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Electronic Consent: in the scope of REDCap, electronic consent refers to the electronic capture of a ‘wet' signature from a participant using the e-consent framework. This requirement covers the ‘Electronic Signature’ definition found in the FDA part 11 regulations.
Electronic Record: any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.Electronic Signature (E-Signature): in the scope of REDCap, an E-signature refers to the individual verifying the data being captured electronically, digitally signing, and authenticating their identity. This requirement covers the ‘Digital Signature’ definition found in the FDA part 11 regulations.
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Security features that limit user access and their privileges must be in place. Some examples of these security features include making sure users have unique usernames and passwords, being able to detect and prevent unauthorized system access, and locking compromised accounts.
The two three primary tools for enforcing limited system access:
User passwords to access a system
Two-factor authentication during log in (DUO)
Program time-outs which lock the system when not in use for an extended period of time (30 minutes)
User Roles
It is up to the discretion of the project PI in conjunction with the study team to set up User Rights & Roles in a project. In order for a study to be Part 11 Compliant, project sponsor / investigator roles and responsibilities must be clearly articulated to provide awareness to sponsors and investigators of responsibilities to adequately conduct clinical trials.
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