Good Clinical Practices

The Regulatory Operations and Enforcement Branch (ROEB) has the responsibility for the inspections and investigations of clinical trials.

These new functions were announced in January 2000, and along with the publication in June of the new Regulations on clinical trials involving humans, these provide a clear framework for the performance of clinical trials in Canada. In addition, these Regulations integrate the principles of Good Clinical Practices (GCP) as described by the International Conference on Harmonization (ICH).

The inspection of clinical trials will be initiated in close collaboration with the Therapeutic Products Directorate (TPD) and the  Biologic and Radiopharmaceutical Drugs Directorate (BRDD). Approximately 2% of all clinical trials will be inspected, a percentage similar to what is being performed in other jurisdictions. Results of these inspections may be used in the evaluation of submissions.

These inspection and investigation functions have as main objective to reduce risks to subjects enrolled in clinical trials, while encouraging sponsors in their research activities for new therapies.

COVID-19

• Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
• Vaccines and treatments for COVID-19

Consultations

• Consultation on the Risk classification guide of observations related to clinical trial inspections of human drugs (GUI-0043)
• Consultation on “Drugs for Clinical Trials Involving Human Subjects” (GUI-0100: Guidance Document – Part C, Division 5 of the Food and Drug Regulations)

Guidance Documents

• Guidance Document: Part C, Division 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects" (GUI-0100)
• Classification of observations made in the conduct of inspections of clinical trials (GUIDE-0043)
• Guidance Document - Annex 13 to the Current Edition of the Good Manufacturing Practices Guidelines Drugs Used in Clinical Trials (GUI-0036)
• POL-0030: Compliance and enforcement approach and inspection strategy for clinical trials of drugs involving human subjects

Regulations

• Regulations Amending the Food and Drug Regulations (1024 - Clinical Trials)

Reports

• Summary Report of Inspections of Clinical Trials Conducted from April 2004 to March 2011 [2012-03-28]
• Summary Report of the Inspections of Clinical Trials Conducted Under Voluntary Phase
• Summary Report of the Inspections of Clinical Trials Conducted in 2003 / 2004

Related resources

• International Conference on Harmonization GCP - ICH E6