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Validated Projects, part 4: Electronic Data Capture

Owned by Ashley O'Connor
Last updated: Mar 28, 2024 by Alyssa Hill
4 min read

Version: 2

Locking/e-Signatures

REDCap e-signatures and locking/unlocking functionalities are used to meet the data integrity requirements for FDA part 11 compliance for data entry instruments. When a data collection form has been locked for a particular record, the study team can apply an e-signature. By locking and e-signing a completed data entry record, the study team is acknowledging that the record cannot be edited further and has been authorized by the individual e-signing. When an e-signature is applied to a record, the user will be prompted to sign in using their REDCap login credentials to verify their identity.  

Note: any study team user with locking privileges (even those without e-signature rights) will negate the e-signature on a form when unlocking the record. Data changes may then be made to the record, and the form may be e-signed again.

  • Ensure this is considered when setting up user rights

  • Any case report form data that is related to the operational management of participant data or the participant data itself, should be locked and e-signed for storage. 

Locking and E-Signature Example

After checking both boxes, you can save and exit record, move on to the next form, etc. A pop-up will appear asking you to sign in, which is a verification of the user e-signing the data collected.

E-signature Verification Example

 

Enable Locking/e-Signatures for Users

In a project, navigate to "User Rights" under Applications in the left navigation bar. 

 

Select a user to edit rights, or click on a role to edit rights. 

 

In the Basic Privileges, select "Locking / Unlocking with E-signature authority", and save changes. All study personnel entering data should have rights to lock/unlock and E-sign, and only the PI and lead coordinator should have “Record Locking Customization” checked.

 

How to Manage Locking/e-Signatures

In a project, navigate to "Customize & Manage Locking/E-signatures" under Applications in the left navigation bar.

 

Under the "Record Customization Locking" tab, you may select which data collection instruments you wish to enable locking and/or e-signatures. For FDA Part 11 compliance and auditing reasons, any data entry or survey instruments without e-consent framework should have locking and E-signatures enabled (based on study teams defined procedures) with the following lock record custom text: “For Part 11 compliant studies, the E-signature check box and form locking box must both be checked.”

 These settings must be added to each project. They are not included in the eConsent REDCap Template.

 

Viewing Locked / e-Signed Forms

In the "Customize & Manage Locking/E-signatures" application, you may also view records in the project that have been locked or e-signed under the "E-signature and locking management" tab. 

 

Attestation

When consent forms are to be signed by the participant and study coordinator at separate times and/or locations, an attestation statement is required. This is used to document the study coordinator verifying and witnessing the signature of consent from the participant, and must include the signature date, IRB approval date, consent type and version given, acknowledgement of witness statement, study coordinator's name, participant's name, and study coordinator's signature. This is covered in the documentation of informed consent instrument must be used as a data entry instrument with locking/e-signatures enabled.

 

 

All fields and requirements for IRB documentation of informed consent can be tracked in the Documentation of Informed Consent report in the eConsent REDCap Template for CFR Part 11 Validated Project. It is located in the left navigation bar under “Reports”.

Fields in the report may be amended based on study requirements, but you must include the participant’s name, IRB approval date, date and version for each consent instrument, attestation date, and the study team representative’s name that filled out the form.

 

 

Other Validated EDC Functions

Several functions have been validated for the University of Utah CTSI REDCap instance and are listed below. Click each name to open links to relevant Knowledge Base articles.

 

 

 

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