Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  • The printed name of the signer.

  • The date and time of when the signature was executed.

    • Note: Time of signature will be tracked within REDCap logging and does not need to be recorded on the form itself.

  • The meaning (review, approval, responsibility, authorship, etc) associated with the signature. 

    • Note: This requirement is covered by the certification of the signature by the participant, as well as the signature of the coordinator on the attestationdocumentation of informed consent. 

How to Implement Electronic Consent in REDCap

Researchers must follow procedures to meet compliance as outlined in the eConsent REDCap Template project template. Fields and forms may be ammended based on study requirements. For FDA regulated studies, the e-consent and attestation documentation of informed consent instruments should be used as is.

...