ICH GCP
Skill packages tagged with “ICH GCP”
Clinical Trial Protocol (ICH E6(R3) GCP)
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).
eCTD Cross-Module Verifier
Verify consistency and data integrity of eCTD pharmaceutical dossiers. Cross-checks Module 2 (Summaries) against Module 5 (Clinical Study Reports) to ensure study references, p-values, N-counts, endpoints, and safety data are aligned before regulatory submission to FDA, EMA, or PMDA.