We were a bit surprised when several GCP inspectors (similar to FDA
inspectors) approached us and told us that the system we are using
(OpenClinica Enterprise) is not GCP compliant in respect of Investigator
holding an independent copy of data (Page 10 in European Medicines
Agency “Reflection paper on expectations for electronic source data and
data transcribed to electronic data collection tools in clinical trials”
and Page 7 in FDA “Guidance for Industry – Electronic Source Data in
In order to meet the requirements a contemporaneous certified copy of the data should be retained at the investigator site in addition to the record maintained on a central server.
During a recent audit we required to do a complete validation also for protocol 2 due to the fact that the EMA regulations require a full validation for each protocol. Do you agree or disagree with the auditor?
Christian, are you saying that a new Validation Plan, IQ, OQ, PQ, Test Plan, Test Report, Validation Report and all 12 standard requirement must be tested and documented for each study protocol?
Surely we do as well but they tests are concentrating on the changes, i.e. the modifications. We do not retest any of the unchanged CRF's and neither do we retest the operating system installation and configuration.