Summary Sponsors receiving TMFs from CRO partners at the end of a study often experience quality issues when attempting to archive the TMFs. This post

On February 12, 2021, The UK Medicines & Healthcare Products Regulatory Agency (MHRA) published their annual GCP Inspections Metrics Report. This report covered the period

The MHRA Inspectorate Blog recently posted a post [i] discussing Corrective and Preventive Actions, the importance of root cause analysis, and what triggers inspectors to

FDA has issued a final guidance document on Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.  This draft guidance was first issued in 2018

I have recently published a peer-reviewed paper called “Optimize Your eTMF Strategy”, that you can read or download on the Journal for Clinical Studies (Volume

Electronic Data Capture (EDC) solutions have been used for a couple of decades now with more systems available today than one can count. From the

On July 17th, the FDA and Duke Margolis Center for Health Policy sponsored a workshop entitled “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical

Most every clinical trial today is utilizing some form of Electronic Data Capture (EDC). An EDC system allows for easier data collection, data checking and