Articles tagged with “good-clinical-practice-gcp”

Learn about entry-level clinical trial roles. This guide explains the Clinical Trial Assistant (CTA) and IHCRA positions, including responsibilities, salary, &

Explore the evolution from paper CRFs to eCRFs for clinical trials. Compare paper vs. electronic data capture (EDC) on data quality, cost, time, and compliance.

Learn about the database lock process in clinical trials. This guide covers its importance for data integrity, the steps involved, and key team responsibilities

Learn the complete query management process in clinical trials. This guide covers the workflow, high costs, and impact on data integrity for CROs and sites.

Learn how to manage protocol deviations in clinical trials. This guide covers classification, reporting, and prevention to ensure data integrity and GCP complia

Prepare for FDA BIMO inspections with this guide for clinical sites & CROs. Learn key strategies for documentation, QMS, staff training, & GCP compliance.

Learn the key clinical research roles. This guide defines the responsibilities of the Principal Investigator (PI), CRC, CRA, and Clinical Project Manager in tri

Explore the distinct roles in clinical trials. Learn the specific responsibilities of sponsors, CROs, and sites, from protocol design to regulatory compliance u

A complete guide to clinical trial site close-out. Our checklist covers data integrity, IP accountability, archiving, and regulatory compliance per ICH-GCP & FD