General Improvements

TI SSU enforces all essential documents to be reviewed as a part of a two-step workflow, i.e., by a Study Start-up Specialist and Regulatory Reviewer.

Automatic Submission for Second-Step Approval

The Study Start-up Specialist will no longer be required to submit documents to the Regulatory Reviewer for approval. The system would automatically push these documents for second-step approval and notify the Start-Up Specialist.

TI SSU supports communication with Sites through Regulatory Packages and Emails linking documents. Additionally, the system supports maintaining communication logs and setting up the next Contact date.