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CLINICAL RESEARCH ASSOCIATIONS &

TRAINING RESOURCES

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SOCRA is an organization that provides education and certification for any individuals working in clinical research. Certification with SOCRA designates you as a Certified Clinical Research Professional (CCRP) which is recognized by the international clinical research community as evidence of your experience and knowledge in research regulations, ethics and the International Conference for Harmonization Guideline for Good Clinical Practice E6(R2) (ICH-GCP).

 

Certification requires a successful application as well as a written examination which evaluates your knowledge in ICH-GCP, ICH Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A, the United States Code of Federal Regulations (CFR) and ethical principles of research involving human subjects (The Nuremberg Code, the Belmont Report, and the Declaration of Helsinki). 

 

In order to maintain your accreditation, you must complete a minimum of 45 hours (45 credits) of Continuing Education every 3 years.  This ensures that research professionals are staying current with research trends and any new developments in the applicable regulations or guidelines.

 

SOCRA provides a variety of educational opportunities to its members, and non-members a like (although non-members will pay a higher fee for these activities). These include Live Conferences and Workshops, Online Training Programs as well as Live Webinars

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ACRP provides a variety of different credentials, specific to the role of the individual seeking certification. These include: Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), Certified Principal Investigator (CPI), ACRP Certified Professional (ACRP-CP), ACRP Medical Device Professional Subspecialty (ACRP-MDP), and ACRP Project Manager Subspecialty (ACRP-PM)

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The goal of each of these certification programs is to promote a gold standard in clinical research, and ensure that all applicable regulations, guidelines and ethical policies are being met.

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ACRP has an entire course catalog of training opportunities available to both members and non-members, for a fee. These courses range from entry level to senior, and are provided in a variety of formats. 

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N2 is a Canadian not-for-profit organization made up of research centers across the country. Currently there are 154 member organizations representing over 200 clinical research sites across Canada. These include institutions, universities, government, and private sector groups. Membership is typically not done on an individual basis.

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If you belong to a member organization, you will have access to:

  • The Collaborative Institutional Training Initiative (CITI) Training Courses - Learn more about CITI below

  • Member Resources including:

    • N2 SOPs: a complete set of template Standard Operating Procedures which meet both Health Canada and ICH-GCP requirements

    • Permission to Contact (PTC) Toolkit: use of the toolkit reduces consenting barriers by allowing patients to indicate whether or not they give permission to be contacted for future research opportunities as part of routine health clinic practice. 

    • Clinical Trial Education and Awareness Toolkits & Resources

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CITI provides educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and more. 

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CITI can be joined by organizations or on an individual level. There are over 157 courses available, including:

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  • Responsible Conduct of Research

  • GCP for investigations of Drugs and Biologics (ICH)

  • Conflicts of Interest

  • Essentials of Public Health Research

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If you are affiliated with an N2 member organization, you will have free access to certain CITI training courses. 

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NIDA provides a free of charge ICH-GCP training course, available to any interested parties.

The course includes 12 modules based on ICH-GCP guidelines and the Code of Federal Regulations (CFR).

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This is an excellent resource for anyone who does not have access to, or the means to pay for, the training programs outlined above. 

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Access a free of charge training program on Canada's Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2018)

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NACTRC Training
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NACTRC began as a collaboration between the University of Alberta and Alberta Health Services (AHS). Their goal is to provide streamlined services for clinical trials within the University of Alberta and AHS Edmonson Zone. They also provide researcher services to investigators outside of this framework on a fee-for-service basis. 

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NACTRC provides the following training and education opportunities:

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The QMCR unit at the University of Alberta ensures that clinical research is conducted to the highest scientific and ethical standards. The following courses are offered, however, some are only made available to those affiliated with the University of Alberta:

  • Investigator/Coordinator Clinical Research Orientation

  • Health Information Act Training Course (Free)

  • CITI Training: ICH-GCP E6 (R2)

  • ACRP Ethics and Human Subject Protection

  • CITI Training: Health Canada Division 5 

  • CITI Training: Clinical Research Coordinator (CRC) and Biosafety/Biosecurity (BSS) training

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Learn more about the availability of these courses here

ADDITIONAL TRAINING RESOURCES IN ALBERTA

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