Georgetown Research Services
Georgetown Research Services

21 CFR Part 11 Docusign

Guidance for use of 21 CFR Part 11 Compliant Systems

What is 21 CFR Part 11?

The way clinical trials are conducted has necessitated the use of electronic systems, records, and signatures.  The use of electronic systems has not changed the requirement for trial results to be reliable, reproducible and accurate; therefore, it is essential to ensure the integrity and security of the electronic data generated in the course of a clinical trial.  The FDA’s Code of Federal Regulations (CFR), specifically 21 CFR Part 11, has outlined criteria for considering electronic records, electronic signatures:

In addition to the CFR, the FDA has provided guidance documents to assist institutions and study teams understand how to apply these criteria. 

When does it apply?

This regulation applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any FDA regulation for records requirements including predicate regulations.  

What does FDA-Regulated mean?

FDA regulated means the study involves clinical trials with drugs or devices as well as studies directly funded or supported by the FDA.

What are predicated rules?

Any FDA regulation that requires certain records to be maintained or submitted to the FDA.

For example:

GxP is a general term to refer to FDA’s regulations governing:

The GxP regulations are the Predicate Rules that describe FDA’s requirements for the conduct of research performed under these regulations.  If the Predicate Rules require certain records to be maintained or submitted to the FDA, and these records are in electronic format, then 21 CFR 11 applies.

For example:

FDA’s regulation 21 CFR 50.27: Documentation of Informed Consent, is a Predicate Rule, which states the following:

“… informed consent shall be documented by the use of a written consent form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy shall be given to the person signing the form…”

If a researcher conducting an FDA-regulated study wants to document a subject’s informed consent by obtaining an electronic signature and date from a subject or subject’s legally authorized representative, then the electronic system used to capture the electronic signature and date must meet the requirements of 21 CFR Part 11.

What electronic records require 21 CFR Part 11 Compliance?

21 CFR Part 11 Compliance applies to records needed for FDA to reconstruct a clinical investigation that are maintained and archived under any of the FDA rules (predicate rules) in electronic format in place of paper format or where the electronic record is relied on to perform regulated activities. Additionally, records submitted to FDA in electronic format under any of the FDA rules (predicate rules), even if such records are not specifically identified in FDA regulations.

Specific examples of Clinical Trial Documents that fall under Part 11 include:

How do I obtain a 21 CFR Part 11 Docusign Account and complete the required training?