1. Purpose

To define how Quillbrook Clinical Research Center authors, reviews, approves, distributes, revises, retires and archives controlled standard operating procedures (SOPs) so that site practice is documented, current, traceable and inspection-ready.

2. Scope

Applies to all controlled documents in the Quillbrook quality system: SOPs, work instructions, forms, templates and logs, in both paper and electronic form, across every department and study.

3. Responsibilities

• Quality Assurance Director: Owns the document control system, assigns SOP numbers, maintains the master SOP index, and grants final quality approval.
• SOP Author / Process Owner: Drafts and revises content, ensures technical accuracy, and identifies affected departments and training impact.
• Department Managers: Review drafts for operational feasibility and confirm their staff complete assigned training before the effective date.
• Training & Compliance Coordinator: Generates read-and-understand assignments for each new version and monitors completion.
• All Personnel: Work only from the current effective version and acknowledge assigned SOPs by the stated due date.

4. Definitions

Controlled document

A document whose version, distribution and retirement are managed by the quality system.

Effective date

The date on which a version becomes the required practice; prior versions become historical on that date.

Periodic review

The scheduled assessment of an SOP, performed at least annually, to confirm it remains accurate and compliant.

Retired

A version withdrawn from use and archived; it is retained for the record-retention period but must never be used for current work.

5. Procedure

1. Identify the need for a new or revised SOP from a regulatory change, a sponsor or inspection finding, a CAPA, a process change, or the outcome of a periodic review.
2. Request an SOP number from Quality Assurance using the category prefixes defined in the master SOP index (for example QA, TRN, REG, SUB, CON, DAT, HIP).
3. Draft the document using the approved SOP template, completing every required section: Purpose, Scope, Responsibilities, Definitions, Procedure, References and Revision History.
4. Circulate the draft for technical review to the process owner and every department named in Applicable Departments; document reviewer comments and their resolution.
5. Submit the reviewed draft to Quality Assurance for compliance review against 21 CFR Parts 11, 50, 56 and 312, ICH E6(R3), 45 CFR Parts 160 and 164, and the Common Rule at 45 CFR Part 46, as applicable.
6. Obtain approval signatures from the process owner, the Quality Assurance Director and, where medical judgment is involved, the Chief Medical Officer or Lead Principal Investigator.
7. Assign the version number: increment the major number (for example 3.0 to 4.0) for changes that alter required practice, and the minor number (3.0 to 3.1) for editorial or administrative corrections.
8. Set an effective date that allows a minimum of fifteen calendar days for staff training, and no more than thirty days, before the version becomes required practice.
9. Publish the approved version to the electronic SOP library, mark the previous version Retired on the effective date, and remove all uncontrolled paper copies from circulation.
10. Generate read-and-understand assignments for every applicable employee with a default due date of thirty calendar days from assignment, and capture electronic signatures in accordance with DAT-002.
11. Monitor training completion weekly; escalate assignments that pass their due date to the employee's supervisor, then to the department director after an additional seven days.
12. Perform a documented periodic review of each effective SOP at least annually; record the outcome as 'no change required', 'minor revision' or 'major revision' and update the next review date.
13. Retire an SOP that is no longer needed by documenting the justification, obtaining Quality Assurance approval, and moving the final version to the controlled archive.
14. Archive retired versions, approval records, review records and training records for the retention period defined in DAT-003, and make them retrievable for sponsor audits and FDA inspections.

6. References

• 21 CFR Part 11 — Electronic Records; Electronic Signatures
• 21 CFR Part 312 — Investigational New Drug Application
• ICH E6(R3) Good Clinical Practice
• QA-003 Internal Audits & Inspection Readiness
• DAT-002 Electronic Records & Electronic Signatures
• DAT-003 Study Close-Out & Record Retention

7. Revision History

• v1.0 · Feb 01, 2019 — Initial issue of site document control procedure.
• v2.0 · Jun 15, 2021 — Added periodic review cycle and retirement workflow.
• v3.0 · Sep 01, 2023 — Aligned version numbering and training timelines with sponsor audit findings.
• v4.0 · Jan 15, 2026 — Moved acknowledgment to electronic signature per 21 CFR Part 11; added escalation path.