1. Purpose

To define the content, organisation, maintenance and quality control of the regulatory binder (trial master file at site level) so that essential documents are complete, current and available for monitoring, audit and inspection.

2. Scope

Applies to every interventional and observational study conducted at Quillbrook, in paper binders, validated electronic systems, or a documented hybrid of both.

3. Responsibilities

• Regulatory Affairs Manager: Owns the binder structure, performs quality control reviews, and maintains the essential document index.
• Regulatory Specialist / Coordinator: Files documents within five business days of receipt and maintains version control of protocols and consent forms.
• Principal Investigator: Signs the Form FDA 1572, financial disclosure forms and the delegation of authority log, and keeps them current.
• Quality Assurance: Audits binders at least annually and before any scheduled sponsor audit or inspection.

4. Definitions

Essential documents

Documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.

Form FDA 1572

The Statement of Investigator, in which the investigator commits to conduct the study according to the protocol and applicable regulations.

Delegation of authority log

The investigator-signed list of study tasks delegated to named site staff, with effective dates.

Financial disclosure

The investigator's disclosure of financial interests and arrangements required by 21 CFR Part 54.

5. Procedure

1. Create the regulatory binder at study start-up using the site's standard section index, and record whether each section is paper, electronic or hybrid.
2. File the protocol and all amendments in version order, with the date each version became effective at the site and the corresponding IRB approval.
3. File every IRB submission, approval letter, continuing review approval, and safety report acknowledgment as described in REG-002.
4. Maintain the current and all previous IRB-approved informed consent documents, including translations and short forms, each stamped or otherwise identified with its approved version.
5. Obtain a Form FDA 1572 signed and dated by the Principal Investigator before study initiation, and issue a revised 1572 when a sub-investigator, facility or laboratory changes.
6. Collect financial disclosure forms from the investigator and every sub-investigator before enrolment, and update them during the study and for one year after completion.
7. Maintain the delegation of authority log so that each delegated task has a named, trained individual with start and, where relevant, end dates signed by the investigator.
8. File current CVs, licences, GCP certificates and protocol training documentation for every person on the delegation log, cross-referenced to TRN-001.
9. Maintain laboratory documentation: certification or accreditation, current normal ranges, and the laboratory manual for each version used.
10. File the signed clinical trial agreement, budget, confidentiality agreement and any amendments, with financial terms redacted where the sponsor requires.
11. Maintain investigational product records including shipment receipts, temperature records, accountability logs and return or destruction records per CON-003.
12. Maintain correspondence with the sponsor, IRB and regulatory authorities, including monitoring visit follow-up letters and query resolutions per CON-005.
13. Perform a documented quality control review of each active binder at least quarterly, using a checklist that verifies completeness, currency, and absence of missing signatures or dates.
14. Correct errors in paper records with a single line through the error, the correct entry, and the initials and date of the person making the change; never obliterate or use correction fluid.
15. At study close-out, reconcile the binder against the essential document index, document any missing item with a note to file, and archive per DAT-003.

6. References

• 21 CFR Part 312.62 — Investigator recordkeeping and record retention
• 21 CFR Part 54 — Financial Disclosure by Clinical Investigators
• 21 CFR Part 56 — Institutional Review Boards
• ICH E6(R3) Good Clinical Practice, essential documents
• TRN-001 Training & Qualification of Research Personnel

7. Revision History

• v2.0 · Sep 13, 2021 — Added hybrid paper/electronic filing rules.
• v3.0 · Mar 18, 2024 — Added quarterly quality control review with checklist.
• v3.2 · Oct 06, 2025 — Clarified financial disclosure update obligations.