If a commerically available system like SAS, STATA, R or others is used for analysis, or a GCP compliant data entry system like Inform, OpenClinica or Infermed is utilised in a study, is there a requirement for sponsors to undertake addtional validation of the systems beyond what is done by the manufacturers? We are being asked to prepare detailed validation documentation on a study by study basis for all systems that are used in that particular study, regardless of their origin, and it seems rather excessive and time consuming. We are told it is required by the MHRA.

It also seems rather pointless if the people requesting and reviewing the detailed information have a minimal grasp of analysis or computer systems and I suspect if this becomes commonplace, it will do more harm than good to academic research.