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- A regulatory binder contains all study-specific information and regulatory documentation.
- It organizes essential documents, provides easy access to essential documents by the trial monitor, auditor, IRB, or regulatory authorities (e.g., Office for Human Research Protections (OHRP), Food and Drug Administration (FDA)) for review/audit purposes, and allows research team members to reference information.
A regulatory binder is also referred to as a study binder, investigator binder, administrative binder, regulatory file, or investigator's study files.
- For additional information about regulatory binders and management of research documentation, see Investigator Seminar Series session Documentation and Document Management in Clinical Research-Slides for Downloading and Video
What forms should my Regulatory Binder contain?
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- Investigator/research staff qualification documentation
- Current curricula vitae (CVs) are collected to demonstrate qualifications of all investigators, associate investigators, and study coordinators.
- Updated copies must be signed and dated.
- Expired CVs should be retained to validate qualification for the entire duration of the study.
- Licenses should be collected, as applicable. Do not remove expired licenses.
- Current curricula vitae (CVs) are collected to demonstrate qualifications of all investigators, associate investigators, and study coordinators.
- Training Records/Certificates/In-services
- If you are the Principal Investigator, you must ensure that there is adequate training for all staff participating in the conduct of the study.
- Retain evidence of training such as:
- Copies of investigators' human subjects research training certificates
- As applicable, additional training certifications for investigators and study staff
- List of attendees/sign-in sheets for relevant study related in-services conducted for investigators and study staff
- IRB documents
- Initial protocol and ALL amendments modifications with documented IRB and Sponsor approval
- All approved versions of the consent form
- All continuing review approvals from the IRB
- Study completion/termination report
- FDA Documents (if applicable)
- Form 1572
- FDA document history log: Track all correspondence submitted to/received from the FDA (e.g., annual IND reports)
- IND Safety Reports and Unanticipated Adverse Device Effect (UADE) Safety Reports
- Investigator's Brochure (IB) or Package Insert
- Include the package insert (in the case of an approved drug) or Investigator Brochure (IB) if one exists.
- If the package insert or IB is amended during the trial or is updated, it should be included in the Regulatory Binder and provided to the IRB in real time.
- Adverse Event (AE) Tracking Log
- This is a log of the adverse events that occur on the protocol.
- Recruitment advertisement/letters
- These materials should have documented IRB approval.
- Sponsor Correspondence
- Telephone logs, meeting minutes and/or relevant email and written correspondence to/from the sponsor
- SAE reports, as applicable
- Site visit reports
- Laboratory Certification and Laboratory Normal/Reference Ranges
- All copies of clinical laboratory improvement amendments (CLIA) certifications for all lab tests, the results of which will be used for purpose of the study
- Copy of normal ranges for all labs/tests included in protocol
- If using results for a specific participant as the reference ranges, blacken out all participant specific identifiers, copy and then place in the binder.
- Specimen Tracking Log, as applicable
- A log of research specimens that includes type of specimen, purpose of storage, location of storage and link to participant ID number. If applicable, the log should be modified to track if consent for future use was obtained, declined, or withdrawn.
- Screening/Enrollment Log
A screening log is a log without identifying information used to track subjects who were screened for the study including screen failures and those enrolled in the study. A screening/enrollment log should include:- All participants screened
- Participants screened who declined further participation (include reason for declining)
- Participants screened who were deemed ineligible for study participation
- Participants screened who did not continue on to enrollment and study intervention or treatment (include reason i.e., death before enrollment etc.)
AND - Track screen failures: Participants who consent to participate in the study, who do not meet one or more criteria required for participation in the trial during the screening procedures, are considered screen failures
- Indicate in the protocol how screen failures will be handled in the trial, including conditions and criteria upon which re-screening is acceptable, when applicable
- Rescreened participants should be assigned the same participant number as for the initial screening.
- A sample screening/enrollment log can be accessed here.
- Site Visit Log
- Log in which monitors will document their visits
- Site staff initials/verifies that a monitor was present on specific dates
- Visit correspondence, such as confirmation or follow up letter
- For consecutive days, each day is entered separately. A sample Site Visit log can be accessed here.
- Delegation of Responsibility Log
- As the investigator, this is where you document what tasks are delegated to members of your research team based on each individual's competencies.
- This log should be kept up to date as new study personnel are added and/or study roles change.
- This linkcontains a sample delegation of tasks/authority log.
- Protocol Deviation (PD) Log
- This is a log to track all deviations that occur over the life the protocol. A sample PD log can be accessed here.
- Pharmaceutical Information, as applicable (In some cases, this information and documents will be kept by the Pharmacy.)
- Drug accountability including shipping and dispensing records
- Sample of labels attached to investigational product containers
- Decoding/breaking the blind procedures (if not detailed in protocol)
- Data Safety and Monitoring Documents
- Study reports, recommendations and minutes generated from meetings of the data and safety monitoring entity
- Additional contents of your Regulatory Binder may include the following:
- Blank set of Case Report Forms
- Record of retained tissue or fluid specimens
- Notes to File
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