Change Process Flowchart

This diagram illustrates how changes during clinical trials should be managed. The process includes the following steps:

1. Determining the Type of Change: Types such as major changes, amendments, and notifications are identified.

2. Preparation of the Application File: Necessary documents and forms are prepared, and justifications for the changes are written.

3. Submission of the Application: The application is submitted via the Electronic Submission and Process Management System (EBS-ESYS), required documents are uploaded, and the application fee is paid.

4. Institutional Evaluation: The application is evaluated within 22 business days (timelines may vary in exceptional cases).

5. Decision Stage: Decisions may include approval/information, rejection, suspension, cancellation, or requests for additional information.