Over the last decade, there has been a significant increase in the use of electronic systems for capture and handling…
The MHRA GCP Inspectorate Symposium was held recently in Leeds, UK. There was an extremely positive atmosphere and great opportunities…
In March, the UK and EU negotiating teams reached agreement on the terms of an implementation period that will start…
GCP inspection findings/observations in clinical trials forming the basis for an application for marketing authorizations for new medicinal products or…
According to the updated ICH GCP, section 5.2.2: The sponsor should ensure oversight of any trial-related duties and functions carried…
The European Medicines Agency (EMA) has issued a draft guideline, which lays down the principles for management of the IMP…
During a period of one year from 2016 to 2017, the UK GPvP (Good Pharmacovigilance Practice) Inspectorate conducted 36 inspections…
The EU GDPR (General Data Protection Regulation), effective from 25th May 2018, replaces the Data Protection Directive 95/46/EC, is designed…
The investigator should agree to archive the documentation (both electronic and paper-based records) during the retention period as required according…
We are using eTMF (electronic Trial Master File) more and more in clinical trials, but the sponsor eTMFs are not…