Creating a signature group

A signature group identifies users with permission to sign CRFs or Case Books. To be fully signed, a CRF must be signed by a representative of each signature group with which it is associated.

Note: You associate CRFs and Case Books with a signature group by using the SIGNCRF MedML tag. For more information, see Associating a form with a signature group.

To create a signature group, use the SIGNATUREGROUP tag.

<SIGNATUREGROUP
GROUPNAME="name"
[GROUPDESCRIPTION="text"]
[CRFTEXT="text"]
[CRFFILE="file"]
[CRFMEANING="text"]
[CRBTEXT="text"]
[CRBFILE="file"]
[CRBMEANING="text"]>
<USERREF* attributes/>
</SIGNATUREGROUP>

Using one or more USERREF child elements, add each user you want in the group to the SIGNATUREGROUP definition. These users must have the right to sign a CRF or Case Book, as appropriate. The USERREF element has a single USERNAME attribute, which specifies the user name of the user whom you are assigning to the group.

The following table describes the attributes of the SIGNATUREGROUP tag:

Attribute	Description
GROUPNAME	Name of the signature group. REQUIRED..
GROUPDESCRIPTION	Text describing the signature group. OPTIONAL.
CRFTEXT	Text of the Electronic Signature Affidavit displayed to members of the signature group when signing a CRF associated with the signature group. OPTIONAL; if used, specify either the CRFTEXT or CRFFILE attribute. If you do not specify either attribute, MedML Installer uses the text provided in a default CRF signing text resource. This resource has the UUID PF_DEFAULT_CRFAFFADAVIT. The text must include the stated intention of the signer for the electronic signature to be the legal equivalent of a handwritten signature. The text should include two %s characters to represent the user's first and last names.
CRFFILE	Path name of an HTML or text file containing the text of the Electronic Signature Affidavit displayed to members of the signature group when signing a CRF associated with the signature group. The path name must be relative to the directory from which you run the MedML Installer. OPTIONAL; if used, specify either the CRFTEXT or CRFFILE attribute. If you do not specify either attribute, MedML Installer uses the text provided in a default CRF signing text resource. This resource has the UUID PF_DEFAULT_CRFAFFADAVIT.
CRFMEANING	Text that summarizes the meaning of the signature on the CRF. This text is displayed on the Signature Details screen and in the list of completed and required signatures on the CRF. OPTIONAL. Required if either the CRFTEXT or CRFFILE attribute is specified. At least one combination of CRFTEXT or CRFFILE and CRFMEANING should be specified.
CRBTEXT	Text of the Electronic Signature Affidavit displayed to members of the signature group when signing a Case Book associated with the signature group. OPTIONAL; if used, specify either the CRBTEXT or CRBFILE attribute. If you do not specify either attribute, the MedML Installer uses the text provided in a default Case Book signing text resource. This resource has the UUID PF_DEFAULT_CRBAFFADAVIT. The text must include the stated intention of the signer for the electronic signature to be the legal equivalent of a handwritten signature. The text should include two %s characters to represent the user's first and last names.
CRBFILE	Path name of an HTML or text file containing the text of the Electronic Signature Affidavit displayed to members of the signature group when signing a Case Book associated with the signature group. The path name must be relative to the directory from which you run the MedML Installer. OPTIONAL; if used, specify either the CRBTEXT or CRBFILE attribute. If you do not specify either attribute, the MedML Installer uses the text provided in a default Case Book signing text resource. This resource has the UUID PF_DEFAULT_CRBAFFADAVIT.
CRBMEANING	Text that summarizes the meaning of the signature on the Case Book. This text is displayed on the Signature Details screen and in the list of completed and required signatures on the CRF used for signing a Case Book. OPTIONAL. Required if either the CRBTEXT or CRBFILE attribute is specified. At least one combination of CRBTEXT or CRBFILE and CRFMEANING should be specified.

Example

<SIGNATUREGROUP

GROUPNAME="Investigator Sigs"

GROUPDESCRIPTION="Investigator Sigs"

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. &#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. &#13;&#10;To this I do attest by supplying my user name and password and clicking the button marked Submit 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. &#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. &#13;&#10;To this I do attest by supplying my user name and password and clicking the button marked Submit below.&#13;&#10;"

CRFMEANING="Approval" CRBMEANING="Approval">

</SIGNATUREGROUP>