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Signature invalidation
When a form or case book is signed, it is expected that data entry is complete and source verification has been performed . However, later information can result in data entry changes after the form or case book has been signed.
When this happens, the InForm application invalidates the previous signature or signatures and updates the signature listings and each form to indicate that the form or case book must be signed again.
Data that has been exported from the InForm application by using AutoCode or Central Coding functionality and reimported after coding has special invalidation considerations. Coded data is often designed to be hidden on a form; if the import of coded data invalidates a signature, it might not be possible to see which item caused the invalidation. Therefore, trial designers can specify whether imported data invalidates a signature.
When coded data is imported to a signed CRF or Case Book, invalidation of the CRF or Case Book is determined by the following:
- Visibility of the imported data.
- Setting of the INVALIDATIONLEVEL attribute of the SIGNCRF MedML component that associates a form or a Case Book with a signature group.
If the signing user can view the imported item, or if the INVALIDATIONLEVEL property is not specified, the signature is always invalidated.
If the trial is designed to base invalidation on the value of the INVALIDATIONLEVEL property, the invalidation decision for a CRF or a Case Book is based on the following rules:
- If the INVALIDATIONLEVEL value is USER, the signature is invalidated only if the signing user can view the imported item.
- If the INVALIDATIONLEVEL value is GROUP, the signature is invalidated only if at least one user in the signature group can view the imported item.
Note: Invalidation processing for Case Book signatures is invoked if coded data is imported to any CRF in the Case Book, whether or not the CRF requires a signature.
