GCP
Skill packages tagged with “GCP”
Clinical Trial Protocol (ICH E6 R3)
Draft clinical trial protocols compliant with ICH E6(R3) and ICH E8(R1). Covers study design, objectives, endpoints, eligibility criteria, estimand framework (ICH E9(R1)), statistical analysis plan, safety monitoring, IDMC, RBQMS, and regulatory submission requirements (FDA IND / EU CTR 536/2014 via CTIS) for all study phases and therapeutic areas.
ICH E6 Investigator Brochure (IB) Author
Author and maintain ICH E6(R3)-compliant Investigator Brochures for investigational medicinal products, including Reference Safety Information, annual update/change-control summaries, and investigator-facing risk digests aligned with FDA IND, EU CTR, CIOMS V, and ICH E2A expectations.
ICH
E6(R3)
Investigator Brochure
Clinical Trials
GCP
Pharmacovigilance
Regulatory Writing
FDA
EU CTR
RSI
SUSAR
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