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Good Clinical Practice training

All Principal Investigators of clinical trials with current HREC approval, or will gain HREC approval after 1 January 2020, will be required to provide evidence of current Good Clinical Practice (GCP) training to the Research Office.

We encourage all clinical research staff to attend GCP training.

The Eye and Ear will be requiring research team members to undertake Good Clinical Practice Training according to the following timeframes

Role date to provide GCP training certificate by 
Principal Investigators of Clinical Trials by 1 January 2020
Associate Investigators of Clinical Trials by 1 January 2021
All investigators involved in clinical research by 1 January 2022

 


When you have successfully completed or renewed a GCP TransCelerate approved training course (this will be included on the training certificate), please send a copy to the Research Office at ethics@eyeandear.org.au.

If you have any questions relating to GCP training, please email the Research Office.


The training must be delivered by a TransCelerate accredited provider and is valid for three years.

TransCelerate training is universally accepted and covers all the principles of GCP.

If you need to attend a course, please visit the TransCelerate website for approved courses.


 

Detailed information

In Australia, the following regulations apply

National Statement

1.1    Research that has merit is:

(e) conducted or supervised by persons or teams with experience, qualifications and competence that are appropriate for the research; and

5.2.6 For relevant health research, researchers should show that the research meets the requirements of the CPMP/ICH Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95), ISO 14155 Clinical Investigation of Medical Devices, the World Health Organization International Clinical Trials Registry Platform and the TGA.

 

Good Clinical Practice Guidelines

Good Clinical Practice states

3.1.3 The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation the IRB/IEC requests.

4. INVESTIGATOR

4.1 Investigator's Qualifications and Agreements

4.1.1 The investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the trial, should meet all the qualifications specified by the applicable regulatory requirement(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the IRB/IEC, and/or the regulatory authority(ies).

4.1.2 The investigator should be thoroughly familiar with the appropriate use of the investigational product(s), as described in the protocol, in the current Investigator's Brochure, in the product information and in other information sources provided by the sponsor.

4.1.3 The investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements.

4.1.4 The investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies). 4.1.5 The investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.

4.2 Adequate Resources

4.2.1 The investigator should be able to demonstrate (e.g., based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.

4.2.2 The investigator should have sufficient time to properly conduct and complete the trial within the agreed trial period.

4.2.3 The investigator should have available an adequate number of qualified staff and adequate facilities for the foreseen duration of the trial to conduct the trial properly and safely.

4.2.4 The investigator should ensure that all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their trial-related duties and functions.

 

Last updated 24 July 2019

Further information

If you have any questions relating to GCP training, please email the Research Office