Tag: ICH E6(R2) archiving

GCP Requirements for Clinical Data Archiving: A Step-by-Step Guide

July 8, 2025

GCP Requirements for Clinical Data Archiving: A Step-by-Step Guide GCP-Compliant Clinical Data Archiving: Requirements and Best Practices Archiving clinical trial data is a critical activity that ensures long-term integrity, traceability, and compliance with global Good Clinical Practice (GCP) regulations. Whether storing paper source documents, digital records, or an electronic Trial Master File (eTMF), sponsors and…

Clinical Data Management, Data Archiving

Archiving Essential Documents at the Site During Clinical Trial Close-Out

June 15, 2025

digi

How to Archive Essential Documents During Clinical Trial Close-Out At the conclusion of a clinical trial, one of the most critical responsibilities for both the sponsor and site is the archiving of essential documents. These documents serve as verifiable evidence that the trial was conducted in accordance with Good Clinical Practice (GCP), regulatory requirements, and…

Site Close-Out Visits, Site Management and Monitoring