Clinical trial applications
In September 2001 Health Canada Food and Drug Regulations (Part C, Division 5) were amended to require sponsor submission of a clinical trial application (CTA) for drug trials, a reduced default time for Health Canada review of applications, sponsor compliance with Good Clinical Practices (GCP), and Health Canada inspections/compliance verifications. Please refer to their website at http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index_e.html.
Following receipt of a CTA by a study sponsor and Health Canada's internal review, either a 'No objection letter' or 'Not satisfactory notice' is issued by Health Canada. SickKids withholds REB approval pending receipt of a copy of the study's 'No objection letter'. While investigators are encouraged to initiate the CTA process early, please note that any protocol amendments resulting from REB review will need to be submitted to Health Canada for approval. Clinical trials involving medical devices require a similar but separate process.
A similar Health Canada review and approval process exists for clinical trials involving natural health products. Under the Natural Health Products Regulations, which came into effect on January 1, 2004, natural health products (NHPs) are defined as:
* Vitamins and minerals
* Herbal remedies
* Homeopathic medicines
* Traditional medicines such as traditional Chinese medicines
* Probiotics, and
* Other products like amino acids and essential fatty acids.
Submissions satisfying the NHP Directorate's requirements will be issued a Notice of Authorization to commence the trial. For further information, please refer to their website at http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/clini/index_e.html.
For assistance with interpreting the regulations, or assistance with preparing a clinical trial application, please contact Julie Gibson, Director of Clinical Research Services, at julie.gibson@sickkids.ca.
New guidance from Research Pharmacy concerning research studies involving drugs/biologics or Natural Health Products is now posted under "Guidelines, procedures & policies".
Updated guidance effective June 15, 2006 regarding the retention of records related to clinical trials can be found at the Health Canada website http://www.hc-sc.gc.ca/dhp-mps/compli-conform/index_e.html.