Reference Documents

Competency Development Tool

To download the French version of ACRP Entry-level CRC Competency Development and Assessment Roadmap, complete the fields below:

If you have any questions about the French version of the Roadmap, please contact Sara Paré: spare@qcroc.ca

To download the original English version, click here.

ICH Harmonised Guidelines

Reference Documents from Health Canada

This guidance document from Health Canada will help anyone involved in conducting clinical drug trials on humans to understand and comply with Title 5 of Part C of the Food and Drug Regulations.

This policy presents to all stakeholders involved in the clinical trial process Health Canada national approach to compliance and enforcement, as well as the inspection strategy for clinical trials of drugs involving human subjects. It also briefly describes the inspection process used to assess whether the activities conducted by a regulated party comply with the Food and Drugs Act and Part C, Title 5 of the Food and Drug Regulations.

You will find here the main guidelines to help you comply with the applicable regulations in conducting clinical trials.

You will find here the main guidelines to support your clinical trial applications.

This guidance document from Health Canada describes how inspectors from the Clinical Trials Compliance Program classify their observations based on risk and explains the process of assigning an overall rating to an inspection.

Site Resource For Invoiceables

SCRS developed a resource to assist sites in their understanding of key components to protocol budgets. Understanding these components and ensuring sites consider them for each trial budget is essential to the financial foundation of the site to ensure sustainability throughout the lifecycle of each protocol they undertake.

Checklist : Talking to Your Patient About a Clinical Trial

Talking to a potential participant about enrolling in a clinical trial is not always easy. Fortunately, the National Institutes of Health (NIH) has put together an informed consent self-evaluation checklist to help you.