Who needs to follow 21 CFR part 11 compliance?
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.
Part 11.3 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 verified.
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.
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.
The two primary tools for enforcing limited system access:
User passwords to access a system
Program time-outs which lock the system when not in use for an extended period of time
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 important responsibilities to adequately conduct clinical trials.
It is important to create the following roles and rights in REDCap:
Administrator
Auditor / Monitor
Data Entry Analyst
Principle Investigator
Study Coordinator
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