Hi!
Which is the latest FDA guidance for computerized systems used in GCP Clinical Trials?
This: Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS: (1999)
Or This: Guidance for Industry Computerized Systems Used in Clinical Investigations (2007)
I guess its not clear that that 2007 guidance supersedes the 1999 once, because of the difference in their titles.
Which is the latest FDA guidance for computerized systems used in GCP Clinical Trials?
This: Guidance for Industry - COMPUTERIZED SYSTEMS USED IN CLINICAL TRIALS: (1999)
Or This: Guidance for Industry Computerized Systems Used in Clinical Investigations (2007)
I guess its not clear that that 2007 guidance supersedes the 1999 once, because of the difference in their titles.