Signature Requirements For The eTMF

The requirements around signatures aren’t actually related to the electronic system – as the FDA has made clear in documents such as “Part 11, Electronic Records; Electronic Signatures — Scope and Application”, which states that 21 CFR Part 11 applies to:

“Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g. approved, reviewed, and verified).”

Signature requirements for TMF documents are established in several predicate rules related to Good Clinical Practice (GCP), and are the same for paper and electronic documents.

• The International Conference on Harmonisation (ICH) documents GCP in “Guideline for Good Clinical Practice E6 (R1)”.
• The US Food and Drug Administration (FDA) considers ICH GCP only a recommendation, and does not codify GCP in a single set of regulations. Instead, regulations are scattered through the Code of Federal Regulations (CFR) as documented on the FDA’s web page “FDA Regulations Relating to Good Clinical Practice and Clinical Trials.