Clinical Trials

Health Canada Regulated Clinical Trial Tools and Templates:

New Investigators conducting a Health Canada regulated Clinical Trial

Supports for Investigator-Sponsored Clinical Trials

Health Canada Regulated Clinical Trial Required Training:

Good Clinical Practice (GCP)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Health Canada requires this training for investigational drug trials phases I-IV, Natural Health Product studies and Investigational Medical Device studies.

Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects

Training in Part C, Division 5 of the Food and Drug Regulations is a Health Canada required expectation for investigational drug trials phases I-IV.

Two training options:

  1. Live (online) via Research Education Program Manager, contact to book a TransCelerate GCP session with Division 5
  2. Online on your own time: As a member of N2, Nova Scotia Health is pleased to announce the following CITI-Canada courses that are available:
  • ICH-GCP 
  • ICH-GCP Refresher
  • Health Canada Division 5 

When registering for a CITI account (, please ensure that you choose “Nova Scotia Health Authority” for your institution. 

Privacy and Research Supports

PHIA came into force on June 1, 2013. This legislation, similar to that in existence in other provinces, deals with the collection, use, disclosure, retention, disposal and destruction of personal health information.

PIIDPA came into effect in 2006. It protects privacy by restricting the disclosure of personal information outside Canada, as other countries may not have equivalent data protection laws. Personal information (including participants’ personal health information and researchers’ CVs) may only be stored or accessed outside Canada with the consent of the individual.

Institutional Accreditation Certificates (for Regulated Clinical Trials)

Health Canada Government Resources

SOP for Sponsors