Regulatory Affairs - Global Regulatory Harmonization for drugs & medical devices- IMDRF and ICMRA. Peivand Pirouzi, Ph.D.

In this video, Professor Peivand Pirouzi provides a step-by-step guide on how to complete the Clinical Trial Site Information Form as part of the Clinical Trial Application (CTA) process to Health Canada, submitted in the Common Technical Document (CTD) format. This form is essential for providing detailed information about the clinical trial sites involved in the study, including the qualifications of the investigators and the capabilities of the facilities.

Key topics covered include:

An overview of the purpose and importance of the Clinical Trial Site Information Form in the CTA submission.
Detailed instructions on how to complete each section of the form, including site identification, investigator information, and site-specific requirements.
How to ensure the form complies with Health Canada regulations and expectations.
Tips for including accurate and complete site information to avoid delays in the review and approval process.
Common challenges when completing the form and how to overcome them effectively.

This video is invaluable for clinical trial managers, sponsors, and regulatory affairs professionals involved in submitting a CTA to Health Canada. By following Professor Pirouzi’s guidance, you will ensure the Clinical Trial Site Information Form is completed correctly, supporting the successful approval of your clinical trial application.