Free, online training available to University of Waterloo researchers.
 

  • CITI (Canadian courses)
  • CITI (US courses)

CITI Canada

Contact: researchethics@uwaterloo.ca

Course name Requirement How to access Description
Responsible Conduct of Research

Highly recommended for all University of Waterloo faculty, staff or students engaged in research

Principal Investigator’s may wish to have their team members complete the course

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  • Suitable for inclusion into research methods course
  • Suitable for inclusion into orientation and on boarding activities
  • Particularly useful for honours thesis students and graduate students
  • Includes real life scenarios, videos, case studies
  • Deals with common issues which could give rise to charges of research misconduct
  • Includes unit tests

Modules include:
1. Ethics and the Responsible Researcher
2. Research Misconduct
3. Data Acquisition and Management
4. Publication Practices and Responsible Authorship
5. Peer Review: Role and Process in Life Sciences Research
6. Responsible Mentoring
7. Collaborative Research
8. Conflicts of Interest in Research
9. Human Participants Research and Ethics

Good Clinical Practice Required by many research sponsors and collaborators such as hospitals, other universities, pharmaceutical companies

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  • Particularly useful for faculty, students involved with clinical research such optometry and pharmacy
  • Includes unit tests

Modules Include:
1. Overview of new drug development
2. International Conference on Harmonisation (ICH): Good Clinical Practice (GCP) Requirements
3. Health Canada and US FDA Regulated Research
4. Conducting Investigator-Initiated Studies According to Health Canada and FDA Regulations and Good Clinical Practices
5. Investigator Obligations in Health Canada and FDA-Regulated Clinical Research
6. Managing Investigational Agents According to GCP Requirements
7. Conducting Clinical Trials of Medical Devices
8. Informed Consent
9. Detection and Evaluation of Adverse Events
10. Reporting Serious Adverse Events
11. Monitoring of Clinical Trials by Industry Sponsors
12. Audits and Inspections in Clinical Trials

  • Meets TransCelerate’s criteria for ICH GCP training
  • TransCelerate represents many of the largest biopharmaceutical companies and if you are working with an affiliated company, you can ensure them that your CITI-Canada training has formal approval and recognition from TransCelerate by completing this course
Biomedical Research Ethics  

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  • Particularly useful for faculty, students and staff involved with biomedical research such as Applied Health Science, parts of psychology, biobanks, genetic repositories, medical device development
  • Includes unit tests

Modules include:
1. Introducing Biomedical Research Ethics
2. Guidelines and regulations
3. Research Ethics Boards and Ethics review process
4. Harms and benefits
5. The process of free and informed consent
6. Privacy and confidentiality
7. Conflict of interest
8. Special research design issues

Health Canada Division 5 - Drugs For Clinical Trials Involving Humans

Required by many research sponsors and collaborators such as hospitals, other universities, pharmaceutical companies

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  • Particularly useful for faculty, students involved with clinical research such optometry and pharmacy
  • Includes unit tests
  • Successful completion of this course can be used as evidence of training in Division 5 Regulations
  • This course covers all research conducted under Division 5 Regulations and it provides practical solutions and methods for complying with the Regulations
Transportation of Dangerous Goods  

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  • Complements required training available from the University of Waterloo Safety Office
  • Includes unit tests

Modules Include:
1. Introduction to Transportation of Dangerous Goods (TDG)
2. Classification of Dangerous Goods
3. Packaging and Containment Systems
4. Marking and Labelling
5. Documentation
6. Emergency Response Assistance Plan (Erap) and Accidental Release Reporting

Social and Behavioural Research  

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CITI United States

Contact: researchethics@uwaterloo.ca

Course name Requirement How to access Description
Conflicts of Interest (COI)

Satisfies the training requirements associated with the U.S. Public Health Service (PHS) regulations on financial conflicts of interest

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  • Provides an overview of the U.S. PHS regulations on financial conflicts of interest.                                                                
  • Includes discussion of an investigator’s responsibilities relating to the disclosure of “Significant Financial Interests” and institutions roles in reviewing and evaluating.                                                           
  • Discusses non-financial COIs and strategies to address     

Modules include:

1. Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules

2. Institutional Responsibilities as They Affect Investigators

3. Conflicts of Commitment and Conscience

4. Institutional Conflicts of Interest

               

Good Clinical Practices Satisfies NIH training requirement in GCP

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  • Courses are available with a focus on

1.  Clinical Trials Investigational Drugs and Medical Devices (U.S. FDA Focus)
2.  Clinical Trials with Investigational Drugs and Biologics (ICH Focus)
3.  Clinical Investigations of Devices
4. Social and Behavioral Research Best Practices for Clinical Research

  • Recommended for research personnel involved in drug, biologic, or device studies and who would benefit from FDA-focused training
  • Particularly useful for individuals wanting to learn about clinical research regulations in the US
     
Human Subjects Research (HSR)   CITI Program sign in page
  • Courses are available with a focus on

1. Biomedical (Biomed) Basic
2. Social-Behavioral-Educational (SBE) Basic
 

  • Courses are updated to reflect the 2018 Requirements of the Common Rule.
  • Particularly useful for faculty, students and staff that want to learn about American regulatory and ethical standards.
Information Privacy & Security (IPS) Required by many research sponsors and collaborators such as hospitals, other universities, pharmaceutical companies CITI Program sign in page
  • Courses are available with a focus on

1. Family Educational Rights and Privacy Act (FERPA)

2.  Health Privacy (HIPAA)

3.  Information Security

  • Particularly useful for faculty, students and staff that want to learn about HIPPA and compliance, quality assurance, and risk reduction that will help ensure compliance with the US privacy acts.
Good Laboratory Practice  

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This course is intended for anyone involved or planning to be involved in nonclinical laboratory studies within industry, academia, government, or other testing facilities. It provides a working knowledge of GLP.

Topics covered include:

  • FDA, EPA, and USDA regulations, and OECD international guidelines pertaining to GLP
  • GLP definitions,
  • SOPs and equipment operation
  • study protocols
  • archiving study data and specimens,
  • quality assurance

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