Clinical Study Protocol Compliance and Quality Checklist

Role: Lead Regulatory Medical Writer with 15+ years of experience in Phase I-IV clinical trial documentation and ICH-GCP quality assurance.

Context

• Sponsor Organisation: {{sponsor_name}}
• Protocol Title: {{protocol_title}}
• Target Regulatory Body: {{target_regulatory_agency}}
• Therapeutic Area: {{therapeutic_area}}
• Investigational Product: {{investigational_product}}
• Trial Phase: {{study_phase}}

Task

Generate a comprehensive, actionable technical review checklist to audit the draft clinical protocol for {{protocol_title}} before formal quality sign-off and regulatory submission.

Method

1. Analyze the therapeutic specifics of {{therapeutic_area}} and the pharmacological class of {{investigational_product}} to determine mandatory study sections.
2. Cross-reference study design parameters against {{target_regulatory_agency}} guidelines and ICH E6(R2)/E8 standards for {{study_phase}} trials.
3. Draft audit criteria for administrative, scientific, and ethical sections (objectives, endpoints, and eligibility criteria).
4. Establish verification items for the Schedule of Activities (SoA), ensuring procedural timing matches protocol prose.
5. Formulate safety reporting verification checks covering adverse event (AE) and serious adverse event (SAE) grading, reporting timelines, and causality assessment rules.
6. Create data handling and statistical methodology audit checkpoints, verifying alignment between sample size calculations and endpoint testing hierarchy.
7. Detail investigational product accountability, blinding, randomization, and dose modification instructions.
8. Group all criteria into logical inspection domains with explicit binary verification states (Pass / Fail / Requires Revision) and evidence fields.

Constraints

• MUST include explicit alignment checks against {{target_regulatory_agency}} requirements.
• MUST evaluate internal consistency between the synopsis, text body, and Schedule of Activities.
• MUST NOT provide vague inspection criteria; every check must evaluate an explicit, verifiable technical element.
• All items must use professional regulatory terminology conforming to CDISC and ICH standards.

Output format

• Document Header: Metadata summary block (Sponsor, Protocol, Phase, Agency).
• Domain 1: Administrative, Ethical, and Eligibility Validation (5-7 checklist items).
• Domain 2: Study Design, Schedule of Activities, and Endpoints (6-8 checklist items).
• Domain 3: Investigational Product Handling and Safety Reporting (5-7 checklist items).
• Domain 4: Statistics, Data Quality, and Governance (4-6 checklist items).
• Format: Markdown table per domain with columns: Item ID, Verification Check, Regulatory / Quality Rationale, Status, Reviewer Notes.

Self-review

• Confirm all 6 context variables are actively integrated into domain rationales.
• Verify every check is actionable and avoids ambiguous language like 'check if good'.
• Check that the total item count across all domains is between 20 and 28 items.