Good Clinical Practice (GCP) Refresher

Good Clinical Practice (GCP) Refresher

This is an abbreviated course for participants who have already undertaken full GCP training.

About This Course

GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving humans’ participation.

Compliance with the GCP standard provides Public assurance that the rights, safety and well-being of trial participants are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

The Good Clinical Practice (GCP) Refresher online training course is specifically designed to assist clinical researchers who have already undertaken a previous GCP Course to refresh their knowledge of the basic principles of GCP and how these principles can be applied in the research setting.

The GCP Refresher course includes new and revised content relating to current regulations and guidelines for Australian clinical trials.

Although ICH GCP primarily relates to clinical trials, all human research conducted in Australia should be undertaken in accordance with the GCP principles contained in the National Statement and ICH GCP (where relevant).

Researchers are encouraged to refresh their training in line with jurisdictional requirements (e.g. every 2-3 years).

This course has been approved by the TransCelerate Site Qualification and Training Initiative, which is a Mutual Recognition Program for ICH E6 GCP Training, targeted at investigator site personnel. With the ability to exit and resume the course at any point, participants will have the flexibility to fit the course into their busy schedules and gain valuable insights into this critical aspect of clinical trials.

For those who have not undertaken previous GCP training, the RETProgram GCP in Australia course can be found HERE.

course duration
This course will approximately take 90 minutes to complete!

Pricing

WAHTN-Partners

Free

WAHTN Partners have free access to this course
AHRA Partners

$40

Participants from the AHRA partner organisations have discounted access to this course.
Public Access

$80

Any person from the public can gain access to the course.

Course Objectives

  • Understand GCP Principles and Guidelines

  • GCP Roles and Investigator Responsibilities

  • Qualifications, Resources, Agreements

  • Communication with HREC

  • Informed Consent of Participants

  • Records and Reports

  • Progress and Safety Reporting

  • Premature Termination and Final Reports

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