The draft guidance provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under part 11 in clinical investigations of medical products. The draft guidance clarifies, updates, and expands upon recommendations in the 2003 part 11 guidance for recommendations that pertain to FDA-regulated clinical investigations conducted under parts 312 and 812. Thus, the guidance is limited to the scope and application of part 11 requirements to such clinical investigations.
The goals of the draft guidance are to clarify and update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations and to encourage and facilitates the use of electronic records and systems to improve the quality and efficiency of clinical investigations.
The guidance discusses the procedures that may be followed to help ensure that electronic records and electronic signatures meet FDA requirements and are considered to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. The guidance also discusses the use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations conducted under parts 312 and 812.