1. Purpose

To describe how Quillbrook prepares, submits and tracks Institutional Review Board submissions, including initial review, amendments, continuing review, reportable events and study closure.

2. Scope

Applies to all human subjects research conducted at or by Quillbrook, whether reviewed by a central IRB or a local institutional IRB.

3. Responsibilities

• Regulatory Affairs Manager: Prepares and tracks submissions, maintains the IRB correspondence file, and monitors approval expiry dates.
• Principal Investigator: Reviews and signs submissions and is responsible for ensuring no activity occurs outside IRB approval.
• Clinical Research Coordinators: Supply enrolment data, deviation summaries and consent version information for continuing review.
• HIPAA Privacy Officer: Reviews authorisation language and waiver requests for compliance with 45 CFR 164.508 and 164.512(i).

4. Definitions

Continuing review

Periodic IRB review of an approved study, at intervals appropriate to the degree of risk and not less than once per year where required.

Amendment

Any change to the protocol, consent document, recruitment material or investigator team requiring IRB review.

Reportable new information

Information that may affect the risk-benefit assessment, such as unanticipated problems involving risk to subjects.

Expedited review

IRB review by the chair or an experienced reviewer for eligible minor changes and minimal-risk research.

5. Procedure

1. Confirm which IRB of record applies and obtain its current submission forms, deadlines and meeting calendar before preparing any submission.
2. Assemble the initial submission: protocol, investigator's brochure or device manual, consent and assent documents, recruitment materials, HIPAA authorisation, questionnaires, and investigator qualifications.
3. Have the Principal Investigator review and sign the submission, and obtain Quality Assurance review of the consent document against SUB-001 before submission.
4. Submit through the IRB's designated portal, record the submission date and tracking number, and file the confirmation in the regulatory binder.
5. Do not screen, consent or enrol any subject, and do not use any recruitment material, until written IRB approval for that specific version is received.
6. Prepare amendments promptly and implement no change before approval, except where necessary to eliminate an apparent immediate hazard to subjects.
7. Report a change made to eliminate an immediate hazard to the IRB and the sponsor within five business days, documenting the hazard and the action taken.
8. Submit reportable new information, including unanticipated problems involving risks to subjects and serious non-compliance, within the timeframe specified by the IRB's policy.
9. Track approval expiry dates and submit continuing review at least sixty calendar days before expiry, including enrolment numbers, withdrawals, deviations, adverse events and the current consent version.
10. If approval lapses, immediately stop all research activity other than interventions necessary for subject safety, notify the sponsor and Quality Assurance, and submit a deviation report under CON-002.
11. Implement newly approved consent versions immediately for new subjects, and re-consent enrolled subjects when the IRB requires it, per SUB-001.
12. Submit a study closure report to the IRB when enrolment is complete, all subjects have finished follow-up and data collection has ended.
13. File every submission, approval letter, acknowledgment and item of correspondence in the regulatory binder within five business days of receipt.

6. References

• 21 CFR Part 56 — Institutional Review Boards
• 21 CFR Part 50 — Protection of Human Subjects
• 45 CFR Part 46 — Common Rule
• 45 CFR 164.512(i) — Uses and disclosures for research purposes
• SUB-001 Informed Consent Process & Documentation

7. Revision History

• v1.0 · Aug 05, 2020 — Initial issue.
• v2.0 · Jun 23, 2025 — Added lapse-of-approval handling and 60-day continuing review lead time.