The purpose of the certificate is to integrate currently available training, such as the ACRC recommended training courses, while providing additional content, patient-oriented research concepts, and practical application exercises using real-world and Alberta-specific examples.

Upon completion of the certificate, participants will be able to:

  1. Employ a common understanding of information required to work on clinical trials in Alberta
  2. Develop and apply knowledge of specific regulations, good clinical practice, research ethics standards, and trial management
  3. Apply knowledge of resources and structure of clinical trials processes in Alberta
  4. Identify and integrate patient-oriented research principles into practice

The certificate content has been informed and approved by an Advisory Committee of leading experts in clinical trials in Alberta. A map overview of the main content areas is shown below:

 

The content has been organized into a chronological sequence that reflects the progression of a clinical trial, from pre-trial activities to study conclusion:

  • Introduction to Certificate
  • Introduction to Patient-Oriented Research
  • Overview of Clinical Trials
  • Drug Development Process
  • Regulated Research
  • Ethics in Clinical Trials: History & Principles
  • Patient-Oriented Research in Clinical Trial Design
  • Integrated Knowledge Translation: Creating a Patient-Oriented KT Plan in Clinical Trial Design
  • Planning Recruitment
  • Planning Consent Procedures & Documentation
  • Ethics Applications, Privacy & HIA
  • Investigator Initiated Protocols vs. Industry Sponsored Protocols
  • Financial Management: Contracts & Insurance
  • Financial Management – Accounting, Planning and Preparing Trial Budgets
  • Overview of Good Clinical Practice
  • Obligations of the Sponsor, the PI, and Trial Staff
  • Regulatory Binder Delegation Log
  • Training, Product Accountability & Other Study Logs
  • Conducting Recruitment and Informed Consent Procedures
  • Data Collection Tools
  • Case Report Forms
  • Source Documents & Monitoring
  • Adverse Events
  • Protocol Deviations & Reporting Requirements
  • Maintaining Documentation
  • Audits
  • Final Reporting
  • Archiving
  • Closing Accounts
  • Dissemination: Publications, Presentations & Participants
  • Drawing Conclusions
  • Acknowledgement of Participants

 

External Content

A wealth of quality training is already available on various clinical trials topics. However, there has not been a single training opportunity that puts all of this content into the context of overall clinical trial conduct and provided supplementary material that incorporates practical application and patient-oriented research.

Pre-RequisitesIntegrated External content
The following courses are to be completed prior to the certificate start date. These pre-requisites will provide some base knowledge, terminology, and understanding of clinical trial conduct to ensure that all learners are equipped for the first sessions. Proof of completion must be provided to the Training Coordinator within one week of the Certificate start date.

TCPS-2: Course on Research Ethics

NIH: Protecting Human Research Participants

CITI-Canada: Good Clinical Practice

This content is included in the curriculum as it becomes relevant and in preparation for future module topics:

Alberta Health Services: Health Information Act Awareness – Week 2

Government of Alberta: Freedom of Information and Protection of Privacy – Week 2

CITI-Canada: Health Canada Division 5 – Week 4

CITI-Canada: Clinical Research Coordinator Certification – Week 8