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Anyone conducting a clinical trial that uses electronic records in place of paper records, including electronic signatures that are intended to be the equivalent of handwritten signatures.
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Definitions
Digital Signature: an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verifiedElectronic 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 : a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten 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.
View the FDA Title 21 Chapter I Subchapter A Part 11 regulations here.
User Rights
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.
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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 important responsibilities to adequately conduct clinical trials.
It is important to create the following separate roles and their designated rights in REDCapeach project. The following examples would meet Part 11 compliance for separation of concerns:
Administrator
Auditor / Monitor
Data Entry Analyst
Principle Investigator
Study Coordinator
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