1. 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 1

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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:
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.

8. 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).

9. 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.

10. 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

11. 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

12. 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

13. 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

14. DSMB Documentation Reports from DSMB meetings
Additional correspondences with DSMB: s
Letters
Meeting minutes

15. 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

16. 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.

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

18. 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

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

20. 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

21. 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

22. Questions? Quality Improvement Program Staff IRB Operations Staff
Stanley Estime,
Lisa Gabel,
Leslie Howes,
Alyssa Speier,
IRB Operations Staff
Department Assigned IRB Review Specialist:
Julie Kaberry (IRB Administrative Chair),
Resources
OHRA Website: 22