Sponsor Requirements

Confidentiality Agreement or Non-Disclosure Agreement (CDA/NDA)

You must send a CDA/NDA to the Research Contract Specialist at Mount Sinai Hospital for review and approval prior to disclosing confidential information to the investigator(s). If you do not have such an agreement drafted, our office will gladly send you one of our templates for your review. Please note that both Mount Sinai Hospital and the Investigator will be parties to the CDA/NDA.

Paperwork

- Once the CDA/NDA is in place you can send all the information pertaining to the proposed
study to the investigator for review.
- As the Sponsor, you are responsible for the development of the Protocol and for monitoring the study, as well as other obligations which will be clearly written in the Clinical Trial Agreement.
- The investigator will prepare the necessary documents for submission to the Institutional Research Ethics Board.  For more information on the type of documentation that is required, please contact the Sinai Health System (REB).
- As the Sponsor, you are responsible for obtaining all regulatory approvals for the conduct of the study in Canada.

Clinical Trial Agreement (CTA)

Once the investigator has had an opportunity to review the materials provided and has agreed to participate in the Study, you can send an electronic version of the CTA to the Research Contracts Specialist, or in the alternative, to the Investigator who will then forward it to our office.

For further information, please contact arp_help@lunenfeld.ca for assistance.