Description
The Clinical Trial Site Information (CTSI) form is required to be submitted by clinical trial sponsors prior to initiating a protocol or implementing subsequent amendment(s) at the clinical trial site for trials that are subject to Division 5 of Part C of the Food and Drug Regulations or the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.
Resources
| Name | Format | Description | Link |
|---|---|---|---|
| Instructions for completing the Clinical Trial Site Information Form | HTML | Open resource | |
| Instructions for completing the Clinical Trial Site Information Form | HTML | Open resource |