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Significance of a signature

Generally, signing a form or case book is done with the expectation that the form or case book is complete, and data is not expected to change. The exact significance of a signature can vary from trial to trial; for example, a Principal Investigator (PI) could sign a form to indicate responsibility for the accuracy and completeness of the data, and a CRA could sign the same form to indicate that the review is complete. Additional meanings of a signature could include authorship or approval of a form.

The language of the affidavit page on which a signer enters signature information indicates what the signature is intended to convey. A brief definition or summary of the affidavit might appear in the meaning column of the signature section on all forms that require signatures.

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