Creating the text of a signing affidavit
To be in compliance with 21 CFR 11, electronic signatures must include:
- Full name of the signer.
- Date and time of the signature.
- Meaning of the signature, for example, review, approval, responsibility, authorship.
The InForm application captures the user name and password of the signer and the date and time of signature and records them in the signature history which is displayed on the Signature Details screen. To complete the compliance, make sure that:
- The First Name and Last Name of each person who will be signing CRFs are that person’s full name. This insures that the signature history bears the signer’s full name.
- The text of the signing affidavit includes the signer’s full name. To do this, include two %s variables in the text, one for the first name of the user and the other for the last name.
- The text of the signing affidavit includes the meaning of the signature.
The signing affidavit is a text file that can contain HTML characters for formatting and emphasis. The text of a sample signing affidavit follows for both a CRF and a CRB.
Example
CRFTEXT="By my dated signature below, I, %s %s, verify that this case report form accurately&#13;&#10;displays the results of the examinations, tests, evaluations and treatments noted within.<BR><BR>&#13;&#10;Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this&#13;&#10;is to certify that I intend that this electronic signature is to be the legally&#13;&#10;binding equivalent of my handwritten signature.<BR><BR>&#13;&#10;To this I do attest by supplying my user name and password and clicking the button marked <B>Submit</B> below.&#13;&#10;"
CRBTEXT="By my dated signature below, I, %s %s, verify that all case report form pages&#13;&#10;accurately display the results of the examinations, tests, evaluations and treatments&#13;&#10;performed on this patient.<BR><BR>&#13;&#10;Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this&#13;&#10;is to certify that I intend that this electronic signature is to be the legally&#13;&#10;binding equivalent of my handwritten signature.<BR><BR>&#13;&#10;To this I do attest by supplying my user name and password and clicking the button marked <B>Submit</B> below.&#13;&#10;"