FDA finalises guidance on electronic source data in clinical trials

The FDA has published its finalised guidance document on electronic source data in clinical investigations, replacing draft guidance from late in 2012.

The guidance discusses:

  • Identification and specification of authorized source data originators
  • Creation of data element identifiers to facilitate examination of the audit trail by sponsors, FDA, and other authorized parties
  • Ways to capture source data into the eCRF using either manual or electronic methods
  • Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic data
  • Use and description of computerized systems in clinical investigations

This guidance is intended to be used together with the FDA guidance for industry on Computerized Systems Used in Clinical Investigations and FDA regulation on Electronic records and Electronic Signatures.