Protocol Quality Checklist: 10 Things to Double-Check Before Submission
A well-written protocol is the backbone of a successful clinical trial. Before you hit "submit," make sure your protocol checks all the right boxes. Here are 10 critical items to double-check—simple, actionable, and designed to help you avoid common pitfalls.
Want a printable version of this checklist for your team? Download the Protocol Quality Checklist (PDF).
1. Clear Study Objectives
Why it matters: Fuzzy objectives lead to unclear endpoints and flawed design.
Checklist Tip: Confirm your primary and secondary objectives are specific, measurable, and logically tied to your endpoints.
How to do it: Use the PICO method (Population, Intervention, Comparator, Outcome) to frame each objective, and review with your statistician to ensure clarity.
2. Consistent Terminology
Why it matters: Inconsistent language causes confusion and complicates regulatory review.
Checklist Tip: Standardize key terms across all sections (e.g., population descriptions, assessments, procedures).
How to do it: Use the search function in your document to locate repeated terms and check for consistency (e.g., "subject" vs. "participant"). Create a glossary if needed.
3. Eligibility Criteria Alignment
Why it matters: Misaligned criteria can result in protocol deviations and patient enrollment issues.
Checklist Tip: Cross-check inclusion/exclusion criteria against study objectives and planned analyses.
How to do it: Create a table that links each criterion to the scientific rationale and endpoint it supports. Review for internal logic and clarity.
4. Defined Endpoints and Assessments
Why it matters: Vague or mismatched endpoints make your trial hard to interpret and defend.
Checklist Tip: Ensure endpoints are clearly defined and all assessment tools, timepoints, and methods are outlined.
How to do it: List all endpoints in a dedicated section and match each to a corresponding schedule of assessments. Have a biostatistician verify feasibility.
5. Realistic Visit Schedule
Why it matters: Overly complex or unrealistic schedules increase dropout risk and site burden.
Checklist Tip: Review your schedule of events for feasibility, and verify alignment with assessments and safety monitoring.
How to do it: Ask a site coordinator to review the visit schedule for operational feasibility. Use a calendar mock-up to simulate patient burden.
6. Complete Safety Monitoring Plan
Why it matters: Missing safety details can delay approval and jeopardize participant protection.
Checklist Tip: Confirm your plan includes AE/SAE definitions, reporting timelines, and oversight procedures.
How to do it: Include a safety flowchart and checklist outlining each safety-related responsibility. Double-check that all safety terms align with current regulatory guidance.
7. Regulatory and GCP Compliance
Why it matters: Noncompliance risks trial suspension and reputational damage.
Checklist Tip: Double-check your protocol complies with ICH-GCP, local regulations, and sponsor-specific requirements.
How to do it: Use a GCP compliance checklist or template to ensure key requirements are included. Consider an internal audit or review by a regulatory specialist.
8. Sample Size Justification
Why it matters: Weak or missing rationale undermines your trial’s scientific credibility.
Checklist Tip: Include clear justification based on statistical assumptions, effect size, and power.
How to do it: Have your biostatistician prepare a separate statistical section or appendix. Include references and clearly state all assumptions.
9. Clear Roles and Responsibilities
Why it matters: Ambiguity leads to miscommunication and protocol deviations.
Checklist Tip: Define responsibilities of investigators, monitors, sponsors, and other key parties.
How to do it: Include a responsibilities table or RACI matrix (Responsible, Accountable, Consulted, Informed) for clarity.
10. Version Control and Consistency
Why it matters: Inconsistencies across sections or attachments can cause confusion and delay approvals.
Checklist Tip: Do a final sweep for alignment between the protocol, synopsis, appendices, and referenced documents.
How to do it: Use a document comparison tool (e.g., Adobe Compare Files or MS Word Compare) and review section headers, numbering, and references for alignment.
Disclaimer: This blog post is for informational purposes only and does not constitute regulatory, legal, or medical advice. Clinical trial procedures should be tailored to your specific study and reviewed by qualified professionals.