FDA Draft Guidance on Electronic Source Documents in Clinical Trials
This post was written by Paul Sheives.
FDA has published a draft guidance entitled “Electronic Source Documentation in Clinical Investigations.” The document is intended to address the capture, use, and archive of electronic data in clinical trials. The document also provides the agency’s view on ensuring the reliability, quality, integrity, and traceability of electronic source data and source record maintained at the clinical trial site for FDA inspection. More specifically, the guidance seeks to address: (1) the identification of the data element as the basic unit of information in the eCRF;( 2) the description of the source of each data element; 3) information about the electronic creation, modification, transmission, and storage of source data and documents; (4) investigator responsibilities with respect to reviewing and archiving data; (5) the transmission of data to the sponsor and/or other designated parties; and (6) the preservation of data integrity. FDA is accepting written comments on the draft guidance until April 7, 2011.
