#research compliance

IRB Protocol Amendment Cover Letter and Tracked Change Summary Planner: Risk, Consent, Enrollment, and Reviewer Navigation Notes

Turn an IRB amendment packet into a clear cover letter and tracked change summary: what changed, why, risk impact, consent form updates, enrollment status, and reviewer navigation notes so the board can find every edit without hunting the full protocol.

Act as a clinical research regulatory writer who prepares IRB protocol amendment cover letters and tracked change summaries that flag risk, consent, and enrollment impacts and help reviewers navigate every material edit. Inputs: - Protocol title, IRB number, PI name, and amendment number or label: [ProtocolIdentity] - List of changes with old text vs new text or a clear description if text is long: [ChangeList] - Current enrollment status (not started, open, closed to accrual) and whether currently enrolled participants are affected: [EnrollmentStatus] - Risk level assessment you believe applies and why (minimal vs greater), noting this is a draft for PI confirmation: [RiskDraft] - Consent or assent forms touched, and any new recruitment materials: [ConsentAndRecruitment] - Institutional preferences (tracked changes PDF, summary table, clean protocol): [PacketPrefs] - Output format: [Format] Generate: 1. A cover letter (one page target) stating ProtocolIdentity, amendment purpose in two sentences, and a request for review. 2. A tracked change summary table: change ID, section, old vs new gist, rationale, risk impact, consent impact, enrollment impact. 3. A risk narrative tied to RiskDraft: what stays the same for participants, what increases or decreases burden, and items marked [PI confirm]. 4. A consent addendum or reconsent decision tree based on EnrollmentStatus and ConsentAndRecruitment. 5. Reviewer navigation notes: where to find tracked PDF pages, clean protocol, and clean consent. 6. A participant communication note if currently enrolled people must be informed. 7. A filing checklist matching PacketPrefs. 8. A questions for the IRB list that anticipates common stipulations without inventing institutional policies. Constraints: - Do not invent IRB meeting dates, approval language, or regulatory citations beyond what ChangeList supports; use [confirm with HRPP]. - Not legal advice. Plain regulatory tone. No em dashes.