Alyssa Speier, MS, CIP November 13, 2013 IRB Cheat Sheet: Tips and Tools for keeping our study organized and regulatory compliant Alyssa Speier, MS, CIP November 13, 2013 qip@hsph.harvard.edu www.hsph.harvard.edu/ohra/qip 1

Agenda ICH-GCP Guidelines QIP Regulatory Binder Participant Files Review of Contents/Sections Participant Files Record Retention Tips for Successful Record Keeping General Correction Do’s/Don’ts Electronic Record Keeping Questions & Additional Resources

ICH-GCP Guidelines International Conference on Harmonization (ICH)- Good Clinical Practice (GCP) International ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human participants Defines Essential Documents as those that “individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced” Demonstrates compliance Serves as best practice standard 3

QIP Regulatory Binder Based on GCP list of Essential Documents and OHRA’s Recordkeeping/Record Retention requirements Provides a template for maintaining and organizing documentation to ensure compliance with federal regulations, institutional policies and good clinical practice Alternatives exist: You can create your own way of organizing these documents that works best for you and your study team just BE CONSISTENT QIP provides record keeping recommendations and a regulatory binder based on best practices A study specific Binder will be provided based on the type of research being conducted (e.g., Social Behavioral, Biomedical, or FDA) 4

Binder Sections Overview (Essential Documents where applicable) All Studies: Protocol Staff CVs Staff Licensures Logs IRB Documents Consent Forms Data Collection Training Study-Specific: Lab Documents FDA Investigational Brochure Drug/Device Financial Disclosure NIH Sponsor DSMB Local Review 5

Essential Documents (All Studies) Section Purpose Considerations/ Recommendations Protocol Demonstrates investigator and/or sponsor agreement to the protocol. Highlights current study objectives and procedures. Ensure that the version number/date reflects the current protocol and/or Research Protocol. CVs and licensures Confirms staff qualifications to conduct a study or perform delegated tasks. CVs and licenses should be updated every 2 years to confirm that the information is accurate and current. Staff should sign and date CVs Maintain licensures for staff conducting clinical study related procedures

Essential Documents (All Studies) Section Purpose Considerations/ Recommendations Logs Assists with the collection of data that is required by or reported to the IRB or other regulatory authorities (e.g., Delegation of Responsibility Log) Information in logs can be customized to fit a specific study or added to existing electronic versions currently maintained on site. Template logs can be found here: http://www.hsph.harvard.edu/ohra/qip/study-management-tools/ IRB Documents Demonstrates that the IRB has reviewed and approved the study prior to initiation, continuing review, and protocol modifications and that reportable new information has been communicated to the IRB. File correspondence for a given submission in reverse chronological order to ensure an accurate timeline from study start-up to completion. Keep submissions, requires modifications, investigator’s responses and approvals together.

Essential Documents (All Studies) Section Purpose Considerations Informed Consent Documents that information is given to participants in a way that supports their ability to give informed consent. Maintains original copies of all IRB approved consent forms. Ensure that staff obtaining consent is using the most recently approved consent form (watermarked by ESTR at top of form and most recent approved version number/date) Data Collection Maintains original copies of all forms used to collect study data (e.g., case report forms or questionnaires/ surveys). Only blank copies of forms should be kept in regulatory file. Considerations for source documentation and data collection tools: Do not leave blank information (NA/ND/UNK).

Essential Documents (All Studies) Section Purpose Considerations Training Documents adequate training for all IRB approved personnel (e.g., CITI, protocol specific, or sponsor training). Maintains documentation of all training records and certifications. Any HSPH affiliate who is involved with human subjects activities (i.e., interactions/interventions with participants or access to identifiable data or specimens) must fulfill CITI training requirements every 3 years. Sponsor training requirements and timeframes may vary.

Study-Specific Documents Sponsored Financial Disclosure NIH Sponsor Data Monitoring DSMB International Local Review Tissue/blood Specimens Laboratory Documents Drug/Device FDA 1572 (drug) or Investigator Agreement (device) Investigational Brochure (drug) or Device Manual (device) Drug/Device Accountability IND/IDE Application 10

Study-Specific Documents: Laboratory Laboratory certification - review for expiration CAP/CLIA Lab Director’s CV Normal lab values/Reference ranges Note: Copies of laboratory documentation can be obtained from your sponsor or the clinical laboratory personnel 11

Study-Specific Documents: Drug/Device Sponsor-Investigator: Initial IND or IDE Application with 1571 Amendments to the Application Adverse Event Reports Annual Reports Clinical Investigator drug/device documents Clinical Investigator: 1572 (drug) or Investigator Agreement Investigator’s Brochure or Device Manual Drug/Device Accountability Log 12

NIH and Sponsor Documents NIH Documentation Copy of most recent progress report with enrollment table NIH grant application information Additional study correspondences with NIH Sponsor Documentation All ‘significant’ correspondences to and from the sponsor (e.g., letters, meeting minutes and telephone call notes) 13

DSMB Documentation Reports from DSMB meetings Additional correspondences with DSMB: E-mails Letters Meeting minutes

Local Review Local review is required for studies conducted abroad A copy of local ethical approval notice(s) For HHS-funded protocols: Review should be done by IRB of collaborating institution or another institution in geographical area Local IRB must be registered with OHRP and have FWA on file For non HHS-funded protocols: Review should be done by local ethical review board or community advisory board

Participant File Documents Documentation of Eligibility Documentation of Consent Data Collection Tools Note-to File Questionnaires Participant Diaries Demographics Form Medical History Form Physical Exam Form Lab Collection Form etc.

Participant Files Original signed and dated informed consent documents Completed data collection forms Source documentation Significant communication with participants 17

OHRA Record Retention Policy Maintain documentation at least 7 years from study closure date Check with sponsor to ensure compliance with their record retention policies 18

Tips for Successful Record Keeping Address and resolve documentation problems immediately Review documentation routinely Document and update materials in real time 19

Tips, continued… Study Record Corrections Do’s Make one line through the incorrect entry Retain readability of incorrect entry Write the corrected entry beside it Initial and date the correction Dont’s Use White-Out Obliterate an entry Use different color inks Sign the investigator’s or any other name 20

Tips, continued… Electronic Recordkeeping Maintain signed and dated note-to-file indicating the location of electronic correspondences. Ensure that electronic copies are available to study staff and regulatory authorities. Ensure privacy and confidentiality is maintained for participant files stored electronically. Maintain copies of documents and correspondences with the original signatures (pdf). 21

Questions? Quality Improvement Program Staff IRB Operations Staff Stanley Estime, sestime@hsph.harvard.edu, 617-432-2164 Lisa Gabel, lgabel@hsph.harvard.edu, 617-432-5842 Leslie Howes, lhowes@hsph.harvard.edu, 617-432-2153 Alyssa Speier, aspeier@hsph.harvard.edu, 617-432-2140 IRB Operations Staff Department Assigned IRB Review Specialist: http://www.hsph.harvard.edu/ohra/department-assignments/ Julie Kaberry (IRB Administrative Chair), jkaberry@hsph.edu, 617-432-2149 Resources OHRA Website: http://www.hsph.harvard.edu/ohra 22