File-level management of essential documents

In the eTMF application, the Essential Documents page represents file storage based on the DIA TMF reference model. It contains specific files required for compliance and regulatory purposes. These files are used for planning and integrity purposes, for example, a file that includes the detailed plan of the eClinical trial, along with modifications made to the original protocol.

After you have analyzed the details of the files of interest via the Essential Documents storage, you can manage your essential documents at different levels that represent study containers, the folders inside the study containers, and the files inside these folders.

Your files stored in essential documents can be managed with the functionality discussed in the following sections.