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    • Describe how clinical trials are approved and regulated in Canada.

    • Understand the general standards for Good Clinical Practice (GCP).

    • Summarize the requirements and process for obtaining informed consent /assent.

    • Apply the privacy and confidentiality requirements in clinical trials.

    • Understand how barriers to access by underrepresented groups and related inclusion strategies impact clinical trials.

    • Describe reporting requirements related to adverse events during and after clinical trials.

  • Module 1. Introduction to Clinical Trials and Regulations

    Part 1. Introduction to clinical trials 

    Part 2. Brief history of clinical trials 

    Part 3. International regulations and milestones 

    Module 2. Regulations, Roles, and Ethics

    Part 1. Regulatory framework in Canada 

    Part 2. Role and responsibilities 

    Part 3. Ethics, privacy, and informed consent 

    Module 3.  Equity and Safety Considerations 

    Part 1. Health equity in clinical trials  

    Part 2. Considerations for children and pregnant people 

    Part 3. Safety reporting and adverse events 

    Course Assessment

  • This course was developed by scientific and regulatory experts and reviewed by a patient engagement and EDI specialist. Acknowledgments: Lauren Kelly, Nancy Butcher, Rebecca Barnes, Deborah Leal, Isabelle Malhamé, Ashley Hayward, Tamorah Lewis, Natalie Rodriguez, Dawn Richards, Chelsea Bowkett, Mansi Tiwari, Zina Zaslawski, & Matthew Prebeg.

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    • Explain the rationale and importance of engaging patients and families in pediatric and perinatal clinical trials

    • Understand and describe how researchers, patients, and family partners can collaborate throughout a trial

    • Identify the barriers and facilitators of patient and family engagement

    • Find and utilize resources for meaningful partnerships in trials

  • Module 1: The How, When, and Why of Patient and Family Engagement in Clinical Trials

    Module 2: Engaging Parents and Pregnant People in Clinical Trials

    Module 3: Engaging with Children and Youth in Clinical Trials

    Module 4: Practical Considerations and Resources for Patient and Family Engagement

    Course Assessment

  • This course was developed by scientific and regulatory experts and reviewed by a patient engagement and EDI specialist. Acknowledgments: Sara Pot, Nancy Butcher, Andrea Cross, Samantha Micsinszki, Maureen Smith, Melila Chesick-Gordia, Lauren Kelly, Natalie Rodriguez, Dawn Richards, and Chelsea Bowkett.

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    • Apply best practices to develop robust and ethically sound trial designs tailored to pediatric and perinatal populations.

    • Identify key methodological elements and considerations that inform high-quality and high-impact trial design.

    • Evaluate various trial design types, including adaptive and non-adaptive approaches, and assess their advantages, limitations, and applications to answering pediatric and perinatal research questions.

  • Module 1: Clinical Trial Design

    Part 1. Study Protocols, Research Questions, and Study Populations

    Part 2. Interventions and Comparators

    Part 3. Trial Outcomes

    Module 2: Trial Design Features

    Part 1. Trial Design Features

    Part 2. Trial Operating Characteristics

    Module 3: Non-Adaptive Trials

    Part 1. Conventional or Non-Adaptive Trials

    Part 2. Adaptive Trials, Master Protocols, and Platform Trials

    Part 3. Other Trial Designs

    Course Assessment

  • This course was developed by scientific and regulatory experts and reviewed by a patient engagement and EDI specialist. Acknowledgments: Lauren Kelly, Nancy Butcher, Beth Potter, Anna Heath, Srinivas Murthy, Natalie Rodriguez, Dawn Richards, Chelsea Bowkett, Zina Zaslawski, & Matthew Prebeg.

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    • Summarize key principles and applications of knowledge mobilization in pediatric and perinatal clinical trials.

    • Describe various types of knowledge mobilization activities, strategies, and resources

    • Recognize effective communication strategies for discussing pediatric and perinatal trials with diverse audiences

    • Describe ways to use inclusive language and visuals to support effective communications

    • Summarize good practices and resources for trial publications

  • Module 1: Knowledge mobilization for pediatric and perinatal clinical trials

    Part 1. Knowledge mobilization 101

    Part 2. Sharing our message: tips for reaching patients and the public

    Part 3. Examples and resources

    Module 2: Communicating effectively and inclusively in clinical trials

    Part 1. Conversations that count: Talking about pediatric and perinatal trials

    Part 2. Inclusive language and visuals

    Part 3. Social media and media messaging 

    Module 3: Academic writing and good publication practices for clinical trials

    Part 1. Introduction to trial writing

    Part 2. Tools to support writing and peer review

    Part 3. Authorship

    Course Assessment

  • This course was developed by scientific and regulatory experts and reviewed by a patient engagement and EDI specialist. Acknowledgments: Nancy Butcher, Lauren Kelly, Lisa Knisley, Maureen Smith, Michelle Wan, Zina Zaslawski, Natalie Rodriguez, Israa Sinan, Dawn Richards, and Chelsea Bowkett.

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