This section is required

Monitoring Log All NS-LIJ Health System IRB approved studies are subject to routine audits by the Office of Research Compliance and may also be reviewed by external entities such as the study sponsor or government agencies. Auditors and monitors should sign a monitoring log during every visit.

The Monitoring Log is maintained elsewhere; the location is identified below:

________________________________________________.

This section is required

Delegation of Responsibilities Log This section should include a log that lists all personnel involved in the research study, their specific responsibilities, signatures, initials, and IRB approval dates.

The Delegation of Responsibilities Log is maintained elsewhere; the location is identified below:

________________________________________________.

This section is required

Required Education All personnel involved in research with human subjects must complete the following: CITI Course in the Protection of Human Research Subjects IRB Researcher Registration Form (available online at www.nslij.com/irb) CITI COI Course: http://www.citiprogram.org/ Optional CITI Courses: Good Clinical Practice and Responsible Conduct of Research

This section should include: CITI course completion certificates or dates (however, certificates should be available

for auditors). You can also insert the IRB Required Education form in this section. (Completion dates are available online at www.nslij.com/irb)

Researcher registration forms Other relevant documents

If the required education documents are maintained elsewhere (such as in a master binder or electronic regulatory binder), please indicate the location in the table below:

Note: When adding personnel to the study, they must complete the required education and their addition must be IRB approved prior to participating in the study. All documentation must be kept, even for staff no longer participating in the study.

How to take the CITI course:

1. Go to www.citiprogram.org/ 2. Register, your participating institution is: “North Shore-LIJ Health System – New

York” 3. “Affiliations”: If you wish to use your training to meet requirements for more than 1

institution, after logging in click on the link to “Affiliate with another institution.” The advantage is that if the affiliated organizations require the same modules you will only need to complete the modules once. The software will give you credit in each institution's curriculum.

4. All Clinical Researchers must take the Basic/Refresher Course - Human Subjects Research (Biomedical, Behavioral, or Biomedical/behavioral) and the COI training.

Name of Educational Document Location

This section is required

CVs/Licenses/COIs

This section should include: Curriculum Vitae (signed & dated within the last 2 years) for

all investigators Professional licensure for all clinical investigators (including

DEA if applicable) Conflict of Interest disclosure form for all “covered”

investigators If these documents are maintained elsewhere (such as in a master binder or electronic regulatory binder), please indicate the location in the table below:

Document Location

This section is required

Subject Screening/Enrollment/ID Logs

This section should include the following: Screening/Enrollment Log - subjects who were enrolled,

screened, screen failed, withdrawn, and completed the study. Note that per health system policy, subjects are considered “enrolled” when they sign consent.

Subject Identification Log If these documents are maintained elsewhere (such as electronically), please indicate the location in the table below:

Document Location

This section is required

Consent Form

This section should include: The most recent IRB approved stamped consent form(s) Older IRB approved versions - This is optional only if

these versions are contained within the IRB correspondence section

Consent forms should be stored in reverse chronological order with the current approved version first. **We suggest that the most recently approved consent be placed in a clear plastic sleeve so it is easily distinguished** Note: Any changes to the consent form must be submitted to and approved by the IRB prior to use. If the consent forms are maintained elsewhere (such as electronically), please indicate the location below:

________________________________________________.

Using the Short Form for Subjects with Limited English Proficiency

If you do not anticipate enrolling subjects who are not fluent in English and there is no translated consent form available, please follow the IRB and health system’s policy on the use of short forms to obtain consent and documentation requirements. If you anticipate enrolling non-English proficient populations you should have translated consent forms available.

Short Forms available online at: www.nslij.com/irb in the following languages:

The English version is also available

Albanian French Creole Portuguese

Arabic Greek Russian

Chinese Hindi Spanish

Chinese (Traditional)

Italian Tagalog

Dutch Korean Urdu

Farsi Polish Vietnamese

French Japanese Bengali

Croatian

Other short form translations will be added as needed.

When using a short form please type the study related information onto the form, rather than handwriting it.

This section is required

Completed Signed Consent Forms Place all original signed consent forms in this section (however, this may depend on sponsor requirements). For studies that enroll many subjects, consents can be kept in a separate binder with a note to file in this section referencing the location of the separate binder. Note: For subjects who signed the consent form and later withdrew, the consent form must still be kept. A note to file should be written and filed explaining the withdrawal. This note can be placed with the consent form.

If completed consent forms are maintained elsewhere (such as in a separate binder) please indicate the location below:

________________________________________________.

This section is required

Protocol

This section should include: The most recent IRB approved protocol Older IRB approved versions –This is optional only if

these versions are contained within the IRB correspondence section.

Note: Any changes to the protocol must be submitted to and approved by the IRB prior to implementation. If the protocol(s) are maintained elsewhere, please indicate the location below:

________________________________________________.

This section is required

IRB Federal-Wide Assurance Letter

IRB Federal-Wide Assurance Letter is maintained elsewhere; the location is identified below:

________________________________________________.

This section is required

Initial IRB Approval

Please document and maintain all relevant correspondence related to the initial IRB approval of the study in this section. This section should include copies of: Original IRB application/submission IRB review response to PI PI response to IRB IRB approval letters (contingent approval and final) All relevant IRB correspondence (including emails) Note: If you are missing any of the above documents, you can obtain a copy from the Office of the IRB. If initial IRB approval documentation is maintained elsewhere, please indicate the location below:

________________________________________________.

This section is required

IRB Correspondence Please document and maintain all relevant correspondence with the IRB in this section (other than the initial IRB submission, which has its own section). This section should include: IRB approval letters Relevant IRB correspondence (including emails) Modifications Progress reports Any other documents submitted to the IRB (e.g. DSMB reports) (unless they are located in a separate section) Documents should be stored in reverse chronological order with the most current documents first. The IRB approval letter must be placed on top of accompanying forms and correspondence as a packet. If you are missing any of the above documents, you can obtain a copy from the Office of the IRB. Note: If you are the coordinating site, you should retain a copy of the other participating sites’ IRB approvals.

If relevant IRB correspondence is maintained elsewhere, please indicate the location below:

________________________________________________.

This section is required

Study Termination If your research study is being terminated or if the PI is leaving and the study will no longer be continued, the IRB Termination form needs to be completed. This section should include: A copy of the Study Termination Report IRB termination acknowledgement letter If study termination documentation is maintained elsewhere, please indicate the location below:

________________________________________________.

Note: If the PI is leaving the health system, the final evaluation of financial and grant related aspects, regulatory approvals, study data and materials, and equipment associated with research projects should be performed. Proper arrangements must be made for the appropriate transfer, disposal, decontamination, or archival of research project data and materials or equipment. All investigator exit processes and procedures should be completed prior to the PI’s last date of employment. See HS Research PI Exit Policy GR088 for more detailed

instructions and information

This section is required

Reportable Events

(e.g. Unanticipated Problems/ Protocol Deviations/ SAEs)

& Protocol Exceptions

This section should include copies of: IRB acknowledgements or approvals, Relevant correspondence, Reportable Event and Protocol Exception Forms and any attachments submitted to the IRB **Some sponsor approved exceptions may need to be approved by the IRB prior to implementation** Documents should be stored in reverse chronological order with the most current documents first. Note: Please review the HRPP policy on when to report certain events. Reportable events include unanticipated problems, SAEs and protocol deviations. Unanticipated problems are: 1) unexpected, 2) related/possibly related, and 3) may cause risk of harm to the subject or others.

If the above documents are maintained elsewhere, please indicate the location below:

Reminder: Certain reportable events may require reporting to your facility Quality Management Department. Speak with your facility/department quality management staff to determine the appropriate reporting process.

Document Location

See the Requirements for Registration of Clinical Research Studies Policy on HealthPort for more detailed information

Complete this section only if it applies to your study

Public Registration of Research Studies

Clinicaltrials.gov Identifier: NCT ______________

Place the registration receipt in this section for initial registration and for any updates.

The registration receipts are maintained elsewhere; the location is indicated below:

_________________________________________________________________

Does My Study Need to Be Registered? Please note that some research studies that are not typically called a “clinical trial” may still need to be registered All applicable clinical trials should be registered at www.clinicaltrials.gov as per the International Committee of Medical Journal Editors (ICMJE), the FDA Amendments Act of 2007, and Health System policy. • Applicable Clinical Trial – generally includes controlled interventional studies (with one or more

arms) or drugs, biological products, or devices that are subject to FDA regulation, meaning that the trial has one or more sites in the United States, involves, a drug, biologic, or device that is manufactured in the United States (or its territories), or is conducted under an investigational new drug application (IND) or investigational device exemption (IDE).

Trial sponsors and investigators have the responsibility of determining whether or not a trial is an “applicable clinical trial.” You should err on the side of registration if you are uncertain whether your trial meets the definition if you wish to seek publication in an ICMJE journal. Who Registers? The PI is responsible for ensuring that registration requirements are met. Even though some sponsors will do the actual registration work for the PIs, it is still the PI’s responsibility to ensure that the registration has been accomplished. Normally, the clinical trial will be registered by the sponsor or lead PI, in the following situations:

• Industry-sponsored trials (industry-written protocol) should normally be registered by the industry sponsor.

• Multi-site trials should be coordinated among the sites and registered by the “lead sponsor or lead PI” so that ClinicalTrials.gov does not receive multiple registrations for the same trial.

• NIH-sponsored trials may be registered by the Institute that is funding the research. However, some trials will need to be registered by the PI.

• Investigator-initiated trials (for which industry has supplied drug or grant funds) should normally be registered by the PI.

• Trials for which PIs hold their own Investigational New Drug Applications (INDs) or Investigational Device Exemptions (IDEs) should normally be registered by the PI. (PIs who hold their own INDs or IDEs are considered to be the trial sponsors.)

• Trials that the sponsor has declined to register.

See the Requirements for Registration of Clinical Research Studies Policy on HealthPort for more detailed information

How to register?

1. Send an email message to: irb@nshs.edu with the subject line: ClinicalTrials.gov 2. Include in the message your name, department, telephone number, and email address. 3. You will receive an email from Clinicaltrials.gov with a login name and temporary password.

Save your password - you will need it for periodic updates and verification (see below). 4. Go to the Clinicaltrials.gov Registration Web site. 5. Complete the login fields. In the “Organization” field, enter “northshore.” 6. Browse the Main Menu page. Under “User Account,” follow the instructions for changing your

temporary password as soon as possible. Refer to the “User’s Guide” for additional information. As the PI, you are a “user,” and you are responsible for entering the information about your trial, ensuring that the information is correct, and updating the information in a timely manner.

7. On the Main Menu page, under Protocol Record hit “Create” and complete the study description template. Note that the ICMJE/WHO-required fields are marked with a green “WHO” and the ClinicalTrials.gov-required fields are marked with a red asterisk (*). Taken together, these data elements represent the requirements for an adequate registration. Complete the fields as follows: • Organization’s Unique Protocol ID: Use the protocol’s IRB number. • Oversight Authorities: If this is not an FDA-regulated protocol, state “United States: IRB” • Sponsor: Allow the database to default to “North Shore-LIJ Health System” (although

NSLIJHS is not actually the trial’s sponsor). • Collaborators: Sponsorship can be clarified by entering the actual sponsor’s name as an

“agency.” For example, if this is an investigator-initiated clinical trial and you (the PI) hold the IND/IDE, list yourself.

• Record Verification Date: Enter the date on which you complete and submit the template. • Last Follow-Up Date: When creating the template, specify the anticipated last follow-up

date. • Conditions: Use the MeSH controlled vocabulary (provided). If you don’t, ClinicalTrials.gov

staff are likely to delete your term and choose one of their own. • Keywords: Use the MeSH controlled vocabulary (provided). If you don’t, ClinicalTrials.gov

staff are likely to delete your term and choose one of their own. 8. If the PI did not personally complete the template, send the draft template to him/her for review

and approval. Note: This is an important step. 9. Submit the completed, PI-approved, template. The completed template will go to the Offices of

Research Compliance and the IRB. Records will be checked to be sure that the trial has been approved by the IRB and once approved will be released to ClinicalTrials.gov.

10. Once you receive confirmation, download a copy of the registration and place with your study’s critical documents (i.e. Regulatory Binder).

11. If the study is federally funded, provide a copy of the registration to the Grants Management Office to ensure execution of any required agreements and/or sub-contracts.

How to transfer Clinicaltrials.gov registration: to transfer the registration to another institution contact clinicaltrials.gov and the institutional administrator to facilitate transfer.

Complete this section only if it applies to your study

Advertising/Educational Materials

This section should include: Any IRB approved advertisements or recruitment flyers Any IRB approved written educational or other

materials provided to study participants Documents should be stored in reverse chronological

order with the most current documents first Note: For marketing materials used to recruit through mass media (e.g. newspaper, television, radio, some internet postings, etc.) you must contact the NSLIJ Health System Marketing Department to ensure logo/branding is appropriate If the advertising/educational materials are maintained elsewhere, please indicate the location below:

Document Location

Complete this section only if it applies to your study

Sample Tracking and Shipping

This section should include: A central or master log that allows tracking of all research

study sample collection, shipment (or transport), and storage Shipping receipts Packing and shipping training certification (from Saf-T Pak or

other approved equivalent program) **You must be able to track the chain of custody for all samples** Note: All biological and hazardous materials (including dry ice) must be handled, stored, and shipped in compliance with FAA, IATA, and other applicable regulations as well as Health System policies.

If the sample tracking and shipping or certification information is maintained elsewhere, please indicate the location below:

Document Location

Complete this section only if it applies to your study

Local Lab Certificates/

Reference Ranges

For every laboratory utilized in your study that will be performing specimen testing in which results are validated (not experimental), place a copy of the most updated:

Lab certificate(s) and reference ranges Lab director’s CV

For studies that use NSLIJ Health System Laboratories, labs’ certificates, director’s CV and references ranges are available on line through the www.nslij.com/irb regulatory binder section. For any questions, please contact the specific lab.

Note: Lab tests used to inform participants or their healthcare providers to alter care must be performed in a CLIA certified lab, or if in NY, by a NYS Dept. of Health certified lab.

If lab information is maintained elsewhere, please indicate the location below:

Document Location

Complete this section only if it applies to your study

Investigational Product Information

For studies that involve investigational products (e.g. drugs, biologics, or devices), this section should include any of the following: Investigator’s brochure(s) (IB) or equivalent information for investigational products Product information and package insert or equivalent for approved medications Device information sheet Documents should be stored in reverse chronological order with the most current version first.

The above document(s) are maintained elsewhere; the location is identified in the table below:

Document Location

Investigator’s brochure(s) (IB) Product information and package insert Device information sheet Other, specify: Other, specify:

Complete this section only if it applies to your study

Sponsor Correspondence

Please document and maintain all relevant correspondence with the sponsor in this section.

If relevant sponsor correspondence is maintained elsewhere; the location is identified below:

________________________________________________.

Complete this section only if it applies to your study

FDA Forms and Correspondence

This section should include documents/ forms used when the study involves an investigational drug or device, such as: FDA Form 1572 - when the study involves an

investigational drug FDA Form 1571 - for investigator initiated INDs. FDA Form 3541 - Premarket Notification [510(K)] Status

Request and Response Investigational Device Exemption (IDE) application Premarket Approval (PMA) application Any other relevant FDA documents and correspondence

FDA forms, instructions and guidance are available online at www.fda.gov If FDA documents are maintained elsewhere, please indicate the location below:

Documents Location

Complete this section only if it applies to your study

Other Relevant Study Documents

Place other important study documents in this section. This can include:

Certificates of Confidentiality Literature or publications Reviewing committee correspondence and approvals Other general correspondence Other, specify: _________________________________ Other, specify: _________________________________ Other, specify: _________________________________

Helpful Tools

We highly recommend using the tools in the following section to assist with the informed consent process, organizing your research study, or for quality improvement purposes.

Sample Enrollment & Eligibility Checklists

This section include the following checklists: Sample Enrollment Note and Checklist

Enrollment notes should be written to document the consent process for each subject and signed and dated by the person obtaining consent prior to any study related procedures and activities. An enrollment note checklist can be used to document this process. Please note that the NS-LIJ health system IRB considers a research subject enrolled on the study once the informed consent process has been completed properly. The definition of “enrolled” may be different between the health system and sponsors)

Sample Eligibility Checklist

Use this checklist to confirm that each subject meets eligibility criteria based on the inclusion/exclusion criteria detailed in the IRB approved protocol.

Enrollment Notes

Investigators should create enrollment notes when enrolling subjects into their study to document the consent process. Study specific templates can be created and used by investigators. On subsequent visits, you should document the subject’s willingness to continue with the study. The enrollment note should include the following: • Date/time the note is written • Identify the protocol the subject is being enrolled into • Statement that the subject meets inclusion criteria and does not meet any of the exclusion

criteria • Statement that informed consent (or assent) was obtained prior to any study procedures

being performed • Statement that the subject/legal representative was given an opportunity to ask questions • Statement that the subject was given a copy of the signed consent form • Other pertinent information (e.g. contact information of research staff given to subject,

documentation of baseline procedures performed per protocol, quiz completion notes, assent notes, etc.)

• Signature and date of IRB approved investigator If applicable: • Statement of capacity or statement regarding why consent of a LAR was obtained and

why that individual had the authority to act on behalf of the subject • For subjects with limited English proficiency, statement on who translated the consent,

use of the short form, and other consent procedures Subject Enrollment Note (Sample)

Date: 5/5/10, 10AM Protocol: Test Trial Subject initial: A-B Study ID#: 131 Subject #131 met all the inclusion criteria and did not meet any exclusion criteria for the Test Trial and was enrolled on 5/5/10. The study was explained; the subject had an opportunity to ask questions, and was given a signed copy of the consent form. Consent was obtained prior to the start of any study procedures. (For women of child bearing potential) The procedures listed in the consent with regard to pregnancy were reviewed with the subject. The subject agreed to continue abstinence or a medically accepted method of birth control as defined in the consent for the entire study. The subject was informed to notify the study doctor immediately if she suspects she has become pregnant. A laboratory specimen for screening was drawn and shipped to the West Lab as per protocol. Physical exam by Dr. Smith Past Medical History: <include all medical and surgical history> Current medications: <include name, dose, frequency, indication, and date started> Next study visit is 5/10/10 at 10am. <Signature and date of Investigator>

Self-Audit Tools

All NS-LIJ Health System IRB approved studies are subject to routine audits by the Office of Research Compliance and may also be reviewed by external agencies such as the study sponsor or government agencies. We recommend that sites perform self-assessments on a regular basis and prior to audits. Quality improvement tools in this section include: Informed Consent Self-Audit Checklist Good Clinical Practice (GCP) Self-Assessment Checklist Corrective and Preventive Action (CAPA) Plan Template

Study Tools and Templates You can modify these tools and templates to fit your study. Use notes sheets to document the progress of study participants or to clarify any information related to your study. Included in this section: Templates: Note to File Subject Eligibility Confirmation Checklist Progress Notes Register of Archived Research Data & Records Logs: Telephone Log Study Adverse Events Log Investigational Drug/Biologic Accountability Record Investigational Device Accountability Log Temperature Log