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Study details

The Study Details module of TMF is designed to store the data on specific aspects of clinical trial management. Here, you can view and download various data as follows.

  • Table of Content: a complete report on all the study files stored in the eTMF system.

  • Query Details: a complete report on all the queries opened and managed in the eTMF system.

  • Expired File: a complete report on all the expired study files in the eTMF system.

  • Placeholders Tracking: a complete report on all placeholders in the eTMF system.

  • Audit Trail: a complete report on approval and rejections of files in the eTMF system.

  • Final Files Without Approval: a complete report on all files with final status that are not approved by dedicated personnel.

In this section:

In eClinical, queries are created to ask a question or get feedback from a designated system user on a particular data item. There are two types of queries in the system:

  • Manual query: these are created by the system users and assigned to responsible users to address the issues and either correct them or confirm the data's accuracy.

  • System query: these are generated automatically by the system and require user interaction to manage and resolve them.