1. Regulatory Binder: Maintaining Essential Study Documentation
11/12/2018
Regulatory Binder: Maintaining Essential Study Documentation

2. Regulatory Binder
Based on ICH-GCP defined Essential Documents and OHRA’s Recordkeeping/Retention requirements
ICH-GCP: International Conference on Harmonization – Good Clinical Practice
Best Practice Standard
Provides a template for maintaining and organizing documentation to ensure compliance with federal regulations, institutional policies, and good clinical practice
Alternatives are acceptable. You can create your own way of organizing the required documentation in a way that works best for you and your study team. BE CONSISTENT!

3. Electronic Regulatory Binder (eBinder)
The eBinders, developed in REDCap and Box.com, facilitate proper study management through electronic storage of study/regulatory documents and study management tools/logs.
Instructions for institution-specific regulatory requirements, best practice recommendations, and GCP/Federal regulations are contained within each regulatory binder

4. Electronic Regulatory Binder (eBinder)
The eBinders allows you to:
Quickly download a custom template or utilize QIP’s template to customize your own binder to fit your study needs.
Maintain regulatory documents for one or multiple studies.
Securely share its contents with local and international study team members.
How to access the binders:
Contains instructions for accessing our eBinder templates in REDCap and Box.com.
Contact Stanley Estime to obtain access to the Box Template or if you have difficulty accessing REDCap’s eBinder.

5. Regulatory Binder Sections
All Studies
Study Specific
Licensure
Investigator Brochure/ Device Manual/ Package Insert
Laboratory Documentation
Drug/Device
NIH
Sponsor
DSMB
External/Local Ethical Review
Protocol
CVs for all study staff
Logs
IRB Documentation
Consent and Recruitment Materials
Data Collection Materials
Training
Data Protection

6. Essential Documents (all studies)
Section
Purpose
Considerations / Recommendations
Protocol
Demonstrates investigator and/or sponsor agreement to the study aims, research design, research site(s), and all procedures, particularly those that involve human subjects.
Ensure that the version number/date reflects the current, approved Research Protocol approved by the IRB.
CVs and licensures
Documents the qualifications and expertise of study staff to perform delegated tasks.
CVs and licenses should be updated every 2 years to confirm that the information is current and accurate.
CVs should be signed and dated
Maintain licensure 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., Enrollment Log, Delegation of Responsibility Log).
Information in QIP log templates can be customized to fit a specific study.
IRB Documentation
Demonstrates that the IRB has reviewed and approved the initial project and all modifications prior to the initiation of study procedures. Confirms that continuing review has been performed (as applicable) and that reportable new information has been communicated to the IRB.
To simplify recordkeeping and avoid creating duplicate files, IRB documentation should be maintained in ESTR. Include a signed and dated note-to-file in the Regulatory Binder detailing the location of the documentation.

8. Essential Documents (all studies)
Section
Purpose
Considerations / Recommendations
Informed Consent
Recruitment Material
Documents that information given to participants supports their ability to give voluntary informed consent.
Ensure that the most recently approved consent form and recruitment documents are used in the field.
The most recently approved consent form and recruitment documents can always be accessed in ESTR.
Data Collection
Maintains original copies of all forms used to collect study data (e.g., case report forms, questionnaires, surveys).
Only blank copies of forms should be kept in the Regulatory Binder.
The most recently approved data collection forms can always be accessed in ESTR.

9. Essential Documents (all studies)
Section
Purpose
Considerations / Recommendations
Training
Documents adequate human subjects training as well as any other study-specific training for all IRB approved study personnel.
All study staff approved by the HLMA IRB must complete CITI human subjects training requirements every 3 years.
Additional institution, department, or study-specific training requirements and time frames may vary (e.g., data security, laboratory safety).
Data Protection
Maintains documentation of data protection procedures not included in the Research Protocol, as well as specific records that may not be included in ESTR.
For all documents maintained in ESTR, include a signed and dated note-to-file in the Regulatory Binder detailing the location of the documentation.

10. Participant Files
Maintain participant files securely and separate from the Regulatory Binder
Include original signed consent documents
Depending on confidentiality provisions outlined in the Research Protocol, signed consent forms may be kept separate from the participant’s research data
File completed data collection forms and source data
Communication with participants
As above, depending on confidentiality provisions outlined in the Research Protocol, communication that includes identifiers may be kept with signed consent documents and separate from research data

11. Single IRB and Multi-site Research
11/12/2018
Single IRB and Multi-site Research
Include all institutional determinations and reliance agreements (SmartIRB or IRB Authorization Agreement and Institutional acknowledgments) in an External/Local Ethical Review file
Regulatory documentation should reflect any reliance agreements
The Overseeing IRB’s researchers should document up to date training and activities for all study staff that fall under the reviewing IRB’s oversight.
Most reliance agreements allow for the reviewing institution to conduct an audit, for cause, of the ceding institution’s study documentation
Regulatory documentation should still be kept at each institution to at least maintain site specific information.
The protocol will determine how Participant Files should be maintained at each site.

12. Tips for Successful Record Keeping
11/12/2018
Tips for Successful Record Keeping
Customize the Regulatory Binder to meet the specific criteria for your study
Maintain binders in a secure location (e.g., locked file cabinet, password protected computer)
Document and update materials in the Regulatory Binder in real time
File hard copy documents in reverse chronological order (most recent on top)

13. Tips for Successful Record Keeping
11/12/2018
Tips for Successful Record Keeping
Avoid maintaining duplicate records, particularly IRB documents (e.g., in ESTR, electronically on a shared drive, and hard copy in a paper-based Regulatory Binder)
Review documentation routinely
QIP recommends using the Investigator Self-Assessment as a guide when reviewing regulatory documentation
Address and resolve documentation issues immediately upon discovery

14. Note-to-File A Note-to-File can reconcile many issues
11/12/2018
Note-to-File
A Note-to-File can reconcile many issues
When in doubt, write a note!
Use to explain apparent discrepancies
Use to identify location of files that are maintained outside of the Regulatory Binder (e.g., in electronic format on a shared drive or in ESTR)
Each note-to-file should include the study number, PI name, date, and the initials of the person writing the note-to-file

15. Record Retention
OHRA Policy: Maintain documentation for at least 7 years from study closure date
The Regulatory Binder and study documents, including participant files, must be maintained securely and readily available to auditors
Check with your sponsor to ensure compliance with their record retention policy

16. Resources OHRA web site Quality Improvement Program (QIP) web site
11/12/2018
Resources
OHRA web site
Quality Improvement Program (QIP) web site
QIP Study Management Tools - including Regulatory Binder tabs, Investigator Self-Assessment, and Note-to-File template

17. OHRA Quality Improvement Program (QIP)
Alyssa Speier, MS, CIP
Associate Director, Office of Regulatory Affairs and Research Compliance
Lisa Gabel, CIP
Senior QA/QI Specialist
Scott Meyers, CIP
QA/QI Specialist