21 CFR Part 11, Electronic Signatures, & OpenClinica

Organizations that seek to submit their clinical trial results to the FDA must comply with 21 CFR Part 11: a key set of United States government regulations governing the use of electronic systems in clinical trials. Despite the fact that the government has issued guidance to try and clarify interpretation of these regulations, many people continue to have varying opinions on how software can/should best support 21 CFR Part 11 compliance.

Before I go any further I want to make sure readers understand that software itself can neither be compliant nor non-compliant. It is the implementation and use of software that determines actual compliance. Therefore, one could envision a system without a lot of native features designed to support 21 CFR Part 11 and achieve compliance through the application of Standard Operating Procedures (SOPs) and other controls. Conversely, one could conceive of a system that inherently better supports compliance through specific features.

As a member of the core OpenClinica development team, I have been involved in tackling one of the key pieces of 21 CFR Part 11 guidance that causes a considerable amount of confusion: electronic signatures. As a refresher, electronic signatures are a system feature used to ensure that actions taken by users of a system are attributable in a legally binding manner. 21 CFR Part 11 looks at System Controls, Signature Controls, and Password Controls as components of electronic signatures.

The forthcoming release of OpenClinica (version 2.5) will offer new ways of verifying that the data being provided for a subject is Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA).

Different users in the context of OpenClinica will need to verify the data they are providing are truly accurate and complete. One of the users may have a data entry role. In order to show the data being provided truly is ALCOA this user must enter their password before completing data entry. This will also ensure the user entering the information is in fact the same person that logged into the application in the first place.

An investigator in OpenClinica will need to verify all data are accurate and complete for a subject’s event, or the complete subject “case book.” OpenClinica will allow the user to sign event by event whereby the investigator is stating that all of the information in the CRFs for each event contains original and accurate data. Before signing for the subject’s event or case book, the investigator will be allowed to go through each one of the CRFs to make sure all discrepancies have been cleared up, and all the data are complete.

Every step a user takes to sign a CRF, an event, or the subject case book is being audited in the application so there will always be a record of when each action took place.

This has been a brief explanation of how OpenClinica 2.5 will further support clinical trials where the results will need to be provided to the FDA. The new electronic signatures feature allows users who are implementing and using the software to become more compliant with 21 CFR part 11 requirements.

2 thoughts on “21 CFR Part 11, Electronic Signatures, & OpenClinica

  1. Thanks for the clarification. I read a line about discrepancies…

    “Before signing for the subject’s event or case book, the investigator will be allowed to go through each one of the CRFs to make sure all discrepancies have been cleared up, and all the data are complete”

    Is discrepancy the same as Adverse Events? If not, how do Openclinica report serious Adverse Events.

    Thanks.

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