Harmonisation of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) and ICH-Good Clinical Practice

As early as 1996, concern was raised that there may be important differences in the early drafts of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) 1
and Canadian and international regulatory requirements, particularly the International onference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance E6: Good Clinical Practice: Consolidated Guideline (ICH-GCP) 2
adopted by Health Canada. It was thought that these documents were not fully aligned with each other, and thus researchers and REBs might not be compliant with Health Canada regulations if they adhered solely to the TCPS.