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Why does the Eye and Ear require GCP training?

Compliance with GCP and GCP training is required by

  1. National Statement
  2. Good Clinical Practice
  3. Therapeutic Goods Administration
  4. The new National Clinical Trials Governance Framework

Most organisations require all clinical trial team members to have GCP training.  For example the following organisations, and others, currently require all staff to have GCP training:

  • Royal Melbourne
  • Peter Mac
  • All Monash Partners organisations such as Alfred Health

The TGA have recently completed a Pilot of GCP inspections 

https://www.tga.gov.au/consultation/consultation-good-clinical-practice-inspections-program

The Eye and Ear has been slow to make GCP training a mandatory requirement, although by 31 December 2021 we will require all staff involved in clinical trials to have GCP training. 

 

 

What have we done to provide training?

The Research Office has communicated the changes over a period of 5 years. 

We have provided several face-to-face and videoconference GCP training opportunities and staff also have an opportunity for undertaking online GCP training at their convenience.

 

GCP training is an Eye and Ear specific requirement to ensure quality and safety for clinical trials conducted by the Eye and Ear and involving the Eye and Ear.  It is related to the requirement to comply with the National Statement and other regulatory requirements as listed above.

 

Last updated 22 October 2020 

 

Extracts

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.