New Report: CRA Reconciliation

With TI v10.5, a new report shows Visit Status, Reconcile Date, Reconciled By, and Submitted On across multiple sites simultaneously.

The report lists all the documents by these statuses:

  • Missing in eTMF
  • Missing in ISF
  • Verified
  • Null (if haven't checked by CRA yet)
  • Blank status (not verified during the visit)

New Report: Documents for Completed Events

Documents status on Completed Events Report

With TI v10.5, a new report is available that lists the status of the documents for the completed events. This report provides a more robust picture as the users can now monitor the collection of documents for completed events. The report includes both placeholders and already-filed documents.

New Report: Document Timeliness

Calculate the time from Submission to Finalization.

CROs and Sponsors need to strictly monitor the cycle time for processing documents. It becomes important to identify the time to submit the document to the eTMF and then from submission to finalization.

Currently, this is supported through KPI dashboards. With TI v10.5, the system has a new report for providing details of every document submitted in the system with the cycle times for each step.

New Report: Document Timeliness

Calculate time from Query Generation → Response → Resolution

All document queries must be addressed/resolved within the designated SLA, as any delay has an impact on the Queries. With TI v10.5, a new report is available to help CROs and Sponsors track the time taken from:

  • Query Generation to Query Response
  • Query Response to Query Resolution

This report allows users to identify blockers and mitigate them.

New Report: Consolidated Completeness Report

Consolidated Completeness Report for all categories

Until now, the system provided three separate reports for document completeness for Site, Trial, and Country categories.

TI 10.5 introduces a new report that provides a consolidated completeness view for all three categories of documents. The report also provides a summary of the documents for the three categories.