Introduction to Good Clinical Practice - E6 R(2)

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Introduction to Good Clinical Practice in Clinical Research (ICH-GCP E6 R(2)) for clinicians working in the AOD sector

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Length: 4 hours

Workshop Goal: To give participants involved in research and trials a thorough understanding of all aspects of Good Clinical Practice and how it applies to everyday trial management .

Description: The workshop contains five sessions of guidance, education, activities and interactive learning that cover all components of Good Clinical Practice relevant to staff working on research and clinical trials that involve humans . The course will be specifically focused on clinical research within the Alcohol and other Drug sector.

Learning Outcomes:

At the end of this workshop you should be able to:

  • Demonstrate an understanding of the importance of the interwoven laws, frameworks and guidelines which govern the set up and conduct of clinical research
  • Demonstrate an understanding of the roles and responsibilities of different individuals and organisations in clinical research
  • Understand the regulatory applications required before clinical research can be started in Australia
  • Identify a range of essential documents and the purpose of maintaining a trial master file
  • Understand the process of receiving informed consent (and equivalent processes where appropriate) and the roles and responsibilities of those involved in this process
  • Demonstrate the ability to correctly and accurately complete case report forms and other relevant documentation and understand the process for data query resolution
  • Demonstrate an awareness of the correct reporting requirements that ensure patient safety
  • Know where to go for further advice and support and how to keep updated.

Participants who complete the post-training quiz with a score of 80% or above will be awarded Transcelerate-accredited Good Clinical Practice (GCP) certification, valid for 3 years.

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Organiser NCCRED

Organiser of Introduction to Good Clinical Practice - E6 R(2)

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