MHRA share a summary of a two day workshop on Electronic Data Integrity: a current hot topic across GCP, GCLP and GMP


The widespread use of electronic systems being utilised to capture source data and manage clinical trials provides plenty of opportunities for issues to arise especially as these systems are relatively new within the clinical trial world.

Nine Inspectors from the MHRA have recently attended two days of technical training on Data Integrity covering a variety of topics including: GCP regulatory requirements and expectations, principles on inspecting for data integrity, and computerised system validation processes, including cloud computing. This topic is relevant to all of us as we head towards more electronic technology in all areas of clinical research including GCP, GCLP and GMP. This link provides an excellent summary of the issues discussed amongst the inspectors and are relevant to our work.