Leveraging custom metadata fields helps capture additional information about a TMF document and facilitates better record keeping. This article describes how to configure metadata fields at both the study level and document level, set metadata values, and view document metadata within Egnyte eTMF.
Understanding Study Vs Document Metadata
Configuring Custom Study Metadata
Assigning Values to Custom Study Metadata Fields
Configuring Custom Document Metadata
Assigning Values to Document Metadata Fields
Viewing Study And Document Metadata
Understanding Study Vs Document Metadata
Careful consideration is important when determining which custom metadata fields to add to an Egnyte eTMF environment, distinguishing between fields appropriate for the document level and those for the study level.
Fields added at the study level will cascade their assigned value to all documents associated with that study. For example, study-level metadata might include a Product field to capture the drug, device, or treatment that is the subject of the study. All documents in a given study will have the same Product value.
Fields added at the document level can have different values for different documents within the same parent study. For example, a Document Date field to capture the most meaningful date for each document will have different values for different documents within a study.
Configuring Custom Study Metadata
Custom metadata can be configured by navigating to Collaborate > Settings > Metadata Tags > Configuration.
- Click Add New Section and give the section a name that clearly indicates it will contain Study Metadata.
- Be sure to enable the toggle next to Enable metadata inheritance for this metadata section so that values assigned at the study level will be applied to all child documents. Any number of Study-Level fields can be added, with changes saved upon completion.
- Save the changes and then click on Continue in the confirmation dialog popup.
Assigning Values to Custom Study Metadata Fields
After custom study metadata fields are added as outlined above, values can be populated by accessing the parent folder for the study within the GXP Collaborate environment under Shared > eTMF.
- Locate and click into the folder with a name that matches the study name. From the study folder, select More from the folder’s top navigation, and click Folder Details & Options.
- From the Details tab of the modal, expand the Metadata section to find the section that was created for study metadata.
Any metadata field values defined at this level will be applied to all documents for that study.
Configuring Custom Document Metadata
Custom metadata can be configured by navigating to Collaborate > Settings > Metadata Tags > Configuration.
- Click Add New Section and give the section a name that clearly indicates it will contain TMF Document Metadata.
- Be sure to leave the toggle next to Enable metadata inheritance for this metadata section disabled. Any number of Study-Level fields can be added, with changes saved upon completion.
Assigning Values to Document Metadata Fields
Once custom document metadata fields have been added as described in the section above, users with permission (Filing Level Uploader, Filing Level Manager, Study Manager, eTMF App Admin, or Administrator) can populate those values on a per-document basis by navigating to a document in the TMF Document Viewer and scrolling down to the Metadata section.
Viewing Study And Document Metadata
Custom metadata defined at both the Study and Document level can be viewed for each study document in the Metadata section of the Details tab of the TMF Document Viewer.
TMF Document Data can be modified on a per-document basis by users with permission directly via the TMF Document Viewer. TMF Study Data is defined on a per-study level by modifying the values at the parent folder level (see Assigning Values to Custom Study Metadata Fields section above).