ACRC: Training Recommendations for Clinical Health Research
High quality research stems from training and a knowledgeable research team.”Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” [ICH GCP E6 (2.8)]”.
It is with this principle in mind that on March 20, 2015 the ACRC, speaking as representatives of the partner organizations endorsed a series of training recommendations. Please refer to your organizational and institutional guidelines for additional training requirements.
Training Recommended for Clinical Health Research (assessing drug, medical device or natural health product)
Individuals involved in clinical (health) research are encouraged to take the attached recommended courses to expand their knowledge of best practices, applicable guidelines and legislation. Courses endorsed by the ACRC are free to members of the ACRC partner organizations.
This self-paced course is a media-rich learning experience that features interactive exercises and multidisciplinary examples. CORE consists of eight modules ranging from Core Principles to REB Review. It is designed primarily for the use of researchers and REB members – though anyone may take this course and print their own certificate of completion.
How should you conduct your research? What practices should you follow? Researchers are expected to act with integrity by the public, their colleagues, their institutions, and funding sources. The Responsible Conduct of Research (RCR) course provides the learner with a solid foundation of knowledge relating to the norms, principles, and rules governing responsible research practices.
Who should take this course? The course is suitable for researchers, students and other personnel from all clinical health research disciplines and fields.
Health Information Act – when research involves the collection, use and disclosure of health information.
Freedom of Information Protection (FOIP) Act – when research involves the collection, use and disclosure of personal information.
This course is available to public bodies (i.e. post- secondary institutions, health care bodies) and covers:
- Collection, use and disclosure of personal information under FOIP
- Protecting personal information
- How the public may access information
- Offences and penalties under FOIP
- Formal and informal complaint and oversight mechanisms.
AHS Information Privacy and IT Security Awareness – when the study involves access to either health or personal information held by AHS and Covenant Health.
In order to gain access to the AHS network, affiliates of AHS must complete mandatory information privacy and IT security awareness.
Good Clinical Practice (CITI Canada)
This 13-module course outlines good clinical practice as it relates to clinical trials of drugs, biologics and medical devices. The discussion is focused on the following Canadian and American regulations:
- Health Canada-Division 5,
- Tri-Council Policy Statement 2 (TCPS2),
- Food and Drug Administration (U.S. FDA) and,
- International Conference on Harmonisation (ICH)-E6.
Who should take this course? The course is suitable for individuals conducting clinical trials on drugs and devices in Canada. Several pharmaceutical companies accept CITI-Canada’s GCP completion certificate as equivalent to GCP training conducted by the company. This has reduced duplication and cost for both investigative sites and sponsors.
The Canadian Food and Drugs Act and the Food and Drug Regulations govern the sale and importation of drugs for use in human clinical trials in Canada. Specifically, Part C, Division 5 of the Regulations address drugs for clinical trials involving human participants. The Principle Investigator is ultimately responsible for ensuring compliance of all members of the study team with the Regulations and the International Conference on Harmonization – Good Clinical Practice (ICH-GCP E6) guideline. To that end, there should be evidence of satisfactory training of personnel involved in these processes. The successful completion of this CITI-Canada course can be used as evidence of training on Division 5 of the Regulations. The course covers all research conducted under Division 5 and provides practical solutions and methods for compliance.
National Institute of Health (NIH) – Protecting Human Research Participants – Required only for NIH, NCIC-CTG and cooperative group studies, optional for other funders.
A free online training from the National Institute of Health in the United States on human subjects protection.
Training Recommended for Clinical Health Research (Not assessing a drug, device or natural health product)
Training for clinical health research which does not involve an investigational product would still carry the recommendation of completing TCPS2, CITI-RCR, CITI-GCP, HIA, FOIP institutional privacy and NIH training. Health Canada Division 5 is optional for a study that does not involve drug or natural health product.
Training Recommended for Health Services Research (Quality Improvement, Evaluation)
Health Information Act – when research involves the collection, use and disclosure of health information
ARECCI has training courses and ethics decision support tools and training to assist in integration of appropriate ethics considerations in projects to protect participants, whether the project is evaluation, quality improvement, quality assurance, or research.