ePSF vs eISF: Why Pharmacy Documentation Needs Its Own File
The pharmacy site file is not a folder inside the investigator site file. It is a separately owned, separately held, separately inspected record, and merging the two is what costs sites at inspection. This guide explains why ePSF and eISF stay distinct, what belongs in each, and why the separation still matters once both go digital.
Why Do CROs Require a Standardised eTMF?
Clinical trials involving multiple CROs operate across different TMF structures, systems, and SOPs. A standardised eTMF brings all CROs under one controlled framework (same structure, classification, and workflows), enabling real-time completeness tracking, continuous sponsor oversight, and consistent inspection readiness throughout the study lifecycle.
How AQ eISF and ePSF Support Multi-Site Documentation Governance Across a CRDC Network?
A CRDC research network distributes clinical trial delivery across multiple NHS sites while concentrating governance accountability at the hub. AQ eISF and ePSF are built to give the hub that control: connecting site documentation, pharmacy accountability, and quality governance into one inspection-ready operating layer across every participating site. Key Takeaways: The Documentation Control Problem Specific […]
What is ePSF in Clinical Trial Data Management?
An Electronic Pharmacy Site File (ePSF) is a digital repository, designed to support 21 CFR Part 11 requirements, within a Clinical Trial Management System (CTMS) that manages investigational product documentation, pharmacy records, and accountability data across clinical trials. It standardises how pharmacy-controlled records are created, organised, authorised, and audited in alignment with ICH-GCP requirements. In […]
CTMS vs eTMF: What Is the Difference?
A CTMS runs a clinical trial while it is happening. An eTMF holds the evidence that it happened that way, for 25 years after the trial concludes under the amended UK regulations. This guide compares the two on retention, structure and inspection, and gives six questions that route any record to the right system.
What is an eTMF in Clinical Trial Research?
An electronic trial master file (eTMF) is the validated system that holds the essential records of a clinical trial and shows, for every record, who filed it, who approved it and what changed. Sponsors and contract research organisations (CROs) use it to prove a trial was run to Good Clinical Practice. AQ eTMF is the […]
What is eISF: Electronic Investigator Site File in Clinical Research
An electronic investigator site file (eISF) is the validated system a research site uses to hold its essential trial records under version control, role-based access and a full audit trail. It holds the copy of the trial record that belongs to the investigator and stays under site control. AQ eISF is the site file module […]
