🔬 Research
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.
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Prompt
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.
Instructions
Replace every [bracket] with your details before running. Works on ChatGPT, Claude, and Gemini.
Generated Output
This image was generated using the prompt above.
Examples
Example Input
ProtocolIdentity: Sleep Timing and Glucose Variability in Adults with Prediabetes; IRB-24-118; PI Dr. Lena Ortiz; Amendment 3 ChangeList: 1) Extend remote CGM wear from 10 to 14 days 2) Add optional evening saliva cortisol kit 3) Update exclusion: remove shift workers who already completed visit 1? No - clarify exclusion applies only at screening 4) New recruitment flyer for clinic lobby EnrollmentStatus: open; 28 enrolled of 60; visits ongoing RiskDraft: still minimal risk; added saliva is noninvasive; longer CGM may increase skin irritation reports ConsentAndRecruitment: main consent v4 needed; no assent (adults only); new flyer PacketPrefs: tracked changes protocol PDF, clean protocol, clean consent, summary table, flyer PDF Format: cover letter, summary table, risk narrative, reconsent tree, navigation, participant note, checklist, IRB questions
Example Output
1) COVER LETTER Dear IRB Members, Please accept Amendment 3 to IRB-24-118, Sleep Timing and Glucose Variability in Adults with Prediabetes (PI Dr. Lena Ortiz). We request approval to extend continuous glucose monitor wear from 10 to 14 days, add an optional evening saliva cortisol kit, clarify that the shift work exclusion applies at screening only, and add a clinic lobby recruitment flyer. Enrollment is open (28 of 60). A tracked change summary and clean documents are enclosed. Thank you for your review. Sincerely, [study coordinator name] 2) TRACKED CHANGE SUMMARY | ID | Section | Change gist | Rationale | Risk | Consent | Enrollment | | A1 | Procedures | CGM 10 to 14 days | capture full fortnight patterns | possible more skin irritation | yes update | current participants: reconsent before extending wear | | A2 | Procedures | optional saliva cortisol | exploratory stress marker | minimal, optional | yes optional checkbox | offer at next visit; decline ok | | A3 | Eligibility | shift work exclusion timing clarified | avoid mid study withdrawals | none | yes clarify language | applies screening only | | A4 | Recruitment | lobby flyer | speed accrual | none | n/a (flyer) | future participants | 3) RISK NARRATIVE Draft remains minimal risk [PI confirm]. Longer CGM increases duration of adhesive exposure; monitoring plan keeps irritation stop rules. Saliva kit is optional and noninvasive. No new invasive procedures. [confirm with HRPP if local requires continuing review wording changes]. 4) RECONSENT TREE - Not yet consented: use consent v4 at enrollment. - Enrolled, still in CGM window: reconsent before day 11 wear. - Enrolled, CGM already finished: inform of flyer and optional saliva only if they remain in follow up procedures that include it; otherwise notification letter without reconsent [PI confirm]. - Declines saliva: remain on core CGM protocol. 5) REVIEWER NAVIGATION - Tracked protocol PDF: Procedures and Eligibility highlights for A1-A3 - Clean protocol vX.Y - Clean consent v4 with optional cortisol checkbox - Flyer PDF one page 6) PARTICIPANT NOTE (draft) Short message: We are asking the IRB to allow two more CGM days and an optional saliva sample. Your care and study rights stay the same. A coordinator will review the updated consent before any change. 7) FILING CHECKLIST [ ] Cover letter [ ] Summary table [ ] Tracked protocol [ ] Clean protocol [ ] Clean consent v4 [ ] Flyer [ ] PI signature per PacketPrefs 8) LIKELY IRB QUESTIONS - Skin irritation rates to date? - How optional cortisol is documented in the chart? - Flyer claims limited to IRB approved wording? Mark answers [confirm with PI] rather than inventing rates.