Clinical Research - Computer Sytem Validation Working Party
Committees & Groups

Clinical Research - Computer Sytem Validation Working Party


Formed in August 1995, the original title was the ACDM/PSI Working Party. It has since extended it's scope beyond data management and statistics, so changed it's name to Clinical Research Computer Systems Validation Working Party.

Since it's inception, with an original remit from the ABPI of providing industry-wide guidance on computer system validation, it has now produced two versions of the widely used and regulatory accepted, guideline 'Computerised Systems Validation in Clinical Research - a practical guide' which is available for purchase via ACDM offices.

It has also run numerous cross-industry forum sessions designed to advance overall understanding in specific aspects of system validation and quality, and developed and presented CSV training materials to a wide range of audiences including data managers, statisticians, programmers, IT professionals and regulatory inspectors. It continues with its remit of developing best practices across the industry via discussion forums and publications. 

The Working Party is now working on a new publication which is hoped ot be available ain early 2014.  Entitled Validation and Management of eClinical Systems in Collaborative Clinical Trials - A Practical Guide, this publication addresses the need for effective collaboration between industry and academic research and provides an effective collaboration model.

If you would like more information please contact the Working Party direct at collaborationguide@gmail.com.