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# Electronic Signatures Addressed in Clinical Trial Q&A
- URL: https://www.fdaweb.com/electronic-signatures-addressed-in-clinical-trial-q-a/
- Published: 2020-06-05T12:00:00.000Z
- Updated: 2026-09-14T16:17:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146942

FDA has added a new section to a clinical trial guidance on 21 CFR Part 11 compliance for electronic systems used to generate electronic signatures on clinical trial records. The added content is contained in a question-and-answer appendix in the guidance titled “[Conduct of Clinical Trials of Medical Products during Covid-19 Public Health Emergency](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZP9Q8-2FvNLx46yPba7RT8XNZJ6mKpJKVdg76ygj8CeWFGBWLktSvq1ip88p3l8M8TpBF-2FVFuI-2BrfFVdkPmYY-2BSNsIQoGXfAUuwySYXII6e8QJtdPb-2BHM5a9kC5o6e-2FClJCsqxyjjm0yUAWaemgBQ2vkYIMvVP2K67ZoYBmWtJodt8-2BAA2ZbnUUMt2JHs3if5z3MUZbmBRxXIhJPxNoALRsIQ-3D7oI1%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMig1ginQj2gs-2B15GFNruexk3ooOFxk0sNylrLi9EE3xmHHPp2w-2BZdwM-2BxgA0OcVVsnpszmHNS3hyfUXoNlYS7TQZZgzQfZ3CFSQ-2BhbnB8sIUoZgovrJ3gwC-2Fc80B-2F62HWn-2FpsyzEbhwjdW4aD4s42-2FfX5ZuhAu9Dlb-2BNHblnDZqLr-2BX2E6KgD5A25Ule8yCRF0Mwvc4b32mgquUXs-2BRISPm4TArTnj1K0R3q6rAxtGSHfQAGv7Lo3v-2BhW2vDIW-2Fcz5F2vtBqFRq-2BbV2v9SpQBXni6qaC3brh9G6LYaTxWHBPyw-3D&ref=fdaweb.com).” The document also cites the [Covid MyStudies App](http://email.prnewswire.com/ls/click?upn=3slWLw94I3jq-2B-2FedjFNgZLJsxjG040N2rwPdqKli79AKNtVlQ264TepkWKZaiUpbqh1dP3OoTw5fVscTsYumD9gZ13EuUJTVujkQ9ZQvgiWj40DWEZrr25v7F9mO412oMXo1%5FYT-2BgtM2gIoe0GzKRNjnJV0GfiU11vns8m-2BZpwCt0-2BFBxp0Mttf-2FYcRTcT5Y8GMig1ginQj2gs-2B15GFNruexk3ooOFxk0sNylrLi9EE3xmHHPp2w-2BZdwM-2BxgA0OcVVsnpszmHNS3hyfUXoNlYS7TQZZgzQfZ3CFSQ-2BhbnB8sIUoZgovrJ3gwC-2Fc80B-2F62HWn-2FpsyzEbhwjdW4aD4s42-2FfX7hRn8Pix-2B2j3Z8oKgfjQgFWJWtb468uKEwEYB9LxMAAToV-2BH-2FrBPapkuecVfk7ul7OjA8jOetvWykCNDdWdWtVKqNOzzp8yb1UrNxYrRRnatkqGBryZ4SYaiKfvaTp1p5gBfO-2BaOc2kIZ3AvpT4JEU-3D&ref=fdaweb.com) as an example of an electronic method for obtaining informed consent securely when face-to-face contact is not possible. Additionally, the document elaborates on an existing question-and-answer about four remote clinical outcomes assessments — performance outcomes, interview-based clinician-reported outcomes, patient-reported outcomes, and observer-reported outcomes.

Regarding electronic signatures, FDA says that systems used to generate them on clinical trial records, including informed consent documents, must comply with the requirements outlined in Part 11 regulations when applicable. “FDA is aware that there are multiple commercial off-the-shelf (COTS) software systems providing electronic signature services for clinical trial records,” the guidance says. “FDA does not certify individual electronic systems or methods to obtain Part 11 compliant electronic signatures, but COTS vendors may be able to provide sponsors and other regulated entities with information regarding whether their systems are Part 11 compliant. When such information is unavailable from the vendor, and a Part 11 compliant electronic system is required, sponsors and other regulated entities must take other steps to ensure the electronic system or software in use is Part 11 compliant.”

Additionally, FDA has made the Covid “MyStudies App” available in the Apple App and Google Play stores as a platform enabling investigators to obtain informed consent securely from patients when face-to -face contact is not possible or practical. “To facilitate free use of the app during the public health emergency, FDA intends to fund the technical assistance required to operate the Covid MyStudies App, which will be provided by the Harvard Pilgrim Healthcare Institute, as resources permit,” the agency says. For more information, visit here: [https://www.fda.gov/drugs/science-and-research-drugs/covid-mystudies-application-app](https://www.fda.gov/drugs/science-and-research-drugs/covid-mystudies-application-app?ref=fdaweb.com).