Statisticians in the Pharmaceutical Industry - Working Parties Working Parties Members of PSI are encouraged to organise working parties when the need to answer specific current issues arises. Thus at any time there could be several active ad-hoc groups working over, and reporting back after one or two years. This working party was originally formed in 1995 in order to develop an industry wide guideline on computer systems validation in clinical research. The guideline was published in 1997, and is available to download via the PSI web site , or can be purchased from the PSI office. The WP continues to work on raising the awareness of the need for CSV, developing and running an ACDM sponsored training course, and working to ensure that the guideline continues to reflect industry requirements.
Work is currently underway to develop an updated version of the guideline.