Clinical Trial Protocol (ICH E6(R3) GCP)

Healthcare Clinical Trials Compliance ICH GCP

Overview

Draft and validate clinical trial protocols per ICH E6(R3) Good Clinical Practice and ICH E8(R1) General Considerations for Clinical Studies. Ensures the protocol contains all required elements for ethics committee / IRB submission and regulatory filing (EMA, FDA IND, ANVISA).

Example Conversation

You: We’re preparing a Phase II protocol for our oncology compound. Can you draft the protocol with all ICH E6(R3) §6 sections and then validate it?

Agent: I’ll draft the protocol with study design, eligibility, interventions, schedule of assessments, safety monitoring (AE/SAE definitions and reporting timeline), statistical analysis, and ethics (informed consent, DSMB). Then I’ll run protocol_completeness_checker on the draft.

Agent: Created protocol-draft.md. Running protocol_completeness_checker…

Agent: Check FAIL — SAE reporting timeline is not explicitly stated. Adding “SAE reporting within 24 hours to sponsor and within 7 days to regulatory authority” to the safety section.

Agent: Re-ran protocol_completeness_checker: PASS. All mandatory sections, primary endpoint success criterion, SAE timeline, informed consent, and DSMB are present.

What the Tools Validate

The skill includes one extension tool:

protocol_completeness_checker checks the protocol against ICH E6(R3) §6 required content:

Mandatory sections — Objectives, design, eligibility, interventions, safety, statistics, ethics must all be present.
Primary endpoint — Must specify a success criterion for the primary endpoint.
SAE reporting timeline — Must state the timeline for SAE reporting (e.g. within 24 hours).
Informed consent — Section describing the informed consent process must be present.
DSMB/DMC — For controlled trials, data safety monitoring board/committee must be addressed.

Output: PASS if all checks are satisfied; otherwise FAIL with a short line per missing element. Run on the draft before ethics/regulatory submission; fix gaps and re-run until the check passes.

Output Excerpt

Excerpt from a generated protocol and sample validator report.

Protocol (excerpt):

## Primary endpoint
Overall response rate (ORR). Success criterion: ORR improvement of ≥15% vs control (alpha=0.05).

## Safety monitoring
AE and SAE defined per ICH E2A. SAE reporting: within 24 hours to sponsor; regulatory reporting within 7 days per applicable regulations. DSMB will review safety data every 6 months.

## Informed consent
Written informed consent obtained before any study-specific procedures. Process per ICH E6(R3) and local IRB/ethics committee requirements.

protocol_completeness_checker report (excerpt):

=== PROTOCOL COMPLETENESS CHECK (ICH E6(R3)) ===
Result: PASS

Document: protocol-draft.md
Section 'objectives' is present.
...
SAE reporting timeline is specified.
Informed consent section is present.
DSMB/DMC is addressed (for controlled trials).
Protocol meets ICH E6(R3) §6 completeness expectations.

Getting Started

Add your source materials to the project workspace (study design, eligibility criteria, regulatory requirements), then activate the Clinical Trial Protocol (ICH E6(R3) GCP) skill. The agent will guide you through study design, eligibility, interventions, safety, statistics, ethics, and running protocol_completeness_checker before IRB or regulatory submission.