Trusted Resource for Clinical Trials, Protocols & Progress
This SOP defines the process for submitting documents, obtaining approvals, and reporting to Research Ethics Boards (REBs) to ensure compliance with Division 5 and ICH-GCP requirements. It establishes timelines, documentation standards, and communication pathways to safeguard participant rights and maintain regulatory oversight throughout the clinical trial lifecycle.
Click to read the full article.
The purpose of this SOP is to establish clear, regulatory-compliant processes for the identification, assessment, documentation, and reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and Development Safety Update Reports (DSURs) to Health Canada. It ensures timely communication, protects subject safety, maintains sponsor obligations under Division 5 of the Food and Drug Regulations, and aligns with ICH-GCP and ICH E2A/E2F guidelines.
Click to read the full article.
This SOP defines the processes for preparing, translating, verifying, and controlling bilingual (English and French) documentation used in clinical trials. It ensures compliance with Health Canada Division 5, ICH-GCP, and REB requirements, guaranteeing that participants receive understandable and accurate information while sponsors maintain regulatory compliance and inspection readiness.
Click to read the full article.
The purpose of this SOP is to establish procedures for preparing, submitting, and managing Clinical Trial Applications (CTAs) and related lifecycle events in Canada under Division 5 of the Food and Drug Regulations. It provides guidance for sponsors, CROs, and investigators to ensure compliance with Health Canada requirements, safeguard subject safety, and maintain regulatory transparency. This SOP addresses initial CTA submission, amendments, notifications, withdrawal, and end-of-trial reporting.
Click to read the full article.
