Guided Notes

GCP & Regulations for Data Managers

ICH E6 Good Clinical Practice (including E6(R3)), 21 CFR Part 11 electronic records, data integrity (ALCOA+), informed consent, privacy (HIPAA, GDPR) and inspections.

Good Clinical Practice (GCP)

Slide 1 / 5

GCP is the international ethical and scientific quality standard for trials (ICH E6). Its goals: • protect the rights, safety and well-being of participants, • ensure the credibility and accuracy of trial data. ICH E6(R3) (finalized in 2025) emphasizes quality by design, risk-proportionate approaches, fit-for-purpose systems and data governance — directly relevant to data management.

← Clinical Trial Design Essentials