Industry sponsors may provide investigators with a regulatory binder to be used to maintain the essential documents for the trial. Investigators who are conducting investigator-initiated trials are encouraged to use the Penn State's REDCap eRegulatory Binder for electronic storage and organization of regulatory documentation.
The eRegulatory Binder can be used alone or alongside the use of paper records. Additional information regarding access and utilization of the REDCap eRegulatory Binder can be found at the Office for Research Protection Quality Assurance website.
The following list represents the required essential documents that must be filed in the regulatory binder. All essential documents must be available for audit/inspection by the sponsor and regulatory authorities. The eREgulatory Binder provides all essential tabs and information about what needs to go under each tab.
See also the Regulatory Binder – Documentation Checklist.
| Tab | Documents | References to Regulations |
|---|---|---|
| Protocol | •Current protocol and all previously approved versions •When applicable, a copy of the fully executed protocol signature page for original protocol and all approved versions |
ICH GCP E6 Section 8.2.2 and 8.3.2 |
| CVs & Licensure | •Signed and dated CVs for all study staff •Valid medical licenses/professional certifications for all study staff |
ICH GCP E6 Sections 4.1.1, 8.2.10, 8.3.5 |
| Logs | •Pre-Screening Log: Captures subjects who have been pre-screened to determine initial eligibility for enrollment. •Enrollment Log: Captures all subjects who sign a consent form. •Delegation of Authority/Delegation of Responsibility Log: Documents the study-related procedures delegated to staff. The PI should initial, sign and date this list, and update it as new staff or study procedures are added to the protocol; see below this table for details •Training Log: Documents training of all study staff on protocol-related procedures; see below this table for details •Adverse Event Tracking Log: Tracks and ensures timely reporting of all applicable adverse events to the IRB; often done electronically •Minor Deviation/Violation Tracking Log: Provides a record of all minor deviations from the approved protocol and facilitates reporting at continuing review; often done electronically •Tissues and/or Blood Sample Log: Tracks tissue and/or blood samples collected during research |
ICH GCP E6 Sections 8.3.20, 8.3.25 |
| IRB | •Signed and dated submissions •Application •Continuing review(s) •Amendments •Adverse events •Violations/deviations •Closeout information •Approval letters and/or notification of IRB decisions •Investigator response(s) to IRB notification (if applicable) •Approved recruitment materials •Approved educational materials/additional study information distributed to subjects (e.g., subject diary) •Memo regarding FWA, IRB registration •Copy of IRB membership roster •Any additional correspondence relating to the study, such as emails |
ICH GCP E6 Sections 8.2.7, 8.2.8; Code of Federal Regulations 45 CRF 46, 21 CRF 50, 21 CRF 56 |
| Consent/ Assent Forms | •Current IRB-approved consent and/or assent form version(s) with the IRB approval stamp | Code of Federal Regulations 45 CFR 46, 21 CFR 50, 21 CFR 56; ICH GCP E6 Sections 8.2.3, 8.2.7, 8.3.2, 8.3.12 |
| Financial Disclosure | •Signed and dated FDA Financial Disclosures for all clinical investigators listed on the form FDA 1572 (drug) or IRB application (device) | Code of Federal Regulations 21 CRF 54 |
| Laboratory Documents | •Current lab certification (e.g., CLIA, CAP) •Normal lab/reference values |
ICH GCP E6 Sections 8.2.11, 8.3.6 |
| Drug/Device Accountability | •Drug/device shipment and receipt records •Drug/device accountability log •Most recent version of investigator's brochure or device manual |
ICH GCP E6 Sections 8.2.14, 8.2.15 |
| Data Collection | •Blank set of CRFs, data collection sheets, and IRB-approved study questionnaires •If data are being captured electronically a copy of the eCRF completion guidelines could be filed here |
21CRF 312; ICH GCP E6 Sections 8.3.14, 8.3.15, 4.9.3 |
| DSMB (if applicable) | •Copy of all Data and Safety Monitoring Board (DSMB) reports •Additional correspondences with DSMB (e.g., meeting minutes, information provided to the DSMB, emails) |
Guidance for Clinical Trial Sponsors-Establishment and Operation of Clinical Trial Data Monitoring Committees, Section 4.4.3.2 |
| Correspondence | •All relevant communications, other than site visits, to document any agreement or significant discussions regarding trial or administration, protocol violations, trial conduct, adverse event reporting, etc. •Includes communications to and from the Sponsor and/or the study team •Communications about a specific subject should be filed with source documents for that subject |
ICH GCP E6 Sections 8.3.11 |
| Monitoring | •Monitoring Log: Documents any form of study oversight/monitoring. Both the monitor and clinical research coordinator should sign the log. •Pre-study Visit Report, Site Initiation Visit Reports, Monitoring Visit Reports, Close-Out visit reports or follow up letters if visit reports are not provided. |
ICH GCP E6 Sections 8.2.19, 8.2.20, 8.3.10, 8.4.5 |
| Subject Identification Code List | •This is a document containing a unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data. | ICH GCP E6 Sections 1.58, 8.3.21, 8.4.3 |
| Final Study Report | •Final report by the Investigator to the IRB, and where applicable, to the regulatory authorities to document completion of the trial. | ICH GCP E6 Section 8.4.8 |
Research Topic