Related Documents

In the eTMF, it is essential to be concerned with what is present and what is missing. It is important to audit the eTMF for essential documents that may or may not be present, and it is helpful if the system can tell you which missing documents may be related to a collected one. In 10.5, enhancements to the Related Document feature will allow the creation of named document relationships of specific types, for example, Translations and Notes to File. Additionally, document relationships may now be created automatically based on configuration. This will allow a full set of related documents to show for a variety of completeness scenarios:

  • 1572s forms can show all the related or missing CVs, Medical Licenses, and Financial Disclosure Forms.
    • Protocol Amendments can show all the related or missing signature pages and signoffs.
    • Translations of documents can show, indicating their language.
    • Related Notes to Files can show for certain documents.
    • Other useful relationships may be easily configured.

Related Documents - Manual and Automatic Relationship

When performing indexing, related documents need to be related to each other in the eTMF for easy filing and to make it easier to find the related documents as needed. Trial Interactive v10.5 allows for document storage rooms to be set up with expected document relationships in advance. Since the relationship is already established, navigating to a related document or placeholder is simplified even further by adding the ‘Related’ tab of the metadata panel.

The ’Related’ tab, available in the document and audit modules, shows placeholders for required documents and each required document's relationship type and metadata. Users can also add a new manual relationship, compare documents, link and unlink documents, and open a document in a new window.

Similarly, it is important during a completeness audit for auditors to be able to view not just related documents but placeholders for required documents as well.

Support Related Documents as Relationships in Required Document

Frequently, audits are set up in TI rooms for specific document types. It is also the case that documents related to those specific document types should be reviewed as well for the sake of completeness. TI v10.5 enables users to easily review a designated document as well as those documents to which it is related.