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Transcript

Learning Objectives

During this module we'll outline the key concepts you need to understand before starting the simulation. We'll also cover the goals you should aim to achieve, ensuring you're well-prepared for the tasks ahead. By following these learning objectives, you will gain a deeper understanding of the clinical trial design process, develop the ability to critically evaluate clinical data, and enhance your skills in creating well-structured and guideline-compliant clinical trial protocols.

Remembering

Understanding

Applying

Analysing

Evaluating

Creating

  • Choose a hypothetical clinical condition and conduct a literature review to gather relevant data and guidelines for the trial design.
  • Use spreadsheet software to organise the gathered data and outline the trial protocol components.

  • Explain the significance of each component in a clinical trial protocol and how they contribute to the overall study design.
  • Describe the role of a clinical research practitioner in ensuring that a clinical trial adheres to ethical and methodological standards.

  • Analyse the gathered information to identify key elements that must be included in the clinical trial protocol.
  • Critically evaluate the relevance and applicability of the guidelines and literature to the chosen clinical condition.

  • Develop a detailed clinical trial protocol that includes all necessary components, ensuring adherence to relevant guidelines.
  • Create a presentation summarising the trial protocol and its key elements, designed for feedback and critique.

  • Identify the key components and steps in designing a clinical trial protocol (e.g., hypothesis formulation, methodology selection, inclusion/exclusion criteria, data analysis plan).
  • List relevant clinical guidelines and literature that inform clinical trial design.

  • Assess the coherence and comprehensiveness of the designed clinical trial protocol.
  • Evaluate the protocol against established clinical guidelines and best practices to ensure its scientific and ethical rigour.