SignatureGroup

Purpose

Specifies a set of users who can sign case books or CRFs.

Notes:

You cannot create signature groups in the user interface. You must use the Central Designer application or MedML to define signature groups.

The only way to remove a user from a group is through the Admin function of the InForm application. You cannot remove a user by running the MedML Installer utility.

Syntax

<SIGNATUREGROUP

GROUPNAME="name"

[GROUPDESCRIPTION="text"]

[UUID="id"]

[LANGUAGE="name"]

[CRFTEXT="text"]

[CRFFILE="file"]

[CRFMEANING="text"]

[CRBTEXT="text"]

[CRBFILE="file"]

[CRBMEANING="text"]>

<USERREF* attributes/>

</SIGNATUREGROUP>

Attributes

GROUPNAME="name"

Name of the signature group. Required.

GROUPDESCRIPTION="text"

Text describing the signature group. Optional.

UUID="id"

Universally Unique Identifier; a string that identifies the component uniquely across all studies, study databases, and machines. Optional.

LANGUAGE="name"

Code for the culture and language used to display text values. If you do not include a LANGUAGE attribute, the default is the installed default product locale. Required if text strings are translated (if a TRANSLATIONS element is included as a child of the study component definition).

Note: Relying on the default product locale is not recommended, because the default product locale can be changed.

CRFTEXT="text"

Text of the Electronic Signature Affidavit displayed to members of the signature group when signing a CRF associated with the signature group. Specify either the CRFTEXT or CRFFILE attribute. If you do not specify either attribute, the MedML Installer utility uses the text provided in a default CRF signing text resource. The text must include:

What the signature means. For example, attestation to the accuracy of the data provided in the CRF.
Stated intention of the signer for the electronic signature to be the legal equivalent of a handwritten signature.

Optionally, the text can include string substitution characters (%s) to represent the user's first and last names. See the Example section. You can use the TRANSLATIONS attribute to provide translations of the attribute value. Optional.

CRFFILE="file"

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 utility. Specify either the CRFTEXT or CRFFILE attribute. If you do not specify either attribute, the MedML Installer utility uses the text provided in a default CRF signing text resource. Optional.

CRFMEANING="text"

Text that summarizes the meaning of the signature on the CRF. This text is displayed on the Signature Details page and in the list of completed and required signatures on the CRF. You can use the TRANSLATIONS attribute to provide translations of the attribute value.

Note: The text for the meaning of a signature is stored in the language of the site where the CRF was signed. The language does not change if a subject is transferred to another site with a different site study locale.

CRBTEXT="text"

Text of the Electronic Signature Affidavit displayed to members of the signature group when signing a case book associated with the signature group. Specify either the CRBTEXT or CRBFILE attribute. If you do not specify either attribute, the MedML Installer utility uses the text provided in a default case book signing text resource. The text must include:

What the signature means. For example, attestation to the accuracy of the data provided in the form.
Stated intention of the signer for the electronic signature to be the legal equivalent of a handwritten signature.

CRBFILE="file"

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 utility. Specify either the CRBTEXT or CRBFILE attribute. If you do not specify either attribute, the MedML Installer utility uses the text provided in a default case book signing text resource. Optional.

CRBMEANING="text"

Text that summarizes the meaning of the signature on the case book. This text is displayed on the Signature Details page and in the list of completed and required signatures on the CRF used for signing a case book. You can use the TRANSLATIONS attribute to provide translations of the attribute value.

UPDATE="true|false"

Perform an incremental update for the specified signature group by modifying only the properties that you specify.

Children

Zero or more Userref definitions. Each Userref refers to a previously created User definition that identifies one InForm user.
Zero or one Translations definition that specifies a set of translated strings for the translatable attributes of the study component. A Translations element must include one or more Translation definitions. Each Translation element represents the translation of one attribute of a study component into the language of one locale. The Translations element must be the last child element in the study component definition. In a SignatureGroup definition, you can translate the CRFTEXT, CRBTEXT, CRFMEANING, and CRBMEANING attributes. If you translate any attributes, include translation definitions for all translatable attributes that are part of the study component definition.
Note: Translations are not supported for the CRFFILE and CRBFILE attributes.

Example

In the following SignatureGroup, users dobrien and lhill can sign.

The following SignatureGroup definition illustrates the inclusion of the signing text for a CRF. The two %s characters specify that the displayed Electronic Signature Affidavit should include the user's first and last names. Note that the tag attributes must be in single quotes because they appear within the double quotes of the CRFTEXT attribute. Additionally, the SignatureGroup definition includes the definition of a translation string for the CRFTEXT attribute.

<SIGNATUREGROUP GROUPNAME="PI Signature" LANGUAGE="en-US"

CRFTEXT="By my dated signature below,

I, %s %s, verify that this case report form accurately displays

the results of the examinations, tests, evaluations and

treatments noted within.

Pursuant to Section 11.100 of Title 21 of the Code of Federal

Regulations, this is to certify that I intend that this

electronic signature is to be the legally binding equivalent

of my handwritten signature.

To this I do attest by supplying my user name and password and clicking

the button marked &t b >Submit below."

CRFMEANING="Approval">

<TRANSLATION NAME="CRFTEXT" LOCALE="fr-FR"

DISPLAYTEXT="Par ma signature datée ci-dessous,
Moi, %s %s, je confirme que ce cas formulaire de rapport affiche avec précision
les résultats des examens, des tests, des évaluations et des
constatées dans les traitements. 
Conformément à la Section de 11,100 Titre 21 du Code of Federal
Règlement, il s'agit de certifier que j'ai l'intention que ce
signature électronique doit être juridiquement contraignant équivalent
de ma signature manuscrite. 
Pour cela, je ne témoignent par la fourniture de mon nom d'utilisateur et mot de passe et cliquez sur
le bouton Submit ci-dessous.

<TRANSLATION NAME="CRFMEANING" LOCALE="fr-FR"

DISPLAYTEXT="Approbation"/>

</TRANSLATIONS>

</SIGNATUREGROUP>