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Associating a form with a signature group

You can associate CRFs and Case Books with signature groups. To associate a CRF or Case Book with a signature group, create XML for each form that requires an authorized signature, using the SIGNCRF MedML tag.

One form represents the Case Book for signature purposes. To designate a CRF as the Case Book signing form, specify its RefName as the FORMREFNAME in the SIGNCRF tag, and specify True as the value of the FINALCRF attribute.

The SIGNCRF tag has the following syntax:

<SIGNCRF
SIGNATUREGROUPNAME="name"
FORMREFNAME="name"
[RESETFORMSTATE="TRUE|FALSE"]

[INVALIDATIONLEVEL="USER|GROUP"]
[FINALCRF="TRUE|FALSE"]/>

The following table describes the attributes of the SIGNCRF tag:

Attribute

Description

SIGNATUREGROUPNAME

Identifies the authorized signature group. The signature group must have already been defined by a SIGNATUREGROUP tag.

REQUIRED..

FORMREFNAME

Specifies the RefName of the CRF. The form must have already been defined in the system. Note that screening and enrollment forms cannot be signed.

REQUIRED..

RESETFORMSTATE

Specifies the policy for handling already-signed forms when a new signature group is added. Values are:

  • TRUE—Indicates that the form must be approved by a member of the current signature group. This resets the state of fully-signed forms specified in the FORMREFNAME attribute to not fully signed. When a form is reset, the original signatures remain valid. However, the form must now be signed by a member of the newly-associated signature group as well.
  • FALSE (default)—Indicates that the form need not be re-signed when a new signature group is added.

OPTIONAL.

INVALIDATIONLEVEL

Specifies whether a signature should be invalidated when a data item is imported through Autocode or Central Coding processing after the form has been signed. Values are:

  • USER—The form or Case Book signature is invalidated if the user who signed can view the item being imported.
  • GROUP—The form or Case Book signature is invalidated if at least one user in the signature group can view the item being imported.

OPTIONAL. If you do not specify the INVALIDATIONLEVEL attribute, the InForm application invalidates the signature whenever the form is edited, either directly or by import. For more information, see Signature invalidation.

FINALCRF

Indicates whether the form specified in the FORMREFNAME attribute represents the entire Case Book for signing purposes. Note the following restrictions on the CRF designated as the Case Book signing form:

  • Only one form can be marked as FINALCRF
  • The final CRF cannot belong to more than one visit or to a repeating visit
  • The final CRF cannot be a repeating form

Values are:

  • TRUE—The form is the Case Book signature form.
  • FALSE (default)—The form is not the Case Book signature form.

OPTIONAL.

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