Prompt
Draft IRB Submission Cover Letter
Use this when you are submitting a new protocol, amendment, or continuing review to the ethics board.
How to use it
- Copy the prompt and paste it into ChatGPT, Claude, Gemini or any other AI.
- Replace every {{placeholder}} with your own details, or let the AI ask you for them.
- Use the follow-ups below to go deeper.
Role You are a clinical research coordinator drafting a cover letter for an ethics board submission. Optimise for a clear, accurate, complete letter that matches the submission type and lets the reviewer locate every required item quickly.
Context you provide
- {{submission_type}}: new protocol, amendment, or continuing review
- {{protocol_title}}: full study title
- {{protocol_number}}: sponsor or site protocol ID
- {{principal_investigator}}: name and credentials
- {{institution_name}}: site or institution
- {{irb_name}}: ethics board or office name
- {{review_type_requested}}: full board, expedited, or exempt
- {{submission_date}}: date of this letter
- {{summary}}: purpose of study or summary of changes
- {{risk_benefit_summary}}: brief risk and benefit statement
- {{funding_sponsor}}: funder or sponsor, if any
- {{prior_approval_date}}: previous approval date, if any
- {{recruitment_status}}: not started, ongoing, or closed
- {{attachments}}: list of documents included
- {{contact_details}}: name, role, email, phone
Instructions
- Ask for any missing inputs, then draft the letter using only what is provided.
- Open with the submission type, protocol title, protocol number, and principal investigator.
- State the review type requested and the submission date.
- Summarise the study or the changes in plain, factual language, then add the risk and benefit statement.
- Note prior approval date and recruitment status where relevant.
- List attachments in the order the IRB expects, if that order is known.
- Close with contact details and an offer to provide further information.
Output format A one-page cover letter: subject line, salutation, three to five short paragraphs, sign-off, and attachment list. Formal, neutral, factual tone. No marketing language, no speculation, no unrelated study details.
Guardrails
- Do not invent protocol numbers, approval dates, regulation citations, or IRB names; use only supplied inputs and flag blanks.
- Tell the user to check the IRB's current submission requirements and local regulations before sending.
- Do not interpret regulations; refer interpretation questions to the IRB office or compliance officer.
Example Submission type: continuing review; protocol: ABC-123; PI: Dr. R. Patel; review type: expedited; attachments: consent form, progress report.