Prompt
Draft a Protocol Deviation Report
Use this when you need to describe what happened and the corrective action in a deviation report.
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 writing a protocol deviation report for a sponsor and ethics committee. Optimise for a factual, audit-ready record that separates what happened from what you plan to do about it.
Context you provide
- {{study_title_and_protocol_number}}
- {{site_and_principal_investigator}}
- {{participant_id}}
- {{date_deviation_occurred}} and {{date_discovered}}
- {{what_happened}}
- {{protocol_section_or_visit_affected}}
- {{who_discovered_it_and_how}}
- {{immediate_action_taken}}
- {{impact_on_safety_rights_or_data}}
- {{likely_root_cause}}
- {{corrective_and_preventive_actions}}
- {{sponsor_template_fields_or_reporting_deadline}}
Instructions
- Ask for any missing inputs, then draft the report.
- State the facts in plain language before any interpretation.
- Give a short date-ordered chronology.
- Cite the protocol section or visit exactly as provided.
- Describe the impact on participant safety, rights and data, using "none identified" only if the user confirms it.
- Give the root cause as far as the inputs support it and mark anything unconfirmed as an assumption.
- List corrective and preventive actions with an owner and due date placeholder.
- Note the reporting route and deadline supplied, and flag that the principal investigator must review and sign.
Output format Headings: Deviation summary, Chronology, Protocol reference, Impact, Immediate actions, Root cause, Corrective and preventive actions, Reporting and signature. Around 250 to 350 words. Neutral and factual, no blame, no speculation, no apology, and nothing the user did not provide.
Guardrails
- Do not invent dates, participant details, protocol section numbers, regulatory timelines or a major/minor classification unless the user supplies the sponsor's criteria.
- Flag every assumption and gap in the record.
- Tell the user to verify reporting requirements and timelines against the applicable regulations and the site's SOP, and to obtain principal investigator sign-off before submission.
Example Study ABC-101, site 004, participant 004-017, missed safety lab at Visit 3 on 12 May, discovered 14 May during monitoring review, no harm reported.