Overview of signatures

When a form or case report book is signed, it is expected that data entry is complete, source verification has been performed, and all queries are resolved and closed. The exact significance of a signature can vary from study to study. For example, a Principal Investigator (PI) can sign a form to indicate responsibility for the accuracy and completeness of the data, and a Clinical Research Associate (CRA) can sign the same form to indicate that the review is complete. Signatures can also mean form authorship or approval.

The language of the affidavit page on which a signer enters signature information indicates what the signature is intended to convey. Optionally, you can configure a brief definition or summary of the affidavit to appear in the Meaning column of the signature section on all forms that require signatures.