Exceptional Circumstance Determination Application Process Flow Chart

This document summarizes the "Exceptional Case Detection Application Process Flowchart." The process is as follows:

1. Exceptional Case Detection Application: An application is made to determine whether the research qualifies as an exceptional case. Required documents are uploaded to the Electronic Submission and Process Management System (EBS-ESYS).

2. Institutional Evaluation: The application is evaluated by the institution within 3 business days.

3. Request for Additional Information and Documents: If necessary, additional information and documents are requested, and this stage also takes 3 business days. Following this, the institution re-evaluates the application.

4. Outcome: If the application is approved, an "Exceptional Case Clinical Research Application" can be submitted. If not approved, the process ends.

This flowchart outlines the step-by-step procedure for making and evaluating clinical research applications for exceptional cases.