Design and Conduct of Clinical Trials

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  • Bias Control: Randomization and Masking
    • Every trial design depends on the skilled application of core design elements. In this module, you’ll learn about various approaches to bias control as well as simple, restricted, and adaptive approaches to trial participant randomization. Finally, you’ll learn to protect the validity of your results with masking procedures that conceal treatments and outcomes as necessary from the study team, participants, and outcomes assessors.
  • Trial Stages and Designs
    • Each trial is conducted in stages, so it’s critical that you and your team are prepared to make sound design choices for each stage. That includes developing and evaluating research questions and hypotheses, selecting among various design types, and identifying errors.
  • Outcomes in Clinical Trials
    • Well-defined outcomes are the foundation of any good trial design. The outcomes that you and your team establish at the beginning of the design process will influence other design decisions such as trial type, randomization, masking, sample size, and more.
  • Ethical Issues in Clinical Trials: Informed Consent
    • Trials participants must be treated with the utmost respect, and that begins with careful attention to informed consent. In this module, you’ll learn about the personnel, documents, terminology, and practices that go into planning and implementing ethically sound informed consent procedures within your trial.
  • Recruitment and Retention
    • ​​A trial without participants is no trial at all. In this module, you’ll learn how to ethically and effectively recruit and retain the participants you need for your trial and strategically select the clinical sites where you’ll conduct your research.

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