Notice: Update to Clinical Trial Site Information Form

November 29, 2019

Our file number: 19-121907-606

In an effort to improve efficiencies, and to support the submission of Clinical Trial Applications (CTAs) using the electronic Common Technical Document (eCTD) format, Health Canada has updated the Clinical Trial Site Information (CTSI) form.

The changes to the form are summarized as follows:

In accordance with section C.05.006 (1)(d) of the Food and Drug Regulations, completed CTSI forms must be provided to Health Canada prior to commencement of the trial.

The new Clinical Trial Site Information form may be used immediately, however, it must be used as of January 2, 2020. The old form will not be accepted as of that date. Information on how to complete and submit the form to Health Canada is outlined in the instructions.

For questions related to Pharmaceutical CTSI forms, please contact hc.oct.enquiries-requetes.bec.sc@canada.ca

For questions related to Biologic CTSI forms, please contact hc.bgtd.ora.sc@canada.ca

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