature assessment and critical

appraisal of the best practices in the implementation of ethical review and operations of the review committee and

its support offices. This has been made possible through the unstinting support and insightful perspective of the

present IERC Chair, Dr. Prospero Ma. C. Tuano, who shared his valuable time and wisdom for the completion of this

manual.

As SLMC gears up to intensify research throughout its various sectors, we envision the IERC to perform its

review function seamlessly, with diligent adherence to the precepts of these SOPs. The goal is to raise the bar of

human subject research in SLMC and to serve as the benchmark for Ethics Review Committees in the country to

improve clinical outcomes for the benefit of our patients and all Filipinos.

FILIPINAS F. NATIVIDAD, PhD Executive Secretary St. Luke’s Institutional Ethics Review Committee

INSTITUTIONAL ETHICS REVIEW COMMITTEE

Standard Operating Procedures


I hereby submit this Revised Manual (2nd ed,2013) of the St. Luke’s-Institutional Ethics Review

Committee Standard Operating Procedures (SL-IERC SOPs) to be the official guide of the

Institutional Ethics Review Committee of St. Luke’s Medical Center.

FILIPINAS F. NATIVIDAD, PhD Executive Secretary St. Luke’s Institutional Ethics Review Committee

I hereby recommend acceptance of this Revised Manual (2nd ed, 2013) of the St. Luke’s-Institutional Ethics Review Committee Standard Operating Procedures (SL-IERC SOPs) to be the official guide of the Institutional Ethics Review Committee of St. Luke’s Medical Center.

PROSPERO MA. C. TUAŇO, MD Chairman St. Luke’s Institutional Ethics Review Committee

This Revised Manual (2nded, 2013) of the St. Luke’s Institutional Ethics Review Committee

Standard Operating Procedures (SL-IERC SOPs) is hereby officially accepted to serve as a guide

of the Institutional Ethics Review Committee of St. Luke’s Medical Center.

EDGARDO R. CORTEZ, MD, FPCS, FACS President and CEO St. Luke’s Medical Center


Standard Operating Procedures


I. SL-IERC STANDARD OPERATING PROCEDURES


Sop Table Of Contents

CHAPTER STANDARD OPERATING PROCEDURE (SOP) TITLE PAGE

1. Preparation of SOPs and Guidelines for the Institutional Ethics Review Committee (IERC)

1.1. Preparation and Amendment of SOPs……………………………………………….. 1.2. Preparation Guidelines on SOPs………………………………………………………… 1.3. Documentation Control System of SOPs…………………………………………….

8 10 12

2. SOPs of the Institutional Ethics Review Committee (IERC) 2.1. Composition, Duties and Responsibilities of the SLMC QC & GC

IERC..…………………………………………………………………………………………………. 2.2. Confidentiality Agreements and Conflict of Interest Disclosure…………. 2.3. Training of IERC Members and Staff……….……………………………………….. 2.4. Resource Persons……………………..……………………..……………………………… 2.5. Honorarium of IERC and Secretariat………………………………………………….. 2.6. Appointment, Duties and Responsibilities of Executive Secretary and IERC Secretariat …………………………….………………………………………………..

15 19 20 22 23

24

3. Procedures for Initial Protocol Submissions and Ethical Review

3.1. Initial Protocol Submissions……………………………………………………………… 3.2. Initial Submission of Application through the Web portal…………..……. 3.3. Preliminary Review By IERC Members Prior to Presentation……………. 3.4. Full Board Review of Protocols…………………………………………………………… 3.5. Expedited Review……………………………………………………………………………….

28 30 32 34 36

4. Continuing Review and Monitoring of Protocols 4.1. Review of Protocols That Require Major Revisions

after Presentation……………………………………………………………………………. 4.2. Review of Protocol Amendments……………………………………………………. 4.3. Progress Reports for Continuing Review…..…………………………………….. 4.4. Assessment of Serious Adverse Events…………………………………………….. 4.5. Early Termination of Clinical Trials Due to Protocol

Deviations/Violations……………………………………………………………………… 4.6. Site Visit………………………………………………………………………………………..…

40 42 44 46

49 51

5. Administrative Procedures 5.1. Preparation of Notice of Meeting and Agenda………………………………… 5.2. Preparation and Distribution of Minutes of Meetings……………………… 5.3. Emergency/Special Meetings………………………………………………………….. 5.4. Preparation for a Regular Meeting………………………………………………….. 5.5. Conduct of a IERC Meeting……..………………………………………………………. 5.6. Management of Communications………………………………………………….. 5.7. Management of Administrative Files, Logbooks and Forms……………..

54 57 59 61 63 65 66


II. LIST OF SL-IERC FORMS

III. GLOSSARY……………………………………………………………..…………………………………………………..……

IV. REFERENCES……………………………………………………………………………………………………………….

FORM DESCRIPTION FORM #

1. Agreement on Confidentiality and Conflict of Interest Form SL-IERC FORM#01A

2. Agreement on Confidentiality and Conflict of Interest Form (for Preliminary Reviewer)

SL-IERC FORM#01B

3. Initial Protocol Review Submission Form SL-IERC FORM#02

4. Initial Protocol Review Submission Acknowledgment Form SL-IERC FORM#03

5. CT Tracking Form SL-IERC FORM#04

6. Technical Review Form SL-IERC FORM#05A

7. Ethics Review Form SL-IERC FORM#05B

8. Notice of Meeting SL-IERC FORM#06A

9. Notice of Emergency Meeting SL-IERC FORM#06B

10. Invitation to Present SL-IERC FORM #08

11. IERC Attendance Sheet SL-IERC FORM #09A

12. Attendance Sheet for Presentors SL-IERC FORM #09B

13. Principal Investigator’s Responsibilities SL-IERC FORM #10

14. Notice of Action SL-IERC FORM #12A

15. IERC Composition SL-IERC FORM #12B

16. Ethical Clearance SL-IERC FORM#13A

17. Request for Ethical Clearance Renewal SL-IERC FORM#13B

18. Ethical Clearance Renewal Form SL-IERC FORM#13C

19. SAE Form SL-IERC FORM#14A

20. SAE Tracking Form SL-IERC FORM#14B

21. Protocol Deviation/Violation SL-IERC FORM#15

22. Continuing Review Report Form SL-IERC FORM#16

23. Agenda Template SL-IERC FORM#17

24. Minutes of the Meeting Template SL-IERC FORM#18

25. Final Report Form SL-IERC FORM#19


Document History

REVIEW REVISION REASON FOR

REVISION REVIEWED BY APPROVED BY REVISED EFFECTIVE

DATE NO. DATE NONE NO.

1 10-2012 1

For compliance with FERCAP

surveyors suggestions

FILIPINAS F. NATIVIDAD, PhD

Executive Secretary

IERC Chair April 2013


Preparation of Standard Operating Procedures (SOPs) and Guidelines for the Institutional Ethics Review

Committee(IERC)


CHAPTER 1

1. Preparation of Standard Operating Procedures (SOPs) and Guidelines for the Institutional Ethics Review Committee (IERC)

1.1. Preparation and Amendment of SOPs 1.2. Preparation Guidelines on SOPs 1.3. Documentation Control System of SOPs


REVIEW COMMITTEE


1. PURPOSE To describe the manner in which an SOP shall be formulated, reviewed, approved, distributed, and amended.

2. SCOPE From identification of the SOP to be formulated or amended, writing of the SOP, to the review and approval process, implementation and archiving.

3. FLOW CHART

PROCESS PERSON/S RESPONSIBLE

Executive Secretary/IERC SOP team

IERC SOP team

and Secretariat

IERC Chair and Members

President and CEO

Secretariat IERC Chair and Members Secretariat

4. PROCEDURE 4.1. Identification of the SOP to be formulated or amended

4.1.1. The Executive Secretary through the IERC shall propose the formulation of a new SOP or the amendment of an existing SOP.

4.1.2. The proposal shall include the rationale for the new SOP or for the amendment and shall be discussed as part of the Agenda of an IERC regular meeting.

4.1.3. The decision on the proposal shall be made through a consensus of the IERC.

4.2. Writing, Formulation, Formatting and Approval of the SOP 4.2.1. The Executive Secretary and the IERC SOP Team shall be responsible for the writing or

amending the SOP. 4.2.2. The final draft of the new/amended SOP shall be included in the Agenda of the IERC

regular meeting and shall be formally approved by a consensus. 4.2.3. The President and CEO shall sign and date the approved SOP upon recommendation of

the IERC Chair and the Executive Secretary

INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE

Preparation and Amendment of SOPs

SL-IERC SOP # 1.1 Effective Date: April 2013

Identification of SOP to be written

Formatting of SOP

Review and Amending of SOP

Approval

Implementation


5. ARCHIVING/FILING SYSTEM

5.1. The signed SOP shall be assigned a Control SOP Number and shall be incorporated in the SOP file.

5.2. The Secretariat shall keep the original signed and dated controlled copy as part of the Updated SOP Manual.

5.3. The Secretariat shall maintain the revision history for all amended SOPs, including the Revision date and Version Number.

6. EFFECTIVITY and IMPLEMENTATION 6.1. The new or amended SOP shall be effective immediately upon the recommendation of the

IERC, Chair and approval of the President and CEO. 6.2. The IERC Chair and Members and Secretariat shall be responsible for the implementation of

the approved new or amended SOP. 6.3. The Secretariat shall provide uncontrolled copies to IERC members and other authorized

personnel.

---Nothing Follows---


STANDARD OPERATING PROCEDURE Preparation and Amendment of SOPs



1. PURPOSE To describe the guidelines and procedures in the preparation and writing of the SOP of the St. Luke’s Institutional Ethics Review Committee. These guidelines shall serve as reference in the preparation and writing of SOP for the St. Luke’s Institutional Ethics Review Committee (SL-IERC).

2. SCOPE From the description of the format and contents to the numbering of the SOP.

3. FLOW CHART

PROCESS RESPONSIBILITY

Executive Secretary

Secretariat

Executive Secretary IERC SOP team and IERC Chair and members

4. PROCEDURE 4.1. The IERC shall follow a standard format for a written SOP. Each page shall have the

following:

Logo of SLMC in the upper left portion

INSITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCECURE in bold upper case letters as header at the center

Title of the specific SOP below the header

SOP number in the upper right portion

Effectivity date below the SOP number

Pagination and Revision history as Footer

4.2. The standard contents of the main text of the SOP shall have the following parts:

Purpose

Scope

Flow Chart

Procedure

Standardization of the SOP format,

contents and signatories

Numbering of SOP

Implementation


Preparation Guidelines on SOPs



5. Description of Contents

5.1.1. Purpose- This states the aim of the SOP 5.1.2. Scope- This shows the initial activity involved until the entire procedure ends 5.1.3. Flow Chart -This illustrates the chronological order of the various steps involved in the

procedure, including the person or groups of persons who are responsible for each step. 5.1.4. Procedure -This is a detailed description of the various steps outlined in the Flow Chart. 5.1.5. Optional parts -References and attachments shall be included when appropriate.

5.2. Signatories of SOPs

5.2.1. The signatories of the SOPs shall include the following:

Prepared and Recommended by the Executive Secretary

Approved by the IERC Chair

5.3. Numbering of SOPs 5.3.1. All SOP shall be identified by a document code that contains letters and numbers, i.e. SL-

IERC SOP #XX 5.3.2. Only the final version of an SOP shall be given a document code. 5.3.3. The original version of an SOP shall have the following in the footnote: SL-IERC SOP

Year- v1 5.3.4. When an SOP undergoes revision, it retains the same document code, but the footnote

shall indicate the year of revision and version number shall as follows: Year-v2 5.3.5. A revised SOP shall have a new effectivity date

---Nothing Follows ---


Preparation Guidelines on SOPs



1. PURPOSE

To establish a system to properly maintain and control IERC SOPs

2. SCOPE From stamping of controlled copies to distribution of uncontrolled copies .

3. FLOW CHART


Executive Secretary /IERC Secretariat Assigned Member of the IERC Secretariat Assigned Member of the IERC Secretariat

4. PROCEDURE 4.1. The Executive Secretary and members of the Secretariat shall establish a system of filing,

retrieving and releasing of SOP copies. 4.1.1. The IERC office shall be the central repository of all SL IERC SOPs. 4.1.2. The IERC Secretariat shall stamp an original signed SOP as “CONTROLLED COPY”. 4.1.3. The IERC Secretariat shall ensure that any SOP that is reproduced and circulated is

stamped as “UNCONTROLLED COPY”. 4.2. The IERC Secretariat shall be the control center and repository for all SL IERC SOPs.


Establishment of a system of filing/

retrieving/releasing of SOP copies

Stamping of original signed copies

as “CONTROLLED COPIES”

Distribution of

UNCONTROLLED COPIES


Documentation Control System for SOPs



Document History

REVIEW REVISION REASON FOR REVISION

REVIEWED BY APPROVED BY REVISED EFFECTIVE DATE NO. DATE NONE NO.

1

10-2012

1

Compliance with

suggestions of FERCAP

surveyors

Filipinas F. Natividad, PhD

Executive Secretary

IERC Chair

April 2013


STANDARD OPERATING PROCEDURE SOPs of the Institutional Ethics Review Committee (IERC)



REVIEW COMMITTEE

2. SOPs of the Institutional Ethics Review Committee (IERC)

2.1. Composition, Duties and Responsibilities of the IERC 2.2. Confidentiality Agreements and Conflict of Interest

Disclosure 2.3. Training of IERC Members and Personnel 2.4. Selection of Resource Persons 2.5. Honorarium of IERC Members and Secretariat 2.6. Composition, Duties and Responsibilities of IERC

Executive Secretary and IERC Secretariat Attachment: St. Luke’s Medical Center Organizational Chart

CHAPTER 2


1. PURPOSE

To ensure a standard process of selection of members, the criteria for membership, the organizational structure and the duties and responsibilities of the Chair and members since the Ethics Committee is authorized to review various types of protocols submitted to SLMC-QC/GC.

2. SCOPE

From selection of membership to specifying duties and responsibilities of SLMC-QC/GC IERC.

3. FLOW CHART


VP for RBD

President and CEO of SLMC

Executive Secretary

IERC Chair, VP of RBD, Executive Secretary and President and CEO

4. PROCEDURE

4.1. Method of Selection and Terms of Reference

4.1.1. The VP of RBD shall recommend the constitution for SL-IERC. 4.1.2. The President and CEO shall officially appoint the Chair, Vice-Chair and Executive

Secretary and members of the IERC. 4.1.3. Members shall be appointed for a term of 2 years. 4.1.4. There shall be no limit as to the maximum number of terms a member is reappointed.


STANDARD OPERATING PROCEDURE Composition, Duties and Responsibilities of the

SLMC QC and GC Institutional Ethics Review Committee


Appointments and Terms of appointments and disqualification of

the IERC members

Description of the Duties and Responsibilities of the IERC Chair and

Executive Secretary and members

Resignation, Disqualification and Replacement of an IERC member

Recommendation for constitution of IERC membership


4.2. Membership of the IERC shall be multidisciplinary and multi-sectoral with the following minimum composition in accordance with the guidelines set by the Philippine Health Research Ethics Board and the requirements listed on the manual Reviewing Clinical Trials: A Guide for the Ethics Committee

Two physicians from the institution with experience in medical research.

A member of a religious community

A lawyer, who represents concerns of the community

A basic medical research scientist

A layperson independent from the institution and with no scientific expertise

A member independent from the institution with scientific expertise

One clinician who is experienced in working with vulnerable participants (e.g. children and those persons incapable of giving consent)

4.3. Both male and female genders shall be represented in the IERC

4.4. The Vice President for RBD shall be a regular member of IERC.

4.5. The President and CEO shall appoint an Executive Secretary to head and oversee the IERC Secretariat which shall also be a voting member of the committee. Refer to SOP 2.6 for the Duties and Responsibilities of an Executive Secretary.

4.6. The President and CEO may appoint additional members to the IERC in conformity with ICH-GCP regulations.

5. ROLES AND RESPONSIBILITIES OF THE IERC

5.1. The IERC shall review clinical trials/studies on drugs, devices and diagnostics, herbal medicine research, complementary and alternative medicine research as well as other researches that involve human participants including research on identifiable human material or identifiable data.

5.2. The IERC shall review essential documents of clinical trials and researches involving human subjects (i.e. all Phases of Clinical Trials including Investigator-Initiated, Observational, Registry and Post Marketing Surveillance Studies) submitted to IERC to safeguard the rights, dignity and welfare of human participants.

5.3. The IERC shall ensure that clinical trials and researches shall be conducted in accordance with Philippine laws and National Ethical Guidelines for Health Research 2011 by Philippine National Health Research System (PNHRS), International Conference on Harmonization (ICH) for Good Clinical Practice and Association for the Accreditation of Human Research Protection Programs, Inc.(Please see ICH GCP Guidelines and Philippine National Ethical Guidelines for Health Research 2011 handbook and Reviewing Clinical Trials: A guide for Ethics Committees 2010 as reference.)

5.4. The IERC shall recommend the approval of clinical trial/study, investigator-initiated researches, RBD-funded researches if:

5.4.1. all ethical issues have been addressed

5.4.2. the protocol is compliant with Good Clinical Practice and has no ethical issue after the presentation

5.4.3. the Protocol has been revised in accordance with the Notice of Action issued by the IERC Secretariat to the Principal Investigator and the IERC has made a Continuing Review of the response. Please refer to Quality Procedures on the Ethical Review Clinical Trial Protocols and SL-IERC SOP#4.1 Review of Protocols that Require Major Revisions.’

INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Composition, Duties and Responsibilities of the




5.5. The IERC shall assemble for meetings on the following occasions.

Regularly every month commonly agreed by the IERC members

Emergency meetings convened by the IERC chair

Special assignments designated by the PHREB and St. Luke’s Medical Center President & CEO.

5.6. It shall issue the Ethical Clearance to indicate IERC approval following the review of the Protocol.

5.6.1. The Ethical Clearance shall indicate the dates of review, approval, validity and responsibilities of the Principal Investigator.

5.6.2. The Ethical Clearance shall be valid for 2 years according to trial site (e.g. St. Luke’s Medical Center-Quezon City and Global City and other institutions).

5.6.3. Extension of the Ethical Clearance shall be granted upon:

written request of the Principal Investigator

submission of progress report

favorable evaluation of the progress report.

payment of extension fee

5.7. It shall evaluate reports on serious adverse events/ unexpected adverse events and submit reports to the Medical Director-QC or Medical Director-GC. (Please refer to policy on Monitoring of Clinical Safety of Investigational Drugs).

5.8. It shall perform continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects or at least once a year (based on the IERC review approval date) using the IERC Continuing Review Report Form issued by the IERC Secretariat. (Refer to SOP on Continuing Review Procedures)

5.9. It shall identify a resource person or a known expert to provide additional information about a study when necessary.

6. RESPONSIBILITIES OF THE IERC MEMBER

Each Member of the IERC shall have the following responsibilities:

Attend IERC meetings regularly and participate in the review and evaluation of research protocols and other related requests as part of a full or expedited review.

Participate in the evaluation of approved protocols through the continuing review process.

Participate in the review of progress and final reports, amendments presented during IERC meetings, and adverse events

Make himself familiar with the SOPs of the SL-IERC

Attend seminars, workshops and conferences in research ethics to enhance his competencies as member of the IERC

Obtain GCP certificate which shall remain valid for 3 years.

Submit an updated CV at the start of each new appointment

Declare any conflict of Interest on any of the research protocols submitted for review.

Maintain confidentiality of the documents and deliberations of the IERC meetings.

INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE Composition, Duties and Responsibilities of the


SL-IERCSOP # 2.1 Effective Date: April 2013


7. RESPONSIBLITIES OF THE IERC CHAIR

The IERC Chair shall have the following responsibilities:

Finalize the agenda and preside in all IERC meetings.

Conduct a preliminary review of all protocols and decide on the nature of review

Ensure that a final decision on all protocols reviewed is made and break a tie whenever a deadlock in IERC voting occurs

Sign the Ethical Clearance Form

Sign the following communications: Notice of Meetings, Notice of Action to Principal Investigators and Sponsors

Represent St. Luke’s Medical Center in ethics-related symposia or meetings that require institutional participation

Ensure that appropriate decisions/actions are made by the IERC on issues that include but are not limited to research participants complaints, findings of non-compliance during an FDA audit, loss of records or study drugs, higher than expected occurrences of adverse events, unexpected adverse events that are at least possibly related to the study, drug accountability problems, unanticipated change in Principal Investigator, etc.

Submit annual reports on the accomplishments of the IERC to PHREB

Communicate decisions of the IERC to research proponents.

8. Responsibilities of the Vice-Chair

The Vice-Chair shall have the authority to perform all the duties of the Chair when the latter is unavailable or unable to perform them

He shall perform such other tasks as delegated by the Chair 9. Resignation, Disqualification and Replacement of Members

9.1. An IERC member may resign from the committee at any time during his term through an official letter addressed to the Chair.

9.2. An IERC member may be recommended by the Chair for disqualification for any of the following reasons:

9.2.1. Failure to attend 3 consecutive meetings of the IERC without any valid reason

9.2.2. Failure to disclose Conflict of Interest

9.2.3. Violation of the Confidentiality Rule

9.3. Replacement of the resigned ERC member shall be made by the President/CEO, upon recommendation of the VP for RBD (SOP 2.1-4.1.1)



STANDARD OPERATING PROCEDURE Composition, Duties and Responsibilities of the




1. PURPOSE To ensure that the members of the Institutional Ethics Review Committee (IERC) read, understand, accept, sign and date a Confidentiality Form and a Conflict of Interest Disclosure.

2. SCOPE From providing the forms to filing of signed and dated documents

3. FLOW CHART


Secretariat

IERC members Secretariat

4. PROCEDURE:

4.1. The Secretariat shall provide each IERC member a copy of the Agreement on Confidentiality

and Conflict of Interest. (Refer to SL-IERC Form # 01A)

4.2. IERC members read the forms and affix their signature, indicating the date of signing.

4.3. The Secretariat files the signed documents in the respective Reference Binders of each IERC

member and the Master File.



STANDARD OPERATING PROCEDURE Confidentiality Agreement and

Disclosure of Conflict of Interest

SL-IERC SOP # 2.2

Effective Date:

April 2013

Provision of forms for Confidentiality Agreement and Disclosure of Conflict of

Interest to IERC members

Reading/signing/dating of 2 copies of the forms

Filing of signed documents to Member’s Referendum Binder and providing copies

to respective member


1. PURPOSE

To ensure that members of the IERC and Secretariat team regularly attend seminars/training/ workshops/conferences to maintain and enhance their competence and skills through an updated knowledge of research ethics and guidelines.

2. SCOPE

From identification of to attendance in seminars/training/workshops/conferences on ethics, ethics review committees, and other related topics

3. FLOW CHART


Secretariat

IERC Chair/

Executive Secretary


Training of IERC Members and Staff


Identifying availability and schedule of seminars/trainings/workshops/conferences

Approval to provide funding for international

training/workshop/conferences

Filing of Training Certificates

Identifying personnel to attend seminars/training/workshops/conferences

IERC members and Secretariat

Approval to provide funding for local training/workshop/conferences

VP for RBD

President/CEO

Secretariat

Attendance in seminars/training/workshops/

conferences

International

seminar/training/workshop

s?

No Yes

Request for financial support


3.1. The Secretariat shall regularly obtain information on the availability and schedule of training courses, workshops, and conferences on ethics, ethics review committees, and other related topics.

3.2. The IERC Chair and Executive Secretary shall identify members of the IERC and the Secretariat team who will attend seminars/training/workshops and conferences.

3.2.1. For attendance in local venues, the Vice President for RBD shall make the official approval.

3.2.2. For regional and international venues, the Vice President for RBD shall make the appropriate request for financial support and approval by the President/CEO.

3.3. IERC members and Secretariat Team who attend any seminars/training/workshops and Conferences shall submit their certificate or proof of attendance for filing by the Secretariat.

---Nothings Follows---


STANDARD OPERATING PROCEDURE Training of IERC Members and Staff



1. PURPOSE To describe the procedure for getting the services of an expert to serve as Resource Person on matters outside the expertise of members of the Institutional Ethics Review Committee (IERC)

2. SCOPE

From identifying the need and the expert to providing compensation for the Resource Person

3. FLOW CHART


IERC

IERC

Resource Person/VP for RBD

Resource person

Accounting Dept./Secretariat

4. PROCEDURE

4.1. When deemed necessary, the IERC may invite an expert to serve as resource person for the review of a specific protocol.

4.2. The VP of RBD shall have the prerogative to appoint the resource person as an independent consultant upon recommendation of the IERC/IERC Chair.

4.3. The resource person shall sign a Service Agreement upon his/her appointment.

4.4. The resource person shall participate in the review of a specific protocol and give his/her inputs on specific issues related to his expertise.

4.5. The resource person shall not have any voting rights.

4.6. The resource person shall receive an honorarium, the amount of which shall be determined by the VP for RBD, for his/her services rendered.

4.7. Secretariat shall request Accounting Department to prepare honorarium for Resource Persons.

4.8. Secretariat gives the honorarium to Resource Person.



Resource Persons


Determination of need for a

Resource Person

Identification of expert and invitation to serve as Resource

Person

Signing of Service Agreement

Participation in appropriate

Meeting

Payment of honorarium


1. PURPOSE

To ensure that the members of the Institutional Ethics Review Committee (IERC) and Secretariat are granted honoraria for their work in the committee.

2. SCOPE

From recommendation for grant of honorarium for, to acknowledgment receipt of honorarium by the members of the Institutional Ethics Review Committee (IERC)and Secretariat.

3. FLOW CHART


VP of RBD

President and CEO

Secretariat

Accounting Department

IERC/Secretariat

4. PROCEDURE

4.1. The Vice-President for Research and Biotechnology Division shall recommend to the President/CEO the granting of honorarium to the IERC and Secretariat for their work in the committee. The honorarium shall cover an amount for review of protocols, for attendance and participation in meetings and other IERC activities and a year-end bonus

4.2. The VP for RBD shall recommend increase in the honorarium depending on the workload.

4.3. The Secretariat shall prepare request for honorarium forwarded to SLMC Accounting Department.

4.4. The IERC members and Secretariat shall sign a voucher upon receipt of honorarium check from the Accounting Department.



STANDARD OPERATING PROCEDURE Honorarium of IERC and Secretariat


Recommendation for grant of honoraria of IERC members and

Secretariat

Approval/Disapproval

Dispensation of honorarium

Acknowledgment of honorarium

Request for preparation of honorarium


1. PURPOSE

To describe the appointment of the Executive Secretary and IERC Secretariat and delineate their duties and responsibilities.

2. SCOPE

From the appointment and identification of the Executive Secretary and staff of IERC Secretariat to the delineation of their duties and responsibilities.

3. FLOW CHART


Executive Secretary

Executive Secretary

4. PROCEDURE

The IERC Secretariat and Administrative Support Staff

4.1. An Executive Secretary shall be appointed by the President and CEO to head and oversee the IERC Secretariat.

4.1.1. The Executive Secretary shall be a member of the IERC and has the following duties:

Acts as voting member of the IERC (transfer to SOP 2.1)

Generally conducts the business of the IERC i.e. supervises the work of the secretariat.

Receives and acknowledges all correspondence with the Principal Investigator

Does initial review to determine type of review and submits recommendation to IERC Chair

Identifies and assigns an expert reviewer/resource person for a specific protocol

Convenes meetings as instructed by Chair when necessary

Arranges regular EC meetings and documents the proceedings and resolution of all meetings(transfer to SOP 2.1)

Documents the start of each meeting the existence of any conflicts of interest (transfer to SOP 2.1)

Clarifies to the Principal Investigators ethical problems that may arise from a clinical trial/research and presents the ethical problem for IERC review

Prepares and sends memorandum to all Principal Investigators (whether sponsored-study, investigator-initiated or RBD-funded) to comply with the IERC Continuing Review Report.


STANDARD OPERATING PROCEDURE Appointment, Duties and Responsibilities

of the Executive Secretary and IERC Secretariat


Identification of Staff and Administrative Staff for the

IERC Secretariat

Delegation of duties and

responsibilities

Executive Secretary Appointed President and CEO


4.2. The Research and Biotechnology Division staff assigned to the IERC Secretariat shall be the administrative support staff of the IERC – re-word/re-write

4.2.1. Responsibilities of the Secretariat

Receives, documents, and records all applications for protocol review

Prepares the tracking form and assigns a tracking number for all complete

protocols received/as soon as initial submission is complete

Forwards submitted protocol to Executive Secretary for pre-determination of type of Review ERC Chair for initial review in order to determine type of review process

Prepares agenda and Notices of Meetings of ERC

Collates all essential documents for ERC meetings and distributes these to ERC members

Prepares and distributes communications to, and coordinates with, all Principal Investigators regarding schedule of protocol presentation

Takes and prepares Minutes of ERC Meetings

Keeps and maintains archives of the following: Dossier of each reviewed protocol, minutes of meetings, file of ERC members

Answers queries from Clinical Research Organizations (CROs), Sponsors, and Investigators on matters relevant to the functions/activities/schedules etc. of the ERC

Maintains confidentiality of all documents of the ERC

Prepares reports and other matters to be presented at ERC meetings

Requests the use and assures the availability, of venue for ERC meetings

Prepares request for food and beverages to be served during ERC meetings

Assures functionality of audiovisual equipment for presentors

Prepares requests for honorarium of ERC members

Arrange transport service for ERC members not affiliated with SLMC

Performs other functions as requested by ERC members



STANDARD OPERATING PROCEDURE Appointment, Duties and Responsibilities

of the Executive Secretary and IERC Secretariat



Document History


Procedures for Initial Protocol Submissions and Ethical Review



1

10-2012

1

Compliance with

suggestions of FERCAP

surveyors


Executive Secretary

IERC Chair

April 2013


CHAPTER 3


REVIEW COMMITTEE

Procedures for Initial Protocol Submissions and Ethical Review

3.1. Initial Protocol Submissions 3.2. Initial Submission of Application through the

Center for Clinical Trials (CCT) Web portal 3.3. Preliminary Review By IERC Members Prior to

Presentation 3.4. Full Board Review of Protocols 3.5. Expedited Review


1. PURPOSE To ensure a standard process of submission of protocols for review, particularly the responsibilities and procedures for initial review.

2. SCOPE

From submission of protocol dossier up to the classification of the type of review.

3. FLOWCHART


Secretariat

Secretariat

Secretariat

Executive Secretary/IERC Chair


Initial Protocol Submissions


Receipt of Documents for review with the accomplished CT Initial Protocol

Submission Form

Evaluation for Completeness of submitted dossier using CT

Initial Protocol Review Acknowledgement Form

submittedDocument

If not complete, information sent

to concerned Principal

Investigator

If complete, acceptance and assignment of a

EC Reference Number

Full Review?

Expedited Review

Secretariat will send

Protocol to assigned IERC

members

Secretariat informed

Principal Investigator

Protocol that he/she will

present to IERC

Initial Review to determine

type of review

No Yes


1. PROCEDURE 1.1. Receipt of documents for review.

1.1.1. The Secretariat receives the protocol dossier at the IERC office which includes the following:

Accomplished Initial Protocol Submission Form (Refer to SL-IERC Form#02)

Letter of intent addressed to IERB Chair

10 copies of the following (if applicable): Protocol with the following attachments

- Informed Consent Form (English and Tagalog) - Case Report Forms - Investigator’s Brochure

1 copy each of the following (If applicable): Pharmacokinetics Subject Worksheets/Patient Diary/Alert Cards (English and Tagalog versions) Questionnaire (English and Tagalog Versions)

Philippine Food and Drug Administration Approval

Certificate of Product Registration in the Philippines for Post Marketing

Surveillance Studies(PMSS)

Curriculum Vitae of Investigators

GCP Certificates of Investigators

Certificate of Insurance 1.1.2. The Secretariat logs the protocol submission using the CT Tracking Form.

(Refer to SL-IERC Form #04) 1.2. Evaluation of completeness of the dossier based on the IERC Initial Protocol Review

Acknowledgement Form. (Refer to SL-IERC Form #03)

If the dossier is incomplete, Secretariat communicates with the concerned PI through phone or email.

This is logged in the appropriate logbook. For protocols only awaiting approval from the FDA, the IERC can conduct a

parallel review; however, the issuance of Ethical Clearance shall be withheld until completion of said requirement.

If the dossier is complete, the Secretariat assigns anEC Reference Number to the protocol. EC Reference Number is composed of the letters, C T , last 2 digits of the year; running number starting with 1 (eg. CT 11 001) 11is for 2011; 001 is First protocol received for the year, etc.

1.3. Classification of type of review

1.3.1. The Secretariat shall inform the Executive Secretary of the receipt of a new protocol. 1.3.2. The IERC Chair and the Executive Secretary shall determine if the protocol is for Full

Board review or for Expedited Review. 1.3.3. The Secretariat shall prepare the appropriate communication as to the type of review.

1.3.3.1. If protocol is for full review, the Secretariat shall inform the Principal

Investigator the type of review to be done and schedule the presentation of the protocol in a regular IERC meeting. (Refer to SL-IERC SOP#3.3)

1.3.3.2. If protocol is for expedited review, the Secretariat shall send a protocol to IERC members assigned to review.



STANDARD OPERATING PROCEDURE Initial Protocol Submissions



1. PURPOSE

To establish a documented procedure for assessing protocols submitted through the web portal 2. SCOPE

From the submission of application for protocol review via the web portal to the classification of type of review

3. FLOWCHART


Secretariat

Electronic Reply from web

portal

Secretariat


Secretariat

Secretariat



STANDARD OPERATING PROCEDURE Initial Submission of Application

through the Web portal


Daily checking of web portal

applications

Automatic reply generated

Submission of hard copies of

documents for review

Assessment of completeness of submission using CCT Initial Review

Submission Form documents

Assignment of a EC Reference Number

Acknowledgment of receipt of Application

Classification of type of review


4. PROCEDURE

4.1. Application through the web portal 4.1.1. Principal Investigator logs in to the IERC web portal on the SLMC Website and fills up

the Initial Protocol Submission Form. (Refer to SL-IERC Form#02) 4.1.2. The completed Initial Protocol Submission Form is submitted electronically 4.1.3. An automatic acknowledgement is generated by the web portal upon submission of

the on-line application. 4.1.4. The Secretariat shall inform the applicant through email to submit required

documents in order to complete his on-line application. (Refer to SL-IERC SOP #3.1)

4.2. Submission of requirements for application 4.2.1. The applicant shall submit hard copies of the required documents to complete his

application to the IERC office either by hand carry or courier. 4.2.2. The applicant may check the status of his application in the webportal. 4.2.3. The Secretariat shall assess the completeness of submitted documents using Initial

Protocol Submission Form. 4.2.4. The Secretariat assigns an EC Reference Number. If submitted protocol is

complete/upon completion of protocol and required documents

4.3. Classification of type of review (Refer to SL-IERC SOP# 3.1)



STANDARD OPERATING PROCEDURE Initial Submission of Application

through the Web portal



1. PURPOSE To establish a documented procedure for the preliminary ethical review of clinical trial protocols prior to an IERC meeting.

2. SCOPE

From the distribution of protocol dossier to each IERC members ton risk assessment.

3. FLOW CHART


Secretariat

IERC members

IERC members

4. PROCEDURE

4.1. The Secretariat shall provide each member of the IERC, one week in advance, copies of all clinical trials/research protocols scheduled for presentation in a regular or special meeting of the ERC

4.2. Each member of the IERC shall make his/her own individual review by using the Ethics Review Forms (Refer to SL-IERC Form#05B) 4.2.1. Evaluate or Comment of the Technical aspects 4.2.2. Evaluate the Informed Consent Form 4.2.3. Comment on the Assent Form if the protocol includes children as participants 4.2.4. Make a Risk Assessment by checking the appropriate box as follows:

High Risk - if study can lead to an unexpected/unplanned loss of life, or permanent impairment of quality of life, or may lead to serious legal action against Principal Investigators and/or institution

-The study risk is greater than a moderate risk study due to the increased probability for generating serious adverse events. There is a high probability of an event that is serious and prolonged or permanent occurring as a result of study participation*


STANDARD OPERATING PROCEDURE Preliminary Review By IERC Members

Prior To Protocol Presentation


Distribution of Protocol Dossier

to IERC members

Individual Review

Risk Assessment


Medium Risk /Moderate Risk- if the result requires notification to ethics committee Moderate Risk- Risks are recognized as being greater than minimal, but are not considered high. There is a medium to high probability of a moderate-severity event occurring as a result of study participation (e.g., reversible worsening of a non-fatal disease such as seasonal allergy while receiving placebo or pneumonia from a bronchoscopy), but there is adequate surveillance and protections to identify adverse events promptly and to minimize their effects. *

Low risk /Minimal Risk - if the consequences can be dealt with by routine operations Minimal risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.( 45 CFR 46.102) Note: University of Kentucky Minimal risk definition


* Protocol Risk assessment and Monitoring Guidelines of the North Carolina Translational and Clinical Sciences Institute


STANDARD OPERATING PROCEDURE Preliminary Review By IERC Members

Prior To Protocol Presentation



1. PURPOSE To describe the procedure for full review of submitted clinical trial protocols/research proposals

2. SCOPE From presentation of the protocol /proposal in a regular IERC meeting to filing of Notice of Action in appropriate folder

3. FLOWCHART


4. PROCEDURE

4.1. Presentation of Protocol/Proposal

4.1.1. The Principal Investigator/Proponent shall present his protocol/proposal before the IERC en banc.

4.1.2. The Principal Investigator/Proponent shall discuss the 7 basic factors for ethical review as follows:

Social or Scientific Value

Fair Subject Selection

Favorable Risk-Benefit Ratio

Independent Review

Informed Consent

Respect for Potential and Enrolled Subjects

4.1.3. At any time during the presentation, the members of the IERC may interrupt and ask a question.

4.1.4. The interpolation can still proceed after the presentation. 4.1.5. The IERC Chair or Executive Secretary shall present the issues raised by those who are

absent, if these have not been previously resolved


STANDARD OPERATING PROCEDURE Full-Board Review of Protocols


Presentation of Protocol/Proposal

Interpolation

Evaluation of Protocol/Proposal

Deliberation

Decision by consensus

Notice of Action


IERC

IERC

IERC

Secretariat/Principal

Investigator/Proponent

IERC


4.2. Evaluation of the Protocol

4.2.1. The members of the IERC shall make their final evaluation immediately after the interpolation. They shall complete, date and sign the Ethics Review Form (SL-IERC Form#05B) accordingly.

4.2.2. The IERC Chair shall ask each member to present/recite his/her comments. After a thorough deliberation, a consensus is reached.

4.2.3. The IERC Chair shall summarize the issues and recommendations on the protocol. These include the following:

comments on the evaluation by the IERC members

deliberation that ensued after the presentation

4.3. The decision of the committee shall be made by consensus as follows:

Approved - protocol is approved since risks to subjects are minimal and reasonable in relation to anticipated benefits. Selection of subjects is equitable, informed consent will be asked from prospective subjects or subject’s legal representative and will be appropriately documented. Research plan makes adequate provisions for monitoring data collected to ensure safety of subjects and protect the privacy of subjects and confidentiality of data. Additional safeguards have been included to protect welfare of vulnerable subjects.

Minor Revision – protocol is found to have some minor issues that need to be addressed as recommended by the committee and upon submission of amendments Executive Secretary will present revisions to the ERC for approval.

Major Revision – protocol is found to have major issues and there is insufficient information that can help committee to make a decision. Upon completion of issues/documents, protocol will be presented again to the IERC by Principal Investigator.

Disapproved - protocol is ethically unacceptable. However an appeal can be made by the Principal Investigator. (Based on WHO- Casebook on Ethical Issues in International

Research. Ed. R Cash, D. Wikler, A. Saxena, A. Capron . 2009)

4.4. The Secretariat shall collect Ethics Review Form (SL-IERC Form#05Bimmediately after the

decision.

4.5. Notice of Action

4.5.1. The Secretariat shall prepare the Notice of Action (NOA) stating the decision of the committee for appropriate action of the Principal Investigator and shall ask the IERC Chair to sign.

4.5.2. The Secretariat shall deliver the NOA to the appropriate recipient with an Acknowledgement Receipt.

4.5.3. The Secretariat shall file the document in the appropriate folder.

---Noting Follows---


STANDARD OPERATING PROCEDURE Full-Board Review of Protocols



1. PURPOSE

To provide criteria for classifying study protocols for expedited review, as well as instructions for

expedited review and approval of study proposals with minimum risk to participants.

2. SCOPE From classifying protocols for review to the process of expedited review and approval.

3. FLOWCHART


Executive Secretary

4. PROCEDURE 4.1. The following criteria shall be used as basis for classifying protocols for expedited review:

Protocols that entail only a minimal risk to the human participants and to the community

Protocols that are retrospective in data collection methodology.


Expedited Review


Establishment of criteria for expedited review

Recommendation of protocols for expedited review

Reporting of results in a regular IERC meeting to the IERC

Preparation of summary of recommendations

and Notice of Action for PI


Evaluation of protocols submitted to determine type of review (Expedited or

Full review)

Conduct of expedited reviewby referendum

Executive Secretary

Approval of protocols for expedited review and designation of IERC member to conduct

Expedited Review

IERC Chair

Sending of protocols to IERC members who will conduct expedited Review

Designated IERC

members

Secretariat

Executive Secretary

Submission of results of Expedited Review to

Secretariat

Designated IERC

members


Protocols previously approved by IERC (for a period of 1 year or less) which have minor changes and need authorized approval ( 21 CFR 56.110)

4.2. Evaluation and classification of protocols for expedited review 4.2.1. The Executive Secretary shall evaluate if a submitted protocol is qualified for expedited

review based on the above criteria and makes recommendation to the IERC Chair. 4.2.2. The IERC Chair shall endorse the protocol for expedited review and designate at least 2

IERC members who will conduct the expedited review. 4.2.3. The Secretariat shall prepare and send the protocol to the designated members of the

IERC.

4.3. Conduct of expedited review 4.3.1. The Secretariat shall send copies of the protocol to designated members of the IERC. 4.3.2. The IERC members shall be given two weeks to evaluate the protocol using the Ethics

Review Form (SL-IERC Form# 05B. 4.3.3. The recommendations of the reviewers may be any of the following:

Approved

With revisions

Full Board Review 4.3.4. The IERC reviewers shall submit to the Secretariat the results of the expedited review. 4.3.5. The Executive Secretary shall summarize the results of the expedited review

4.4. The Executive Secretary shall send a Notice of Action to the principal investigator. 4.5. The Executive Secretary shall report the outcome of the expedited review to the IERC during a

regular meeting. 4.6. The Secretariat shall keep the results and document in an active file.



STANDARD OPERATING PROCEDURE Expedited Review



Document History


REVIEW COMMITTEE Continuing Review and

Monitoring of Protocols



1 10-

2012

1

Compliance with suggestions of

FERCAP surveyors


Executive Secretary

Prospero Ma. C. Tuaňo, MD IERC Chair

April 2013


CHAPTER 4


REVIEW COMMITTEE

Continuing Review and Monitoring of Protocols 4.1. Review of Protocols That Require Major Revisions

after Presentation 4.2. Review of Protocol Amendments 4.3. Progress Reports for Continuing Review 4.4. Assessment of Serious Adverse Events 4.5. Early Termination of Clinical Trials Due to Protocol

Violations 4.6. Site Visit


1. PURPOSE

To describe how study protocols that have been evaluated and recommended with minor or major

revisions are managed, reviewed and approved by the IERC.

2. SCOPE

From preparation of Notice of Action (NOA) and receipt of Response to Notice of Action to second

review by the IERC of study protocols that require minor and major revisions

3. FLOWCHART


Secretariat


Review of Protocols that require revisions after presentation


Preparation and sending of Notice of

Action (NOA) to Principal

investigator/Proponent

Protocol with Minor

Revisions - Expedited

Review

Communication to Principal Investigator/Proponent re IERC decision

Response to NOA

Protocol with Major

Revisions- Full-board

Review

Designated IERC members

IERC

Secretariat

Decision presented to the

IERC during regular

meeting

Executive Secretary


4. PROCEDURE

4.1. Notice of Action and Response

4.1.1. The Secretariat shall prepare the Notice of Action (Refer to SL-IERC Form# 12A) and shall send it to the Principal Investigator/ Proponent.

4.1.2. Principal Investigator/ Proponent shall acknowledge the Notice of Action by signing the Acknowledgement Receipt.

4.1.3. Principal Investigator/ Proponent shall be given a time frame of one month to response to the Notice of Action.

4.2. Review of Response to Notice of Action

4.2.1. Protocol with minor revision(s) shall pass through expedited review. Refer to SOP 3.5 for

expedited review process. 4.2.2. Protocol with major revision(s) shall pass through another full review.

4.2.2.1. The Executive Secretary shall present the protocol and the pertinent major revisions.

4.2.2.2. The IERC shall deliberate on the revision and decide by consensus as follows:

Approved

Disapproved

4.3. Decision/Notice of Action 4.3.1. The Secretariat shall inform the Principal Investigator of the decision.



Review of Protocols that require revisions after presentation



1. PURPOSE

To describe how amendments to study protocols are reviewed and approved by the IERC.

2. SCOPE From receipt of letter of request for approval of amendments to the review and approval by the IERC

3. FLOWCHART


Secretariat

IERC

Secretariat


4. PROCEDURE

4.1. The Secretariat receives and logs Letter of Request for approval of protocol amendments 4.2. The Executive Secretary classifies the amendments as follows:

4.2.1. Minor Amendments:

Minor changes to the protocol or other study documentation e.g. correcting errors, minor clarification

Changes in the principal investigator’s research team

Changes in the documentation used by the research team for recording study data

Changes in the contact details of the sponsor (or the sponsor’s representative), principal investigator or other study staff

4.2.2. Major amendments for:

Changes in the design or methodology of the study or in the background information that may affect its scientific value

Changes in the procedure undertaken by the participant which relates to the safety, physical or mental integrity of the participants.

Significant changes in the study documents such as participant information sheets, consent forms, questionnaires

Appointment of a new Principal investigator or key collaborator

Change in the insurance or indemnity arrangements for the study


STANDARD OPERATING PROCEDURE Review of Protocol Amendments


Receipt of Letter of Request from Principal Investigator/Proponent

Review of Request for Approval of Amendment

Submission of clean copy of

amended protocol

Communication to Principal Investigator re IERC decision


4.3. Presentation of Protocol amendments to the IERC

4.3.1. The IERC shall be informed of minor amendments during a regular meeting after they have passed expedited review

4.3.2. Major Amendments shall be presented by the IERC Chair/ Executive Secretary during a full board review.

4.4. The Executive Secretary shall prepare Notice of Action to the Principal Investigator regarding the decision of the IERC.

4.4.1. The amended protocol shall be stamped “IERC Approved” with date of approval.



STANDARD OPERATING PROCEDURE Review of Protocol Amendments



Preparation and distribution of Memorandum re: Submission of

Continuing Review Report (Downloadable at IERC web portal)

Report

Review of Progress Reports for

Continuing Review Report

Communication to Principal Investigator re: Continuing Review

Filing of Continuing Review Documents

1. PURPOSE

To describe the procedure of continuing review of studies involving human participants in order to ensure the continuous protection of their rights and safety and to provide instructions on the preparation of Progress Reports for Continuing Review.

2. SCOPE From submission of progress reports using Continuing Review Report Form (CRRF) and updates on Serious Adverse Events (SAEs) to tracking of reports received.

3. FLOWCHART


Executive Secretary

Secretariat

IERC

Secretariat

Secretariat

4. PROCEDURE

4.1. Progress Reports for continuing review

4.1.1. The Progress reports for Continuing Review shall include the following: (Refer to SL-IERC Form# 16)

Progress of the study

Occurrence of Serious Adverse Events

Occurrence of Unexpected Adverse Events (UAEs)

Rate of accrual of participants

Protocol deviations

Protocol violations


STANDARD OPERATING PROCEDURE Progress Reports for Continuing Review



4.1.2. The Executive Secretary shall prepare a memorandum to all Principal Investigators to

submit a progress report for Continuing Review. The frequency of submission of Progress Reports for Continuing Review shall depend on the level of risks of the study.

Low/Minimal Risk – Annually based on their approval date

Moderate/Medium Risk – Semi-annually

High Risk – Quarterly reporting

4.1.3. The Secretariat shall send the Memorandum to all Principal Investigators. 4.1.4. The Secretariat shall compile and include the progress reports of all ongoing Clinical

Trials in the agenda of a regular IERC meeting. 4.2. Continuing Review of CTs

4.2.1. The Secretariat shall include the presentation of Progress Reports for Continuing Review in the agenda of IERC regular meetings

4.2.2. The IERC Chair shall present the Progress Reports for Continuing Review for discussion.

4.2.3. The IERC shall make any of the following recommendations on each report:

Uphold original approval with no further action

Request information

Require further action

4.3. Communication to Principal Investigators

4.3.1. The Secretariat shall inform the Principal Investigators of the result of the continuing review of their clinical trials

4.3.2. The Secretariat shall inform Principal Investigators who have not submitted Continuing Review Reports.

4.4. The Secretariat shall file the continuing review documents in the respective study binders and in the SAE binders.



Progress Reports for Continuing Review



1. PURPOSE

To describe the procedure for reporting and assessment of serious adverse events (SAEs) that affect

the health, welfare and safety of human participants.

2. SCOPE

From the receipt of SAE Report Form (Refer to SL-IERC Form #14A) to evaluation/review of the

report by the IERC

3. FLOWCHART


Secretariat


STANDARD OPERATING PROCEDURE Assessment of Serious Adverse Events


Receipt of SAE Report Logging of SAE Report

Notification of IERC Chair

Inclusion of Report in the Agenda of IERC Meeting

Presentation of SAE Reports for Discussion

Review and Evaluation of SAE Reports

Preparation, Signing and Delivery of NOA

Secretariat

IERC Chair

IERC Chair and members

Secretariat and IERC Chair

Filing of Report and NOA in respective study binder and SAE binder Secretariat


3.1. SAE /SUSAR Reporting Oversight 3.1.1. Definitions:

3.1.1.1. SAE (Serious Adverse Event/Serious Drug Experiences) as defined under 21 CFR 312.32:

a) Any adverse drug experience occurring at any dose that results in any of the following outcomes:

Death

Life-threatening drug experience

Inpatient hospitalization or prolongation of existing hospitalization

Persistent or significant disability/incapacity

Congenital anomaly/birth defect b) Important medical events that may not result in death, be life-threatening or

require hospitalization but when based upon appropriate judgment may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes mentioned above.

3.1.1.2. Unexpected Adverse Drug Experience: Any adverse drug experience the specificity or severity of which is not consistent with the current investigator brochure or with the risk information described in the general investigational plan or elsewhere in the current application. “Unexpected” as used in this definition refers to an adverse drug experience that has not been previously observed or from the perspective of the pharmacological properties of the test product is not anticipated.

3.1.2. Principal investigators shall follow guidelines on submission of SAE reports in accordance with Monitoring of Clinical Safety of Investigational Drugs.

3.1.3. The Secretariat shall receive, acknowledge and date the SAE Report. 3.1.3.1. The Secretariat shall log the SAE Report in a Logbook for SAEs and in the SAE

Tracking Form filed in each Study Binder. (Refer to SL-IERC Form # 14B) 3.1.3.2. The SAE report shall indicate if the event is:

Unrelated to study

Unlikely related to study

Possibly related to study

Definitely related to study 3.2. The Secretariat shall forward a copy of the Report to the IERC Chair for immediate action.

3.2.1. The IERC Chair shall call for an emergency meeting of the IERC if there is an urgent need for early termination of a study because of the SAE reports.

3.2.2. If the SAE Report indicates “Unrelated” or “Unlikely” related to study, the Secretariat shall include the report in the IERC agenda for information.

3.2.3. If the SAE Report indicates “Possibly” or “Definitely” related to study, the Secretariat shall include the report in the IERC agenda for review and evaluation.

3.3. Review of SAE Reports

3.3.1. The Chair of IERC shall present the SAE reports that are for review and discussion. 3.3.2. The IERC shall note and discuss the relatedness and expectedness (SUSAR of all

onsite/offsite adverse events) 3.3.3. The IERC shall make a decision by consensus to:

Request an amendment to the protocol or the consent form

Request further information

Suspend or terminate the study





3.4. Notification of IERC action

3.4.1. If the decision of the IERC is any of the above, the Executive Secretary shall prepare a Notice of Action to the Principal Investigator.

3.4.2. The Secretariat shall ask the IERC Chair to sign the NOA. 3.4.3. The Secretariat shall deliver the NOA to the Principal Investigator.

3.5. Secretariat shall file the report and NOA in appropriate study binder and SAE binder.






1. PURPOSE

To describe the procedure and guidelines for termination of clinical trials due to protocol deviations

or violations

2. SCOPE

From the receipt of the report by the IERC Secretariat to notice of termination of the protocol by the

IERC (Refer to SL-IERC Form #18)

3. FLOWCHART


4. PROCEDURE

4.1. The secretariat shall receive the report on protocol deviations and violations

4.2. The Secretariat shall include the Protocol Deviation/Violation Report in the IERC agenda.

4.3. The IERC Chair shall present the report for discussion by the committee

4.3.1. The IERC shall make a decision to terminate a previously approved clinical trial based on the following considerations:

Safety reports that indicate that continuing the study will worsen the condition of, as well as increase the risks to the study participants

Recommendation by the Principal Investigator or the sponsor

Other considerations that impact on the risk/benefit ratio.


STANDARD OPERATING PROCEDURE Early Termination of Clinical Trials

Due To Protocol Deviations/Violations


Receipt of Report

Inclusion Report in IERC Meeting Agenda

Presentation of Report for Discussion

Decision by consensus

Filing of Report in the appropriate study binder

Secretariat

IERC Chair/Executive Secretary

IERC

Executive Secretary Notice of action

Secretariat

Secretariat


4.3.2. The IERC shall make a decision by consensus on the recommendation for early termination.

4.4. The Secretariat shall prepare a Notice of Action to Principal Investigator.

4.4.1. The Secretariat shall ask the IERC Chair to sign the NOA. 4.4.2. The Secretariat shall deliver the NOA to the Principal Investigator.

4.5. Secretariat shall file a report in the appropriate study binder.



STANDARD OPERATING PROCEDURE Early Termination of Clinical Trials

Due To Protocol Deviations/Violations



1. PURPOSE To describe the criteria and procedure for site visits.

2. SCOPE From identifying the site to be visited up to the recording and filing of the final report.

3. FLOWCHART



STANDARD OPERATING PROCEDURE Site Visit


IERC Chair/Secretariat

Secretariat

IERC

Secretariat

Designated person/s

members of the IERC

IERC /Secretariat

IERC

Secretariat

Secretariat

Secretariat

Designated person/s

members of the IERC

Designated person/s

members of the IERC

Identification of Principal Investigator (PI) and site to be visited

Informing IERC Chair /IERC

Discussion

Designation of person/s to conduct the site visit(maybe a group already formed and identified to

conduct visits)

Notification of PI/site of the visit

Review of informed consent and other pertinent documents

Preparation of report after the site visit

Presentation of report/findings to the IERC

IERC Deliberation and action on findings

Inform PI of findings and actions/sanctions of the IERC

Follow-up on action taken by PI after one month

File reports on respective protocol file


4. PROCEDURE

4.1. Criteria for selection of Principal Investigator/site to be visited 4.1.1. Number of clinical trials/studies handled by the Principal Investigator 4.1.2. Receipts of serious adverse events report on a clinical trial 4.1.3. Failure to submit progress report or final report 4.1.4. New Principal Investigator/site 4.1.5. Inquiry/complaint of clinical trial/study participant

4.2. Preparation of the Visit

4.2.1. The Secretariat shall inform the principal investigator of intended site visit of the designated persons/members of IERC.

4.2.2. Secretariat shall prepare the Site Checklist and other materials needed for the site visit.

4.3. During the Visit, the designated persons/members of IERC shall: 4.3.1. Review the informed consent and make sure that the most recent version is being used. 4.3.2. Review 25% of the participants files that participants are signing the right informed

consent 4.3.3. Observe the informed consent process if possible. 4.3.4. Review the files and documents and ensure that they are being filed properly and with

confidentiality

4.4. After the Visit 4.4.1. The team shall write a report based on the Site Visit Checklist. 4.4.2. The Secretariat shall file a copy of the report on the study file and this shall be

forwarded to the IERC for review.

4.5. Presentation of the site visit report to the Institutional Ethics Review Committee 4.5.1. The IERC shall deliberate on the findings of the site visit report. 4.5.2. The Secretariat shall relay to the Principal Investigator the action of the IERC on the site

visit report. 4.6. IERC secretariat shall follow-up the action taken by the Principal Investigator. 4.7. IERC secretariat shall keep record of the report, decisions and action taken on the respective

protocol file.



STANDARD OPERATING PROCEDURE Site Visit



CHAPTER 5


REVIEW COMMITTEE

Administrative Procedures 5.1. Preparation of Notice of Meeting and Agenda 5.2. Preparation and Distribution of Minutes of

Meetings 5.3. Emergency/Special Meetings 5.4. Preparation for a Regular Meeting 5.5. Conduct of a Regular Meeting 5.6. Management of Communication. 5.7. Management of Administrative Files, Logbooks and

Forms


1. PURPOSE To describe the procedures for the preparation of the agenda and notice of a regular IERC meeting

2. SCOPE

From the setting of the agenda and date of the meeting, to the distribution of meeting materials to

IERC members and filing of essential communication documents

3. FLOWCHART


Secretariat and Chair

Secretariat and all IERC members

Secretariat

Secretariat

Secretariat

Secretariat

4. ROCEDURE

4.1. Setting of Agenda of Meeting

4.1.1. The Secretariat, in consultation with the IERC Chair, shall prepare the Tentative Agenda (Refer to Agenda Template) for the Regular Meeting of the IERC.


Administrative Procedures- Preparation of Notice of Meeting and Agenda


Setting of Meeting Agenda

Setting date of the IERC

Meeting

Preparation and Distribution of

meeting materials

Notification and Confirmation of attendance of IERC members,

Notification of Presentors

Preparation of venue, dietary request , transport service and

honorarium for the meeting

Filing of all essential

documents


4.1.2. The standard agenda for a regular IERC meeting shall include the following:

Invocation

Call to Order

Verification of Quorum

Declaration of Conflict of Interest

Approval of Agenda

Reading and Approval of Minutes of the Previous Meeting

Matters Arising from the Previous Meeting

Presentation and Review of Protocols

Report on Adverse Events

Matters for Approval/Action – DSMC Reports

Matters for information Protocol Deviations Other Correspondences

o Study Updates o Reports o Renewal o Others

Safety Reports/CIOMS/SUSARS Investigator’s Brochures Study Close-out Notification

Other Matters

Schedule of next IERC meeting

Adjournment

4.2. Schedule and Date of IERC meetings 4.2.1. Regular meetings of the IERC shall be held on the 2nd Wednesday of each month at 8:00

in the morning, RBD conference Room, Annex 3, 5th Floor. 4.2.2. The schedule and date of IERC Meetings shall be posted at the RBD Bulletin Board on

the 2nd floor bridge way and at the Clinical Trials Web portal

4.3. Notification of IERC members and Notification of Presentors 4.3.1. The Secretariat shall send a “Notice of Meeting” to all members of the IERC signed by

the IERC Chair 2 weeks prior to the scheduled meeting. The Secretariat shall confirm attendance of IERC members through phone and/or short message service (SMS).

4.3.2. The secretariat shall send the “Tentative Agenda of the Meeting” and other materials to IERC members at least one week before the meeting.

4.3.4. The Secretariat shall send a letter of “invitation to present” to all proponents one week before the scheduled presentation for review by the IERC, with specific instructions to discuss the following ethical issues:

Social or scientific value

Scientific validity

Fair subject selection

Favorable risk ratio

Independent review

Informed consent

Respect for Potential and enrolled subjects


STANDARD OPERATING PROCEDURE Administrative Procedures-

Preparation of Notice of Meeting and Agenda



4.4. Preparation of venue and requests from other concerned Divisions 4.4.1. The Secretariat shall reserve the use of the RBD Conference Room for the IERC meeting 4.4.2. The Secretariat shall prepare the following requests:

Dietary Request Form to Food and Nutrition Department

Transport Request Form to Transport Services Department

Check Preparation Request for IERC honorarium to Accounting Department

4.5. Distribution of meeting materials 4.5.1. The Secretariat shall prepare for each IERC member a binder containing the following

documents for the meeting:

The Tentative Agenda for the Meeting(refer to Agenda Template)

Minutes of the Previous Meeting

Copy of all protocols for review

4.5.2. The IERC Chair shall receive a copy of the following for discussion

Secretariat Report which contains list of SAEs, Request for Amendments, DSMC Reports

Correspondences, Response to Notice of Action

Other Matters for Approval

4.5.3. The Secretariat shall distribute the binder to each IERC Member at least 1 week prior to the scheduled meeting.

4.6. Filing of essential documents

4.6.1. The Secretariat shall file the following essential documents:

Notice of meeting

Invitation to Presentors

Approved Agenda

Approved Minutes

Action for Continuing review of protocols




Preparation of Notice of Meeting and Agenda



1. PURPOSE To describe the procedures for the preparation of the draft of the minutes and its final approval

2. SCOPE From the preparation of the draft of the minutes to filing of the approved minutes

3. FLOWCHART


Secretariat

Secretariat

Secretariat

IERC Chair

Secretariat/IERC members

Secretariat

4. PROCEDURE

4.1. Recording of Minutes 4.1.1. The Secretariat shall record the proceedings of an IERC meeting. 4.1.2. Minutes of an IERC meeting shall be recorded in an MP3 recorder. 4.1.3. The Secretariat shall copy the MP3 record to a compact disc and shall label the compact

disc with a sticker indicating the date (year, month, day). 4.1.4. The Secretariat shall place the compact disc in a CD clear sheet as electronic file of the

Minutes in the IERC Secretariat office. 4.2. Preparation of draft copy of the Minutes (refer to template of Minutes of Meeting)

4.2.1. The Secretariat shall prepare the draft copy of the Minutes using the following format:

Date and venue of the meeting

Attendance/Absences

Person presiding

Declaration of Quorum

Time when the meeting started

Items discussed in the final agenda

Decision on matters discussed i.e. approval/disapproval of clinical trials

Schedule of the next IERC Meeting



Preparation and Distribution of Minutes


Minutes recorded in an MP3 are copied to a Compact Disc CD)

Sending of the draft of the Minutes to the IERC Chair for revisions/corrections

Revisions/corrections in the

Minutes made

Filing of Approved Minutes

Preparation of draft of the Minutes based on MP3 record

Printing of final version of the Minutes and

distribution to IERC Members


4.2.2. The Secretariat shall send the draft of the Minutes to the IERC Chair for revisions/corrections.

4.3. Revisions and corrections in the drafts of the Minutes 4.3.1. The IERC Chair shall make corrections in the draft of the Minutes. 4.3.2. The Secretariat shall incorporate the corrections and print the final version of the

Minutes. 4.3.3. The IERC Chair and person who prepared the minutes shall sign the final version of the

Minutes 4.3.4. The Secretariat shall distribute the printed final version of the Minutes to individual IERC

members together with the Tentative Agenda of a regular meeting.




Preparation and Distribution of Minutes



1. PURPOSE

To describe the procedures in recognizing and evaluating events/situations that will require an emergency/special meeting and the conduct of such meetings.

2. SCOPE From evaluating events or situations, making a decision, giving notice, and conducting emergency meetings, to adjournment and communication of decisions made.

3. FLOWCHART

ACTIVITY PERSON/S RESPONSIBLE

IERC Chair, Executive Secretary, IERC

members, Medical Director, VP for RBD, Quality Officer of SLMC

IERC Chair

Secretariat

IERC Chair

Secretariat

4. PROCEDURE

4.1. Evaluating events/situations and deciding to call for an emergency meeting of the IERC: 4.1.1. The following events/situations will require an emergency meeting of the IERC:

Occurrence of an unexpected serious adverse event that will be life-threatening to study participants

Recall of study drug by regulatory authorities

Other urgent issues as identified by IERC team, CCT team, SLMC administration officials.

4.1.2. After an evaluation of the event/situation, the IERC Chair shall call for an emergency meeting of the IERC

4.1.3. The Secretariat shall send a Notice of Emergency Meeting to IERC members, including resource persons, if needed.


STANDARD OPERATING PROCEDURE Administrative Procedure-Emergency/Special Meetings


Evaluating events/situations

Making a decision to have an Emergency Meeting

Sending of Notice of Emergency Meeting

Conduct of Meeting

Communication of decision and

filing of documents


4.1.4. The Secretariat shall prepare the Agenda and relevant materials for the emergency

meeting

4.2. Conduct of Meeting 4.2.1. The IERC Chair shall determine the presence of a quorum. 4.2.2. The IERC Chair shall immediately present the relevant issues for discussion and shall

ensure that the issues are resolved in the meeting. 4.2.3. The IERC shall make a decision on the issues by consensus. The Secretariat shall record

and take minutes of the meeting.

4.3. Communication of decision and filing of documents 4.3.1. The Secretariat shall prepare the Notice of Action to be signed by the IERC Chair 4.3.2. The Secretariat shall deliver the NOA to the person concerned. 4.3.3. The Secretariat shall file the relevant materials and documents appropriately



STANDARD OPERATING PROCEDURE Administrative Procedure-Emergency/Special Meetings



1. PURPOSE To describe the procedures in the preparation for a regular IERC meeting

2. SCOPE From making the room reservation to the start of the meeting

3. FLOWCHART


4. PROCEDURE

4.1. Preparation of venue and requests to other concerned Divisions 4.1.1. The Secretariat shall reserve the use of the RBD Conference Room for the IERC meeting 4.1.2. The Secretariat shall prepare the following requests:

Dietary Request Form to Food and Nutrition Department

Transport Request Form to Transport Services Department

Check Preparation Request for IERC honorarium to Accounting Department


STANDARD OPERATING PROCEDURE Administrative Procedure-

Preparation for a Regular IERC Meeting


Reservation of venue, Preparation of requests from Food & Nutrition, Transport service and

Accounting Departments

Preparation of meeting materials (Agenda, Minutes of previous meetings, Protocols for

review) and consolidation in a binder

Distribution of binders to IERC Members

Follow up reminders to IERC Members/PIs /Food and Nutrition Dept./Transport

Services/Accounting

Preparation of venue and distribution of individual evaluation sheets to IERC members

Arrival of IERC Members and Presenters/PI

Secretariat

Secretariat

Secretariat

Secretariat

IERC Members and

Presenters/PIs

Chair of IERC Start of Meeting

Secretariat


4.2. Preparation and distribution of meeting materials 4.2.1. The Secretariat shall prepare a binder containing the following documents for the

meeting for each IERC member:

The Tentative Agenda for the Meeting

Minutes of the Previous Meeting

All protocols for review

4.2.2. In addition, the IERC Chair shall receive a copy of the following for discussion

Secretariat Report which contains list of SAEs, Amendments, Safety Reports,

Correspondences

Other Matters for Approval 4.2.3. The Secretariat shall distribute the binder to each IERC Member at least 1 week prior to

the scheduled meeting.

4.3. Before the day of the meeting, the Secretariat shall be responsible for: 4.3.1. Determining if there will be a quorum for the meeting 4.3.2. Preparing the Tentative Agenda for distribution on the day of the meeting 4.3.3. Follow up reminders to the following departments:

Food and Nutrition

Transport Service Dept.

Accounting Dept.

Housekeeping Dept. 4.3.4. Preparation of the following:

Individual Evaluation Sheets

MP3 recorder

Laptop and LCD projector

References on Research Ethics

4.4. Day of the Meeting 4.4.1. The administrative support staff shall see to it that

the venue is ready

the pertinent documents are available(i.e. Agenda and protocols for review) are placed on the table

breakfast is set on the buffet table 4.4.2. The Secretariat shall usher the IERC members to the meeting room. 4.4.3. The Secretariat shall usher the Presentors to the Reception area where they can have

breakfast while waiting for their turn. 4.4.4. The Secretariat shall give the Ethics Review Forms, if any, to the IERC Chair

4.5. Start of Meeting

4.5.1. The Secretariat shall occupy a seat in the meeting room and shall turn on the MP3 recorder placed beside the IERC Chair.

4.5.2. The IERC Chair shall ask the Secretariat if there is a quorum. 4.5.3. The IERC Chair shall call the meeting to order . (Refer to SL-IERC SOP on Conduct of a

Regular IERC Meeting) ---Nothing Follows---



Preparation for a Regular IERC Meeting



1. PURPOSE To describe the procedures in the conduct of a regular IERC meeting

2. SCOPE From start of the meeting to adjournment

3. FLOWCHART


4. PROCEDURE

4.1. Start of meeting 4.1.1. The IERC meeting shall be conducted in accordance with the sequence as prepared in

the Agenda. 4.1.2. After the Invocation, the Chair shall call the meeting to order 4.1.3. The Chair shall ask the Secretariat if there is a quorum.

Quorum will be declared if: ( 21 CFR 56.108 c) majority of the IERC members are present but should not be less than 5. Moreover, at least one member whose primary concerns are not in scientific areas is present

If there is a quorum, the Chair shall proceed.

If no quorum exists, the Chair shall declare adjournment.

4.1.4. The Chair shall ask for the approval of the agenda. 4.1.5. The Chair shall ask if any member of the IERC has a conflict of interest in any of the

proposals for review.

Conflict of Interest is present when an IERC member has affiliation with a Principal Investigator or institute which will undermine his/her ability to make a free and independent evaluation.

If any member of the IERC declares a conflict of interest in any of the protocols for review, the Chair/IERC shall request the concerned member not to participate in the decision-making of the specified protocol.

If there is no declaration of any conflict of interest, the Chair shall proceed with the next item in the Agenda.



Conduct of a Regular IERC Meeting


Meeting Proper/Recording of minutes/Assistance to Principal Investigators for their oral presentation

Adjournment

IERC Chair

Secretariat

Secretariat

Secretariat

Compilation of Evaluation Sheets

Distribution of IFF to presenters

Collection of IFF from presenters

Secretariat

Call to Order


4.1.6. The Chair shall present the Tentative Agenda for approval/revision.

4.2. Conduct of meeting

4.2.1. The IERC Chair shall

present the Minutes of the Previous Meeting for Reading and Approval

discuss matters arising from the minutes

4.2.2. Presentation of Clinical Trial Protocols/Research Proposals 4.2.2.1. The IERC Chair shall call and introduce the presentor 4.2.2.2. The IERC Chair shall facilitate interpolation 4.2.2.3. Before the presenter leaves, the Secretariat shall request him to fill up and sign

the following:

Attendance Sheet

an Internal Feedback Form (IFF) to serve as his evaluation of the services provided by the Secretariat (Refer to HRD-ODD-PAMS-4-03-00)

4.2.3. The IERC Chair shall present other items as listed in the Agenda 4.2.3.1. Items for review and discussion:

Protocol Amendments

Site Specific Informed Consent Forms

Serious Adverse Events

Posters/Advertisement for patient recruitment

Other administrative matters 4.2.3.2. Items for information 4.2.3.3. Other Matters

4.3. Adjournment

4.3.1. The Chair shall adjourn the meeting after confirmation of the date of the next Regular Meeting.

4.3.2. The Secretariat shall

turn off the MP3 recorder

distribute honorarium checks and relevant documents to members of the IERC.

call transport service to bring community member to her office/residence.

call Housekeeper to clean the meeting venue.

collect all binders and keep these on file at the IERC Office.




Conduct of a Regular IERC Meeting



1. PURPOSE

To describe the procedures that will ensure proper logging, distribution and documentation of all

communications to and from the IERC, as well as communications related to functions of the Center

for Clinical Trials.

2. SCOPE From the distribution and receipt to the recording and filing of communications.

3. FLOWCHART: The Secretariat is responsible for all the following activities:

4. PROCEDURE

4.1. Secretariat shall classify all communications as follows:

Incoming or outgoing

Protocol-related or non-protocol-related

4.2. Incoming/Outgoing Communications

4.2.1. The Secretariat shall record all incoming communications in a Logbook chronologically

4.2.2. The Secretariat shall distribute outgoing communications to appropriate recipients.




Management of Communications


Classification of communications into protocol-related and non-protocol-related, incoming and

outgoing

For incoming, protocol-

related communications:

Filing of communications in

appropriate binders

For outgoing communications: Distribution to appropriate

recipients

Recording of all communications in a Logbook


1. PURPOSE To describe the procedures in the management of administrative files, logbooks and forms. These include manuals, references, Tracking Forms and other administrative files.

2. SCOPE From generation to disposal of administrative files, logbooks and forms.

3. FLOWCHART


IERB Chair and Members

Executive Secretary and Secretariat

Secretariat

Secretariat

Secretariat

4. PROCEDURE

4.1. The IERC Secretariat shall receive documents that are not Protocol-related such as:

reference materials

letters to IERB Chair

members and investigator profiles

logbooks and files

forms 4.2. The IERC Secretariat shall sort out documents to protocol-related, non-protocol-related and

administrative in nature.


STANDARD OPERATING PROCEDURE Administrative Procedures- Management of

Administrative Files, Logbooks and Forms


Generation of various documents and

records

Sorting of accumulated

documents and records

Maintenance and storage of documents and records in

appropriate files

Archiving, destruction and

disposal of unnecessary files


4.3. The IERC Secretariat shall maintain the following Logbook files:

Active Study files which include files of on-going researches shall contain: CT Tracking Form SAE Tracking Form Correspondence

o Submission Letter o Invitation to present o Notice of Action (NOA) o Response to NOA o Ethical Clearance o Principal Investigator’s Responsibilities signed conforme o o IERC Members Composition

Submissions o Protocol o Investigator’s Brochure o Informed Consent Forms o Sample CRF o Patient Recruitment materials/Ads/Posters o Principal Investigator’s CV o GCP Certificate o Malpractice Insurance o PFDA approval o Amendments o SAE Reports o Line Listing of CIOMS/Safety Reports/SUSARS o Protocol Deviations

Archived Files which includes protocol on research that are completed, terminated, withdrawn or closed out shall contain :

Files of SAEs, SUSARs and CIOMS Meeting Agenda, Attendance, and Minutes of IERC meetings Progress Report Files Forms and List of Forms IERC SOPs

4.4. Destruction and disposal of documents

4.4.1. The Secretariat shall shred and dispose:

unused protocols and related documents

archived documents beyond the retention period

4.4.2. After shredding, all dry waste are collected in a black bag.

(Refer to Waste Management Policy-MED-***-ICS-1-02-03)



STANDARD OPERATING PROCEDURE Administrative Procedures- Management of

Administrative Files, Logbooks and Forms



SL-IERC FORMS


REVIEW COMMITTEE


LIST OF SL-IERC FORMS

FORM DESCRIPTION FORM #

1. Agreement on Confidentiality and Conflict of Interest Form SL-IERC FORM#01A

2. Agreement on Confidentiality and Conflict of Interest Form (for Preliminary Reviewer)

SL-IERC FORM#01B

3. Initial Protocol Review Submission Form SL-IERC FORM#02

4. Initial Protocol Review Submission Acknowledgment Form SL-IERC FORM#03

5. CT Tracking Form SL-IERC FORM#04

6. Technical Review Form SL-IERC FORM#05A

7. Ethics Review Form SL-IERC FORM#05B

8. Notice of Meeting SL-IERC FORM#06A

9. Notice of Emergency Meeting SL-IERC FORM#06B

10. Invitation to Present SL-IERC FORM #08

11. IERC Attendance Sheet SL-IERC FORM #09A

12. Attendance Sheet for Presentors SL-IERC FORM #09B

13. Principal Investigator’s Responsibilities SL-IERC FORM #10

14. Notice of Action SL-IERC FORM #12A

15. IERC Composition SL-IERC FORM #12B

16. Ethical Clearance SL-IERC FORM#13A

17. Request for Ethical Clearance Renewal SL-IERC FORM#13B

18. Ethical Clearance Renewal Form SL-IERC FORM#13C

19. SAE Form SL-IERC FORM#14A

20. SAE Tracking Form SL-IERC FORM#14B

21. Protocol Deviation/Violation SL-IERC FORM#15

22. Continuing Review Report Form SL-IERC FORM#16

23. Agenda Template SL-IERC FORM#17

24. Minutes of the Meeting Template SL-IERC FORM#18

25. Final Report SL-IERC FORM#19


(SL-IERC FORM#01A)

Agreement on Confidentiality and Conflict of

Interest Form (For IERC Members)


(SL-IERC FORM#01B)

Agreement on Confidentiality and Conflict of

Interest Form (For Preliminary Reviewer)


(SL-IERC FORM#02)

Initial Protocol Review Submission Form


(SL-IERC FORM#03)

Initial Protocol Review Submission

Acknowledgment Form


(SL-IERC FORM#04)

CT Tracking Form


(SL-IERC FORM#05A)

Preliminary Technical Review Form

Page 1 of 2


(SL-IERC FORM#05A)

Preliminary Technical Review Form

Page 2 of 2


(SL-IERC FORM#05B)

Ethics Review Form

Page 1 of 4


(SL-IERC FORM#05B)

Preliminary Ethics Review Form

Page 2 of 4


(SL-IERC FORM#05B)


Page 3 of 4


(SL-IERC FORM#05B)


Page 4 of 4


(SL-IERC FORM#06A)

Notice of Meeting


(SL-IERC FORM#06B)

Notice of Emergency Meeting


(SL-IERC FORM#08)

Invitation to Present

(Page 1 of 2)


(SL-IERC FORM#08)

Invitation to Present

(Page 2 of 2)


(SL-IERC FORM#09A)

IERC Attendance Sheet


(SL-IERC FORM#09B)

Attendance Sheet for Presentors


(SL-IERC FORM#10)

Investigator’s Responsibilities


(SL-IERC FORM#12A)

Notice of Action


(SL-IERC FORM#12B)

IERC Composition as

Attachment to Notice of Action


(SL-IERC FORM#13A)

Ethical Clearance


(SL-IERC FORM#13B)

Request for Ethical Clearance Renewal


(SL-IERC FORM#13C)

Ethical Clearance Renewal Form


(SL-IERC FORM#14A)

SAE Form


(SL-IERC FORM#14B)

SAE Tracking Form


(SL-IERC FORM#15)

Protocol Deviation/Violation Form


(SL-IERC FORM#16)

Continuing Review Report Form

(Page 1 of 2)


(SL-IERC FORM#16)

Continuing Review Report Form

(Page 2 of 2)


(SL-IERC FORM#17)

Agenda Template


(SL-IERC FORM#18)

Minutes of the Meeting Template


(SL-IERC FORM#19)

Final Report Form


GLOSSARY


REVIEW COMMITTEE


Adverse events - any untoward or undesirable medical occurrence in a patient or participant in clinical investigation after use or administration of an investigational product. This is not necessarily caused by the treatment. See also adverse drug reaction, serious adverse event and unexpected adverse event.

Amendment to the

protocol

- A written description of a change(s) to, or formal clarification of a protocol and changes on any other supporting documentation made from the originally approved protocol by the research ethics review body after the study has began. See protocol amendment.

Approval - favorable or affirmative decision of the Research Ethics Committee following a review of the protocol and other required documents and thus research may already be started and undertaken as set forth by the ethics committee, CPG, the institution, and relevant regulatory terms.

Assent - authorization for one’s own participation in research given by a minor or another subject who lacks the capability to give informed consent. The assent is a requirement for research in addition to consent given by a parent or legal guardian; It is agreement by an individual not competent to give legally valid informed consent like a child or cognitively impaired person to participate in research. See also child’s assent and surrogate assent.

Center for Clinical

Trials

This is one of the Centers of the Research and Biotechnology Division of St. Luke’s Medical Center-Quezon City that has the mandate for the administration and management of clinical trials at St. Luke’s. The budget of the IERC Secretariat is channeled through this Center

Clinical research - is a study undertaken involving a particular person or group of people with the purpose of increasing knowledge and determining how well treatment or diagnostic test works in a particular patient population. The NIH-USA defines clinical research as: Patient-oriented research involves a particular person or group of people or uses materials from humans. This research can include: Studies of mechanisms of human disease; Studies of therapies or interventions for disease; Clinical trials and Studies to develop new technology related to disease. Epidemiological and behavioral studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions. Outcomes and health services research seeks to identify the most effective and most efficient interventions, treatments, and services.”

Clinical trials - is a planned scientific research or study among human volunteers to determine the effects of treatment or diagnostic test on their safety, efficacy, and its effect on quality of life. It is also a systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reactions to investigational products, and/or to study the absorption, distribution, metabolism, and excretion of the products with the object of ascertaining their efficacy and safety (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products) It is also defined as investigative work to evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly scientifically controlled settings. Clinical trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. See also clinical research.

Dossier - a file containing detailed records on a particular person or subject. (Merriam-Webster Dictionary)

Ethical clearance - a certification that a research proposal has complied with ethical requirements; action of an ethics review committee on a research protocol that signifies approval and permission to proceed with the research. See approval

Ethics review - the evaluation of a research protocol by an ethics review committee to promote the safety and protection of the dignity of human participants. This a systematic process by which this independent committee evaluates a study protocol to determine if it follows ethical and scientific standards for carrying out biomedical research on human participants. It checks if the protocol complies with the guidelines to ensure that the dignity, rights, safety and well-being of research participants are promoted.

Ethics review

committee

- also called research ethics committee (REC), institutional ethics review board - (IERB), independent ethics committee (IEC) or institutional review board (IRB) -

committee constituted to review the ethical aspects of a research proposal and its possible implementation. This is an independent body whose responsibility is to ensure the protection of the rights, safety and well-being of human participants involved in a trial and to provide public assurance of that protection. See also research ethics committee


REVIEW COMMITTEE

GLOSSARY


Expedited

review

- is an ethics review of research protocol by the IRB chair or a designated voting member or subgroup of voting members rather than by the entire IRB. This is done for some research involving no more than minimal risk and maybe for minor changes in approved research, annual renewals of approved projects, approval of protocol amendments, research conducting health record review, and for confirming changes required by the ethics committee for approval of the protocol.

Full board

review

- review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting

Good clinical

practice

guidelines

(GCP)

- an international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with these standards provide public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the International Declaration of Helsinki, and that the clinical trial data are credible. These are standards and procedures for clinical trials that encompass the design, protocol approval, monitoring, termination, audit, analyses, reporting, and documentation of human studies. It defines the responsibilities and activities of the sponsor, principal investigators and monitor involved in the clinical trials. The GCP ensures that the studies are scientifically and ethically sound, and all the clinical properties of the product under investigation are properly documented. For complete information, reference is made to the published WHO and International Conference on Harmonization Code of Good Clinical Practice. (Department of Health Administrative Order No. 47-A series of 2001, [August 30, 2001); It is a standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of the studies and which ensures that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical products (diagnostic, therapeutic or prophylactic) under investigation are properly documented (World Health Organization, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products).

Guidelines - a set of rules or recommendations intended to effect a course of action.

Health

research

- generation of new knowledge (biomedical, clinical, social) to identify and deal with health problems, health systems and policies as well as those that impact on health such as socioeconomic, environment, energy and agricultural policies (PNHRS TWG Chairs, Feb 2004). This is composed of investigational activities that aim to generate data that shall contribute to improvement in the diagnosis, prevention and management of diseases, and in the delivery of care and for the enhancement of the quality of life of individuals and health conditions in communities. See also clinical research.

High-risk

group

- social group known to have a high prevalence of a health problem because of shared environmental, occupational, nutritional or genetic factors including practices that contribute to ill-health.

Human

subjects

- See research participants and respondent

Resource

Person

- an expert who gives advice(s), comment(s) and suggestion(s) upon review of the study protocols; with no affiliation to the institute(s) or investigator(s) proposing the research proposal.

Informed

consent

- the process of obtaining approval to participate in an investigative study or permission to a medical intervention. Consent must be freely given in verbal, video or written form. An important part of the process is the adequacy, appropriateness, and timeliness of the information for decision-making; It is “a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation” (CIOMS, 2002).


REVIEW COMMITTEE

GLOSSARY


Informed

Consent

Document

- A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Investigator - a person responsible for the conduct of the critical trial at a trial site. If trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and be called the principal investigator (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6, R1); It is a person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The investigator should have qualifications and competence in accordance with local laws and regulations as evidenced by an up-to-date curriculum vitae and other credentials. Decisions relating to, and to provisions of, medical or dental care must always be the responsibility of a clinically competent person legally allowed to practice medicine or dentistry (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products); The investigator must be a qualified scientist who undertakes scientific and ethical responsibility, either on his/her behalf or on behalf of an organization, for the ethical and scientific integrity of a research project at a specific site or group of sites See principal investigator

Investigator’s

Brochure

- compilation of all relevant clinical and non-clinical information and data on the investigational product.

Minimal risk the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. (45 CFR 46.102)

-

Monitor - a person appointed by and responsible to the sponsor or contract research organization for monitoring and reporting progress of the trial and for verification of data (WHO, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)

Monitoring - is the process of checking or scrutinizing research participants’ health status during a clinical trial, and/or to oversee the progress of a trial or research and/or to check researcher's compliance with the protocol and regulatory requirements with in which the protocol is given ethical approval

Philippine

Health

Research

Ethics Board

- was created on March 1, 2006 through DOST Special Order No. 091 series of 2006 as a policy-making body for research ethics in the Philippines

Principal

investigator

- the chief or person primarily responsible for the implementation of a research project See also investigator

Privacy - is the right or claim or state or ability or condition of an individual or group or institution to conceal or seclude or hide themselves or information about themselves and thus reveal or expose themselves selectively; It is a conceptual space defining the individual’s boundary as a person, intrusion of which is limited by human rights and by law. It is right to determine when, how, and to what extent information about someone is communicated to others

Protocol - a document that provides the background, rationale, and objective(s) of a biomedical research project and describes its design, methodology, and organization, including ethical and statistical considerations. Some of these considerations may be provided in other documents referred to in the protocol. (WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22); a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. (International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.44).


REVIEW COMMITTEE

GLOSSARY


Protocol

amendment

- a written description of a change(s) to, or formal clarification of a protocol. (WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22) See amendment to protocol

Regulatory

requirements

- necessary prerequisites for the approval and conduct of clinical trial by a national regulatory authority. For example, for pharmaceutical and biologic products it means obtaining a “permit for clinical investigational use” which is a “registration document issued by the FDA for the purpose of allowing the conduct of Phase I, Phase II, and Phase III clinical trials of investigational biologic products in the country” DOH Administrative Order No. 47-A series of 2001”Rules and Regulations on the registration including approval and conduct of clinical trials, and lot or batch release certification of vaccines and biologic products.” See Permit for clinical investigational use.

Research ethics

committee

- is an independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. International Conference on Harmonization (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.27) See also Institutional Ethics Review Committee, Cluster research ethics committee, ethics review committee

Research

participants or

subjects

- An individual who participates in a biomedical research project, either as the direct recipient of an intervention (e.g., study product or invasive procedure), as a control, or through observation. The individual may be a healthy person who volunteers to participate in the research, or a person with a condition unrelated to the research carried out who volunteers to participate, or a person (usually a patient) whose condition is relevant to the use of the study product or questions being investigated. (WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22)

Research protocol - a document that provides the background rationale and objective(s) of a biomedical research project and describes its design, methodology and organization, including ethical and statistical considerations. Some of these considerations may be provided in other documents referred to in the protocol. See also protocol

Risk - the probability of discomfort or harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Risks to research participants must be justified by the anticipated benefits to the subjects or to society. The investigator(s) and IRB must assess the risks and benefits of proposed research. See also minimal risk.

Risk-benefit ratio - The risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated. (clinicaltrial.gov/ct2/info/glossary)

Risk factors - are variables or conditions that increase the risk or chances of disease or infection; determinants of disease development. Also see risk.

Serious adverse

event

- or serious adverse drug reaction is an adverse event that results to death, life- threatening incident or causes immediate risk of death from the event; results to

inpatient or prolongation of hospitalization, causes significant disability, incapacity, and

congenital anomaly or another episode which is considered a significant hazard to the

participant. See also adverse event or unexpected adverse event. Also, any untoward

medical occurrence that at any dose: - results in death, - is life-threatening, - requires

inpatient hospitalization or prolongation of existing hospitalization, -results in persistent

or significant disability/incapacity, or - is a congenital anomaly/birth defect

(International Conference on Harmonisation (ICH) - Guideline for Good Clinical Practice

(GCP) E6 (R1), art. 1.50) See adverse event, adverse drug reaction


REVIEW COMMITTEE

GLOSSARY


Risk factors - are variables or conditions that increase the risk or chances of disease or infection; determinants of disease development. Also see risk.

Study Document - means all records, accounts, notes, report, data and ethics communications (submission, approval and progress reports) collected, generated or used in connection with the Study, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as CRFs and all other reports and records necessary for the evaluation and construction of the Study.

Unexpected

adverse event

- is an adverse reaction that has not been anticipated, nor previously experienced, or observed, and is not consistent with the informed consent, information sheets or applicable product information in the investigator’s protocol or brochure, product or package insert or summary of product characteristic. See also adverse event and serious adverse event

Voluntary - free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity. (IRB Guidebook, US DHHS in http://www.hhs.gov/ohrp/irb/irb_glossary.htm downloaded on June 19, 2010)

Vulnerability - refers to a substantial incapacity to protect one's own interests owing to such impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being a junior or subordinate member of a hierarchical group. (CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General Ethical Principles)

Vulnerable

persons/groups

- are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. (International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.61) Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests. (CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 9) These are also classes of individuals who have characteristics that lessen their capacity to protect their own interests or promote their own welfare; These are “persons whose situation or characteristics may make them unable to provide free and informed consent to participate in research. This group includes children, institutionalized persons, those who have cognitive impairments, and those in a position of inferiority” (http://www.pre.ethics.gc.ca.engish/tutorial/glossary.cfm#c down loaded on July 9, 2010)

Web portal - is a web site that brings together information from diverse sources in a unified way. (Wikepedia)


REVIEW COMMITTEE

GLOSSARY

http://en.wikipedia.org/wiki/Web_site


REFERENCES


REVIEW COMMITTEE


1. Philippine National Ethical Guidelines for Health Research 2011 handbook 2. International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6

3. International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E10

4. Protocol Risk assessment and Monitoring Guidelines of the North Carolina Translational and Clinical Sciences Institute; University of Kentucky Minimal risk definition

5. WHO- Casebook on Ethical Issues in International Research. Ed. R Cash, D. Wikler, A. Saxena, A.

Capron. 2009

6. WHO-Standards and Operational Guidance for Ethics Review of Health-Related Research with

Human Participants 2011

7. 21 CFR 56.110

8. http://www.hhs.gov/ohrp/irb/irb_glossary.htm

9. CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects

Revised draft, January 2002

10. WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva

2000, TDR/PRD/ETHICS/ 2000, p. 22St. Luke’s Policy on Monitoring of Clinical Safety of

Investigational Drugs

11. St. Luke’s Quality Procedures on the Ethical Review Clinical Trial Protocols

12. Reviewing Clinical Trials: A guide for Ethics Committees 2010

13. St. Luke’s Hospital Policy on Waste Management

14. St. Luke’s Hospital IFF Form HRD-ODD-PAMS-4-03-00

15. Merriam-Webster Dictionary


REVIEW COMMITTEE

REFERENCES

http://www.hhs.gov/ohrp/irb/irb_glossary.htm

St. Luke’ s Medical Center


For more information, please contact:

IERC SECRETARIAT

Direct Line: (632) 7275562 Trunkline: (632) 7230101 Locals: 7391/5562 Fax: (632) 7275562 Email: [email protected] Visit our website at: www.stluke.com.ph

Annex III, 5th Floor 279 E. Rodriguez Sr. Boulevard Quezon City 1102 Philippines