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Mastering the basics of Good Clinical Practice

Mater Education, in partnership with Mater Research, is pleased to offer Mastering the basics of Good Clinical Practice (GCP).  This course has been developed to provide an opportunity for researchers to learn the history of the ICH-GCP, the importance of GCP and other regulatory guidelines when conducting clinical research.

Good Clinical Practice is the international ethical, scientific and quality standard for designing, conducting, recording and reporting trials that involve the participation of humans, to which all clinical researchers should comply. GCP compliance ensures that the rights, safety, and wellbeing of research participants are protected, and that research data is reliable.

Delivered via online modules as well as face-to-face lectures, the course covers the key aspects of the clinical research process while reviewing each section of the GCP guidelines. 

This course is available to Mater People only. 

Learning objectives

By the end of this course you will be able to:

  • describe the purpose and principles of ICH-GCP, including ICH, FDA directives and good documentation practice (GDP)
  • outline the significant milestones in the history of GCP development
  • define the standards for working with human subjects, including vulnerable populations
  • describe the roles and responsibilities of ethics committees (IRBs/IECs/HRECs), research governance (RGO) investigators, sponsors and monitors in the clinical research process
  • review implications of the Clinical Trial Regulation and following guidelines
  • differentiate between an adverse event, adverse drug reaction, and serious adverse event
  • list at least 10 of the required elements of informed consent
  • Identify essential documents, including the investigator's brochure and documents that require HREC, RGO review, and approval
  • describe the standard elements of a clinical trial protocol
  • define key terms used in clinical trials internationally, including Investigator, sponsor, monitor, essential documents, informed consent, adverse event and serious adverse event
  • discuss  practical applications of GCP through case studies discussed throughout the courses.

The following modules are incorporated within the GCP course:

  • overview of clinical trials in the Australian context
  • ethics
  • ICH-GCP guidelines
  • GCP test-out challenge.

Location

Corbett Room, Whitty building
Mater's South Brisbane campus

Dates

15 March 2017
7 June 2017
10 August 2017
1 November 2017

How to apply

Please register your interest for this course by completing the below expression of interest form, and a member of our team will be in touch with you shortly. 

Duration

8 hours. Mater People are required to obtain manager approval prior to attending this course.