Module 1: Orientation to the UWCCC - Federated … · Module 1: Orientation to the UWCCC ... research nurses and regulatory specialists . ... case report forms

Module 1: Orientation to the UWCCC

UWCCC Clinical Research Training Course

Shari Zeldin, BS, CCRC UWCCC Clinical Research Compliance Office

Compliance and Training Officer

Mission: To reduce the burden of cancer by advancing methods of treatment, diagnosis and prevention Goals: To conduct research of the highest quality into the origins and

control of cancer

To translate research findings to evaluation in the clinic through well designed clinical trials with corresponding biologic endpoints

To provide the best care possible to all cancer patients by carefully integrating high quality cutting edge care with clinical research in a compassionate and individualized manner

Mission and Goals

History of the UWCCC

1935 Harold P. Rusch led the establishment of a UW cancer research program

1940 Dr. Rusch appointed first Director of McArdle Laboratory

1973 UW one of six institutions awarded CCSG as an NCI-designated comprehensive cancer center

1978 Paul P. Carbone named Director

1994 Process started to consolidate the two UW cancer centers

1997 John Niederhuber named Director

2001 Submission of first consolidated CCSG

2002 George Wilding named Director

2008-13 WIMR 1 & 2 & WID/MIR completed/occupied

2013 Howard Baily named Interim Director

Harold Rusch, M.D. Paul P. Carbone, M.D.

What does it mean to be Comprehensive Cancer Center?

UWCCC Scientific Programs The scientific mission of the UW Carbone Cancer Center (UWCCC) is organized around eight Scientific Programs.

• Cancer Control (CC)

• Cancer Genetics (GN)

• Cell Signaling (CS)

• Chemoprevention (CP)

• Experimental Therapeutics (XT)

• Human Cancer Virology (VR)

• Imaging and Radiation Sciences (IR)

• Tumor Microenvironment (TM

UWCCC Multidisciplinary Team Approach

UWCCC Shared Services

• There are 16 Shared Services which play a vital role in facilitating research at the UWCCC

• Utilized by UWCCC members, research programs, focus groups, and the Disease Oriented Working Groups (DOWGs)

• Provide access to technologies and services that

enhance scientific interaction and productivity

• Primary users are cancer center members with peer-reviewed funded projects


• Analytical Lab (3P)– provides accurate and efficient state-of-the-art data and analyses of pharmacogenetic, pharmacodynamic, and pharmacokinetic parameters. The 3P Lab has 4 services available:

1. Sample Acquisition Services 2. Analytical Services 3. Equipment 4. Preclinical Therapeutics

• Biostatistics- provides statistical support in the design, conduct and analysis of basic, clinical and population-based sciences research. Biostatistics offers a drop-in clinic for UWCCC members.

• Cancer Informatics- provides informatics intellectual resources, including clinical and bioinformatics, image analysis and computational biology

• Clinical Imaging- facilitates the incorporation of clinical imaging into UWCCC clinical trials and acts as a liaison between the Cancer Center and the Department of Radiology

• Clinical Research Central Office (CRO)- provides the infrastructure to support the clinical research at the UWCCC


• Experimental Pathology- provides histology services to UWCCC members

• Flow Cytometry- provides a flow cytometry facility dedicated to the research needs of UWCCC members

• Glasswashing and Sterilization- provides centralized services for cleaning and sterilizing laboratory glassware and media

• Pharmaceutical Research Center (PRC)- ensures the safe and ethical provision of investigational/study drugs to research subjects enrolled in clinical drug trials within the UWCCC

• Proteomics- provides access to state-of-the-art mass spectrometry and gel electrophoresis instrumentation for proteomic and metabolomics research

• Scientific Instrumentation Facility- maintains an inventory of scientific

equipment and usage, and facilitates the enforcement of UWCCC security, safety and space management policies


• Small Molecular Screening- works collaboratively to identify new small

molecular agents that inhibit cancer phenotypes in cellular and animal models that can be further developed for clinical evaluation in human cancer patients

• Small Animal Imaging- provides innovative, non-invasive, high resolution imaging support to UWCCC members

• Survey Research- promotes cancer-control research through assistance in designing and implementing cancer-related surveys

• Transgenic and Mutant Animals- provides access to transgenic and genetically-engineered mutant animals for unraveling the molecular and genetic mechanisms of cancer and for evaluating new strategies for treatment and prevention studies

• Translational Science BioCore- provides a prospective collection and

storage of residual human tissue, blood, and other biospecimens to be used in future research studies

UWCCC Organizational Structure


DOWGs/ CRGs

Disease Oriented Working Groups (DOWG) & Clinical Research Groups (CRG) DOWG/CRG (Scientific Program) Leader(s) Program Manager

Brain (XT) Dr. John Kuo Diana Trask

Breast ( XT) Dr. Mark Burkard/ Dr. Lee Wilke Tammy Koehn

Chemoprevention (CP) Dr. Howard Bailey TBA

Gastrointestinal- GI (XT) Dr. Noelle LoConte/ Dr. Clifford Cho Rachel Crawford

Genitourinary- GU ( XT) Dr. Glenn Liu/ Dr. David Jarrard Mary Jane Staab

Gynecological (XT) Dr. Lisa Barriolhet Sarah Stewart

Head and Neck (XT) Dr. Paul Harari Diana Trask

Lung –Thoracic (XT) Dr. Anne Traynor TBA

Lymphoma (XT) Dr. Brad Kahl Elaine Paterson

Melanoma (XT) Dr. Mark Albertini Jennifer Collins

Palliative Care (CC) Dr. James Cleary/ Dr. Toby Campbell Renae Quale

Pediatric Oncology (XT) Dr. Kenneth DeSantes Jenny Weiland

Cancer Therapy Discovery and Development -CTD2 (XT) Dr. Glenn Liu/ Dr. George Wilding Jennifer Heideman

Skin/Non-melanoma (XT) Dr. Gary Wood Diane Bock

Translational Imaging Research Working Group (IR) Dr. Robert Jeraj Office for Translational Research Services (OTRS)

What is a DOWG?

• A DOWG is composed of clinical, translational and basic researchers and research staff focused on performing cancer related clinical research focused on prevention, diagnosis and treatment of disease specific areas of cancer

• Each DOWG provides administrative, regulatory, fiscal and clinical oversight for the facilitation and conduct of clinical research within their disease-specific research group

• The DOWG infrastructure includes: • Designated Leader

• Research Program Manager

• Clinical and laboratory faculty (MDs) and staff

• Study coordinators, research nurses and regulatory specialists

DOWG Roles and Responsibilities:

DOWG Leader

Reports to the UWCCC Associate Director for Clinical Research for all DOWG-related matters

Assures that all DOWG-related clinical research adheres to Federal, University of Wisconsin, and UWCCC policies, procedures and requirements

Reviews and assures that all DOWG-related research has the necessary support to be performed safely and efficiently

Prioritizes clinical research resources within the DOWG

Develops and implements a research strategic plan for the DOWG that interacts with UWCCC scientific programs

Meets the educational requirements set forth by the UWCCC as well as the educational goals of the DOWG

Provides a signature for all of the DOWG’s cancer- related clinical research protocols submitted to the UWCCC Protocol Review and Monitoring Committee (PRMC) to assure that their responsibilities in reviewing the proposed research have been met


Clinical and laboratory faculty (MDs) and staff

Assures that all DOWG-related research adheres to Federal, UW, and UWCCC policies, procedures and requirements

Focuses on investigations pertinent to the research group

Participates in establishing clinical and translational research goals within the DOWG

Works with the DOWG leader to achieve the goals and responsibilities of the DOWG

Generates, discusses and prioritizes research ideas within the DOWG

Meets the educational requirements set forth by the UWCCC as well as the educational goals of the DOWG


Research Program Manager (PM)

Assures that all DOWG-related clinical research activities adheres to Federal, UW, and UWCCC policies, procedures and requirements

Develops, manages, implements and oversees DOWG clinical research activities

With the DOWG Leader, determines and oversees the clinical research staff (study coordinators / regulatory specialists) required to carry out the activities

Works with the UWCCC Assistant Director of Clinical Research and the Clinical Research Coordinating Office (CRCO) to accomplish the goals of the DOWG

Manages fiscal activities, including allocation of study funds and resources, develops budgets and monitors expenditures

Develops, executes and manages agreements with external sponsors and regulatory agencies

Assures that the educational requirements set forth by the UWCCC are met by themselves and their research support staff


Study Coordinators/ Research Nurses/Regulatory Specialists • Adheres to Federal, UW, and UWCCC policies, procedures and

requirements for clinical research activities

• Works under the direction of the Research Program Manager

• May be licensed personnel • Clinical Research Nurses and Nurse Practitioners can perform clinical

research activities that are within the scope of their practice

• Referred to as Clinical Research Associates (CRA) or Clinical Research Coordinators (CRC)

• Carry out the regulatory and clinical functions of the study including, but not limited to; site preparation, subject screening, consenting and enrollment/registration, study visit conduction, study preparation and maintenance, completion and maintenance of IRB, regulatory and source documents, adverse event reporting, completion of and data recorded on case report forms (paper or electronic), and submission of data into OnCore database

Clinical Research Leaders

Program Manager

Committee

Protocol Review and Monitoring Committee

(PRMC)

UWCCC LEADERSHIP

Data and Safety Monitoring Committee

(DSMC)

Biostatistics Shared Resource

Cancer Informatics Shared Resource

Clinical Research

Committee (CRC)

Clinical Research Infrastructure

DOWGs/ CRGs

Clinical Research Central Office

(CRCO)

ONCOR E


Program Manager

Committee


(PRMC)

UWCCC LEADERSHIP


(DSMC)



Clinical Research

Committee (CRC)


DOWGs/ CRGs


(CRCO)

ONCOR E

UWCCC Clinical Research Infrastructure:

Clinical Research Committee (CRC) • Comprised of UWCCC senior administrative and DOWG leadership

• Meets monthly to discuss issues pertinent to the UWCCC clinical research enterprise

• Sets UWCCC policy and procedures, and oversees all aspects of clinical research conducted at the UWCCC and by UWCCC faculty at outreach sites

• Appoints membership and defines responsibility of Protocol Review and Monitoring Committee (PRMC) and Data and Safety Monitoring Committee (DSMC)


Program Manager

Committee


(PRMC)

UWCCC LEADERSHIP


(DSMC)



Clinical Research

Committee (CRC)


DOWGs/ CRGs


(CRCO)

ONCOR E


Protocol Review and Monitoring Committee (PRMC)

• Required by the NCI- Scientific Review Committee

• Responsible for the scientific review, resource allocation and prioritization of all new and ongoing clinical research protocols

• Reviews all cancer-related clinical research for UW Conflict of Interest (COI) compliance

• Assures appropriate data and safety monitoring plan is included in each protocol submission

• Reviews all ongoing clinical trials for scientific progress in meeting accrual goals

• Closes studies for insufficient progress or new prioritization considerations


Program Manager

Committee


(PRMC)

UWCCC LEADERSHIP


(DSMC)



Clinical Research

Committee (CRC)


DOWGs/ CRGs


(CRCO)

ONCOR E


Data and Safety Monitoring Committee (DSMC) • The UWCCC Data and Safety Monitoring Plan (DSMP) outlines the policies

and procedures for data and safety oversight of clinical research at the UWCCC

• The DSMC is the data and safety monitoring oversight body for the UWCCC

• Responsible for the regular review and monitoring all on-going clinical research at the UWCCC and affiliate sites for safety and data quality issues

• Meets every other month to review safety and data quality reports including internal audits, quality assurance reviews, response reviews, protocol deviations and serious adverse events (SAE)

• Reviews all SAE reporting in real time via the DSMC Chair

• Reviews Protocol Summary Reports for all open-to-accrual studies

• Reports directly to the CRC regarding individual protocol issues

• Regulatory will send quarterly or annual DSMC reports


Program Manager

Committee


(PRMC)

UWCCC LEADERSHIP


(DSMC)



Clinical Research

Committee (CRC)


DOWGs/ CRGs


(CRCO)

ONCOR E


DOWGs/ CRGs

CRCO

Assistant Director of Clinical

Research

Katie Wulff

Clinical Research

Central Office

Services Office

Operations Manager- Hilary

Hernan

Affiliate

Outreach

Network

-WON

-NCTN

Shared

Regulatory

Budgetary

Compliance

Clinical

Research

Training

and

Education

Clinical Trials

Reporting

Program

(CTRP)/

ClinicalTrials.gov

Protocol

Review and

Monitoring

System

- PRMC

Compliance Office

Compliance Manager- Shari

Zeldin

Interim Assoc. Director of

Administration

Patti Mulcahy

Associate Director of Clinical

Research

Brad Kahl, MD

Interim Director

Howard Bailey, MD

UWCCC Clinical Research Program

1 S. Park

Clinic

Oversight

Data and

Safety

Monitoring

System

-DSMC

-Auditing &

Monitoring

UWCCC Clinical Research Central Office:

Compliance Office Provides all areas of compliance, oversight and monitoring for the clinical research infrastructure of the UWCCC • Data and Safety Monitoring

• External Audits, • Internal Audits (IA) and Quality Assurance Reviews (QAR) • DSMC meeting coordination

• Training and Education • Clinical Research Training Course • Ad Hoc Training and monthly educational sessions • Continuing Education

• Protocol Registration Compliance

• CTRP and ClinicalTrials.gov protocol registration

• Affiliate/Outreach Network • Coordinates clinical research conducted at affiliate sites • Oversee and manages Wisconsin Oncology Network (WON) and other

affiliations (cooperative groups)

Affiliate/ Outreach Network Cont.

• Regulatory and compliance oversight and management of Affiliate (external) sites

• Consists of sites across the state and region that participate in clinical research through collaborations with the UWCCC

• These site affiliations are managed and facilitated by the Affiliate Coordinators in the CRCO

• Sites are affiliated with the UWCCC through one or more of the following mechanisms:

• Wisconsin Oncology Network (WON)

• UWCCC Regional Partners (RPs)

• National Cooperative Group Affiliations

Affiliate/Outreach Network: Wisconsin Oncology Network (WON)

• In 1998, WON was established to allow community health centers to participate in IITs (written and sponsored by UWCCC Investigators) developed at the UWCCC

• Since its inception, WON has expanded to over 20 sites throughout Wisconsin, and surrounding regions in Illinois (Freeport) and South Dakota (Rapid City)

• WON Co-Chairs: Drs. Kari Wisinski and Ryan Mattison

• The UWCCC is responsible for auditing WON sites once per year (remotely) and every three years in-person

• Monthly Conference Calls

• Bi-Annual Meeting

• External site data verification in OnCore

Wisconsin Oncology Network (WON)

Affiliate/Outreach Network:

Regional Partners (RP)

UWCCC and UW Hospital have established affiliation agreements with regional hospitals and cancer centers, extending the availability of state-of-the-art cancer programs and clinical research opportunities to:

• Beloit Memorial Hospital in Beloit, WI • L.C. Ferguson Cancer Center in Freeport, IL • UWCC-Riverview in Wisconsin Rapids, WI • UWCCC- Swedish American, Rockford, IL • UWCC-Johnson Creek in Johnson Creek, WI*

*UWCC-Johnson Creek only participates in cooperative group studies that are open at the UWCCC; the DOWG retains all regulatory responsibilities for those studies and adds Johnson Creek to the consent form. The remaining regional partner sites complete their own regulatory submissions and may participate in cooperative group studies that are not open at the UWCCC.

NCI Cooperative Group Program

The National Cancer Institute (NCI) has supported the National Clinical Trials Cooperative Group Program for over 50 years to conduct large-scale, clinical treatment trials across the nation. The Group Program successfully completed many important trials that led to new treatments for cancer patients. • ECOG- Eastern Cooperative Oncology Group

• COG- Children’s Oncology Group is a NCI-supported clinical trials cooperative

group devoted to childhood cancer research

• GOG- Gynecologic Oncology Group is one of the NCI’s funded cooperative cancer research groups devoted solely to gynecologic cancer research

• CALGB- Cancer and Leukemia Group B

• NSABP- National Surgical Adjuvant Breast and Bowel Project

• SWOG- Southwestern Oncology group’s primary mission is clinical research in the prevention and cure of cancer

• ACOSOG- American College of Surgeons Oncology Group focusing on evaluating the surgical management of patients with malignant solid tumors

• RTOG- Radiation Therapy Oncology Group

• NCCTG- North Central Cancer Treatment Group

• ACRIN- American College of Radiology Imaging Network

NCI National Clinical Trials Network (NCTN)

• In an effort to promote efficiency and promote system integration, the previous NCI-sponsored Clinical Trials Cooperative Group Program was transformed into a consolidated and integrated program now referred to as the NCI National Clinical Trials Network (NCTN)

• The Cooperative Groups that make up the NCTN are now consolidated into 5 distinct groups:

• ECOG/ACRIN- ECOG, ACRIN • NRG- NSABP, RTOG, GOG • Alliance- CALGB, ACOSOG, NCCTG • COG • SWOG

• 1 S. Park participates as a UWCCC study site in clinical research studies open at UWCCC

• It is a multi-disease oncology clinic that provides clinical care and clinical research participation opportunities to its patients

• Sandra Black is the Study Coordinator

• Drs. Hei, Hegeman, Huie, and Stella are the faculty physicians

• The DOWG/CRG asks 1 S. Park whether they will participate in a given study- if so, they are added to the consent form as a participating site as well as all other regulatory documents

• The DOWG/CRG retains all regulatory responsibility for the study

* To distinguish from an “affiliate site”

Services Office: UWCCC 1 South Park Oncology Clinic: Study Site*

UWCCC Clinical Research Central Office:

Clinical Research Services Office

Provides clinical research services to the DOWGS/ CRGs

• Budget and Contract Services • Budget feasibility

• Research billing compliance

• Oncore Financials implementation and support

• Grants management

• Accrual reimbursements for cooperative group

• Shared Regulatory • Assists all DOWGs in regulatory work, including: • IRB submissions • Cooperative Group membership • Regulatory Staff Forum

• Continuing to grow!

UWCCC Internet Site:

http://www.uwccc.wisc.edu

Provides access to: • UWCCC contact lists and directories –main page • Physician CVs – CAP & CLIAs/CVs

• Checklist for new employees – SOPs/Forms/Documents > Administration

• Open Protocol List – SOPs/Forms/Documents > Regulatory

• Access to OnCore – OnCore Database

• UWCCC Standard Operating Procedures (SOP) and Guidance Documents – SOPs/Forms/Documents

• UWCCC-specific forms (e.g SAE routing form, PRMC submission form) – SOPs/Forms/Documents

• Affiliate Network information – SOPs/Forms/Documents

UWCCC Internet Site

http://www.uwccc.wisc.edu

UWCCC Internet Site : SOPs/Forms/Documents


UWCCC Clinical Research Database: Oncore

• Centralized database that manages all activities and captures all data related to clinical research conducted at the UWCCC

• HIPAA compliant and secured with individual user authentication and controlled data privileges

• Available via the internet to all UWCCC and affiliate research staff

http://www.uwccc.wisc.edu/content/oncore

• Generates annual reports for NCI regarding UWCCC clinical research productivity and subject accrual data

• Generates reports for all monitoring and auditing functions for the UWCCC


What is captured in Oncore?

ALL clinical research activities, including:

• Study setup and activation

• Protocol review and monitoring

• Protocol and regulatory tracking

• Subject registration, visit tracking, data collection

• BioSpecimen management

• Affiliate and outreach oversight

• Data and safety monitoring

• SAE reporting

• Study Staff

• Participating Institutions

UWCCC Internet Site: Oncore Database

UWCCC Internet Site

Oncore Data Field Definitions (DFDs)

OnCore Data Field Definitions (DFDs)

PC Console Main Details Tab

Clinical Research Infrastructure at UW- Madison: An Overview of Entities

Human Research Protection Program (HRPP)

• The Human Research Protection Program (HRPP) provides oversight of all research activities involving human subjects at the UW-Madison. HRPP is not an office, but rather a collective effort of all who participate in the conduct, review, approval and facilitation of all human subjects research at UW-Madison.

• The HRPP is staffed by the Office of Research Policy (ORP) and maintains the university’s policies governing human subjects research, which apply federal, state, and other regulatory requirements to all university faculty, staff, students, volunteers and research subjects.

• The HRPP policies address the review, approval and conduct of human subjects research at UW-Madison.

• The UW- Madison Institutional Review Boards (IRBs) are one of the largest components of the HRPP.

UW-Madison IRBs There are 3 campus IRBs: • Health Sciences (HS) IRB

• https://kb.wisc.edu/hsirbs/ • The HS IRB reviews research protocols involving medical interventions or

procedures where medical expertise is required for evaluation.

• Health Sciences Minimal Risk (MR) IRB • https://kb.wisc.edu/hsirbs/ • The MR IRB reviews primarily research protocols that present minimal risk to

subjects and that involve medical interventions or procedures requiring medical expertise or that require knowledge of the health care setting (e.g., medical records research, research database and tissue banking projects, survey and interview research, and exemption applications).

• Education and Social/Behavioral Sciences (ED/SBS) IRB • http://www.irb.wisc.edu/ • The ED/SBS IRB primarily reviews education, social, behavioral, and non-medical

health research. The ED/SBS IRB does review some minimal risk health-related studies (i.e. studies involving exercise, tape sensors, and single venipuncture) where medical training is not necessary to evaluate the risks to research participants.

https://kb.wisc.edu/hsirbs/




http://www.irb.wisc.edu/

Institutional Review Boards

• The primary function of an IRB is to protect the rights and welfare of human subjects

• Human subjects research cannot begin at UW-Madison without prior IRB approval or exemption of the study

• IRBs can require modifications to protocols in order for a research team to secure IRB approval

• IRBs can suspend or terminate research

Scientific Review Committees (SRC)-

• All studies submitted to the Health Sciences and Minimal Risk IRBs are required to undergo scientific review prior to IRB review. This requirement seeks to enhance the quality of health sciences protocols conducted at UW-Madison.

• There are 2 SRCs:

• UWCCC Protocol Review Monitoring Committee (PRMC)

• Reviews cancer-related studies

• UW Institute for Clinical and Translational Research (ICTR) SRC

• Reviews non-cancer research studies

Office of Research Policy (ORP)

Coordinates and facilitates research policy, ethics, and compliance activities for research conducted across the UW Madison campus. Major responsibilities include staff support and project development for the following committees and activities:

• Human Research Protection Program (HRPP)- discussed earlier

• Responsible Conduct of Research (RCR)

• Research Misconduct

• Outside Activities Report (OAR) and Conflict of Interest (COI) Committee

• Stem Cell Research Oversight (SCRO) Committee

Office of Research Policy (ORP): Responsible Conduct of Research (RCR) • An additional 8 hours of training focusing on Responsible

Conduct of Research (RCR) may be required for certain researchers, including, but not limited to those receiving NSF funding, training grants, certain NIH grants, and participating in US Department of Agriculture research.

• The specific training may vary based on the agency or department funding the research.

Office of Research Policy (ORP): Research Misconduct

• At UW-Madison, misconduct in scholarly research is defined as fabrication (making up data), falsification (changing or misreporting data), plagiarism (representing work of others as your own), or other practices that seriously deviate from those that are commonly accepted within the scholarly community for proposing, conducting, or reporting research.

• UW-Madison has adopted a federally-mandated three-phase process for investigating allegations of research misconduct (consisting of an inquiry phase, a Chancellor's review and a hearing phase) that is outlined in Faculty Policy II-314.

Office of Research Policy (ORP): Conflict of Interest (COI) and Outside Activities Reports (OAR) • The UW-Madison encourages faculty, staff, and students to engage

in outside activities and to share their knowledge and expertise.

• It acknowledges that potential financial conflicts of interest may result and are common, often unavoidable, and not necessarily problematic.

• UW-Madison has a Conflict of Interest (COI) Committee comprised of faculty members from across campus to review Outside Activity Reports (OAR) submitted by all faculty and academic staff for potential financial conflicts of interest.

• Prompt submission of OAR will help expedite any protocol submissions or grant proposals made before the next annual reporting period.

• COI policies, guidance and information on how to submit the OAR are located on the COI Program website.

Office of Research Policy (ORP): Stem Cell Research Oversight

• The Stem Cell Research Oversight (SCRO) committee provides oversight for all research on campus involving: the use of human embryonic stem cells (hESCs) or their derivatives; or the introduction of human pluripotent stem cells (hPSCs), or their derivatives, obtained from a non-embryonic source, into non-human animals at any embryonic, fetal, or postnatal stage, if an expected effect is that human cells will be integrated into the central nervous system, testes, or ovaries of the animal.

• There are separate training requirements for researchers involved in the types of stem cell research described above. The SCRO policies, guidance and training information are located on the SCRO website.

UW Health Policies : UW Hospital and Clinics (UWHC) and UW Medical Foundation (UWMF)

• UW Health provides an environment for the conduct of clinical research. Clinical research staff, the investigator and his/her team, are required to follow all UW Health policies and procedures when conducting research within UWHC or UWMF clinical space, in addition to following the Health Link Documentation Guidelines for research related activities/care. These policies apply to students, providers, volunteers, and staff.

• UW Health policies can be accessed through their internal webpage, UConnect (https://uconnect.wisc.edu) by clicking on the policies button in the navigator toolbar at the top of any UConnect webpage.

• Access to the UConnect website is restricted to those individuals who are named as part of the Affiliated Covered Entity (ACE) (i.e. UW School of Medicine and Public Health, UW-Madison School of Nursing, UW Hospital and Clinics, UW Medical Foundation).

https://uconnect.wisc.edu/

UWHC Policies that pertain to Clinical Research- A sampling: • Research Approvals:

• UWHC 12.10: Research Safety Committee (RSC) Authority & Function: Describes the additional review and approval that is necessary when a clinical (human) research study possessing potential health hazards are identified that could pose potential safety concerns to employees are not adequately covered by existing policies; this includes protocols involving gene therapy, infectious agents and other novel therapies.

• Access to and Use of Information and Data: • UWHC 1.02 Access to Electronic Information Systems • UWHC 1.49 Access to Enterprise Data for Analytics • UWHC 4.13 Using and Disclosing (or Releasing) Protected Health Information • UWHC 4.15 Videotape Recording and Patient Photographs • UWHC 4.34 Patient Rights and Responsibilities • UWHC 4.37 Approval to Practice at UWHC for RNs who are Non-UWHC Employees • UWHC 6.31 E-Mail Transmission of Protected Health Information (also refer to

equivalent MF e-mail policy)- See next slide for specifics!

UWHC 6.31 E-Mail Transmission of Protected Health Information

• This policy establishes processes for all employees and staff to utilize when communicating within UW Health or with outside healthcare providers about patients via e-mail (email correspondence with outside healthcare providers includes sending email to recipients with an addresses outside of “wisc.edu” or “uwhealth.org”).

• Don’t EVER include the patient name or MRN in the subject line

• As a general rule, Provider to Patient communications should be conducted through MyChart and not via e-mail. There are additional policies to be followed in the event that provider patient communication must occur via email (UWHC 6.32 Provider-Patient Email (UWMF equivalent policy MP 013)

More UWHC Policies that pertain to Clinical Research: • Clinical Research Studies involving Medications/Drugs: These policies describes

the Pharmaceutical Research Center (PRC) as the responsible party for coordinating and overseeing all clinical drug research conducted within UWHC facilities, regardless of FDA status.

• UWHC 10.0/10.1: Pharmaceutical Research Center (Goals and Objectives)

• UWHC 10.2 Pharmaceutical Research Center Initiation

• UWHC 10.4 Pharmaceutical Research Center Distribution of Research Drugs/Supplies

• UWHC 4.11 Investigational and Study Drug Control

• UWHC 4.27 Compassionate Use of an Investigational Agent or Use of an Investigational Agent from a second institution

More UWHC Policies that pertain to Clinical Research: • Research Staff Conduct:

• UWHC 1.30 Photo Identification Badge and Security Access System

• This policy describes the requirements for Photo ID. Badges must be worn by all UWHC employees, volunteers, vendors and service representatives, faculty (i.e., physicians, pharmacists, and nurses), and those using the institution for clinical experience or clinical research (e.g., students).

• UWHC 9.16 Health Dress Code and Appearance • This policy establish a dress code and appearance policy for employees who work in locations where clinical care

is provided, e.g. Clinical Sciences Center, American Family Children’s Hospital, outpatient clinics, etc. This policy outlines the minimum acceptable standard for dress and appearance.

• UWHC 11.19 Regulation of Vendor Representatives and the Vendor Liaison Office (this policy is used by UWHC, UWMF and UWSMPH).

• Also refer the UWHealth page with instructions for research personnel to register a vendor liaison: http://www.uwhealth.org/about-uwhealth/instructions-for-research-personnel/11109

• UWHC 13.08 Hand Hygiene • This policy describes the purpose and process to assure good hand hygiene that is important for patient and

personnel safety and is essential to good hygiene and cleanliness. Proper hand hygiene reduces the number of transient pathogens on the hands and reduces incidence of healthcare associated infections. Frequency of hand hygiene is determined by the nature of one's activities, length of procedure, and materials handled. Hand hygiene may be necessary multiple times during the care of a given patient.

• Remember, you can find these and more UW Health policies by accessing UConnect at https://uconnect.wisc.edu . Click on the policies button in the navigator toolbar at the top of any UConnect webpage.

http://www.uwhealth.org/about-uwhealth/instructions-for-research-personnel/11109









https://uconnect.wisc.edu/

Additional UW-Madison Entities that Clinical Research faculty and Staff should be aware of:

• Office of Research and Sponsored Programs (RSP)

• Office of Industrial Partnerships

• Institutional Biosafety Committee (IBC)

• Radioactive Drug Research Committee (RDRC)

• Radiation Safety

• Research Safety Committee

• Laboratory Safety

Office of Research and Sponsored Programs (RSP) • All research proposals, contracts, grants and cooperative agreements with

extramural sponsors must be routed to RSP. This includes This includes clinical trials, confidential/non-disclosure, research, material transfer, licensing/software/equipment, data sharing, and interagency personnel assignments along with any amendments, modification, and extensions to the above agreements.

• No contracts or agreements may be signed solely by the PI and cannot be finalized until reviewed and negotiated by the appropriate office, and signed by an authorized signatory of the University.

• Performs the final review of project proposals for UW Madison and transmits the proposals to sponsors of extramural support.

• Is the authorized signature authority, accepting awards on behalf of The Board of Regents.

• Responsible for negotiating language in the agreement/contract with sponsors, interpreting sponsor policy, and negotiating our indirect cost rate.

• Information on RSP’s policies and procedures can be found on their website (https://www.rsp.wisc.edu/)

https://www.rsp.wisc.edu/

Office of Industrial Partnerships (OIP)

• The Office of Industrial Partnerships (OIP) assists UW-Madison researchers in their partnerships with private industry. OIP is responsible for the institutional review of industry-sponsored research proposals.

• OIP also creates, negotiates, and finalizes the subsequent agreements and ensures that these collaborations remain consistent with the University’s mission

• The types of agreements handled by OIP include, but are not limited to, the following: memoranda of understanding, industry sponsored research, non-clinical trial related confidentiality or non-disclosure, all incoming and outgoing material transfer, all data use and all fee for service agreements.

Institutional Biosafety Committee (IBC) • The IBC is managed through the UW-Madison Office of Biological Safety

(OBS).

• The IBC reviews and approves all UW-Madison research involving the use of recombinant DNA and infectious agents (plant, animal and human)

Radioactive Drug Research Committee (RDRC) • Primary purpose is to review and oversee any clinical research study

involving radioactive drugs where no Investigational New Drug (IND) application is required.

• In addition to the initial protocol review and approval, the RDRC must review and approve all protocol amendments.

• Adverse events related to the radioactive drug must be reported to the RDRC.

• When RDRC review is required, RDRC approval must be obtained before the Health Sciences IRB will approve the protocol

Office of Radiation Safety

• The Office of Radiation Safety provides information and training for use of radiation emitting materials, devices, or instruments, and waste handling. This includes both ionizing radiation and non-ionizing (electromagnetic) radiation.

• Responsible for radiation safety training, provision of radioactive materials, dosimetry, radioactive waste handling, etc.

• All individuals authorized to use radionucleotides must be licensed and meet certain qualifications.

Research Safety Committee (RSC)

• The University of Wisconsin Hospital and Clinics (UWHC) Research Safety Committee (RSC) is a multidisciplinary committee whose purpose is to review research protocols that could pose potential safety concerns to employees are not adequately covered by existing policies; this includes protocols involving gene therapy, infectious agents and other novel therapies.

• Any clinical drug research protocol that requires Institutional Biosafety Committee approval will require submission and approval by the RSC. RSC approval is required before IRB approval may be issued. RSC approval is granted on a per protocol basis and NOT on a per agent basis.

Laboratory Safety • Many activities involving human subjects include activities conducted in a

laboratory setting or require staff to handle, process, and/or package and ship infectious substances and other biological materials. In this case there are additional training requirements to be met.

• Bloodborne Pathogens (BBP) (renamed Occupational Health 102) training is available online through Learn@UW. This training is made available by the Environment, Health & Safety Department, Occupational Health Office.

• Safety and Infection Control online training required for UWHC employees or SMPH staff/students that work in the UWHC facilities (UWHC, AFCH and/or UWHC Clinics) to complete annually. For all clinic and non-clinic staff.

• Training and certification on how to package, ship or otherwise transport biohazardous materials (HazMat) is provided online through Learn@UW. This training is made available through the Environment, Health & Safety Department, Office of Biological Saftey (OBS).

Depending on the scope of your research, laboratory safety resources and requirements vary. The Department of Environment, Health and Safety (EHS) has several units providing consultation services, training opportunities and compliance resources.

Additional Resources

• https://kb.wisc.edu/gsadminkb/page.php?id=34101-

Human Subjects Research Protection Program (HRPP) Policy Index

• https://kb.wisc.edu/gsadminkb/page.php?id=33364

The Research Checklist provides a thorough listing and helpful links and contact information for the oversight and administrative entities described above and more.

• https://kb.wisc.edu/gsadminkb/page.php?id=34045

Instructions for completing CITI Human Subjects Research Training

https://kb.wisc.edu/gsadminkb/page.php?id=34101






On to…….

Basic Concepts In Clinical Research!