Good clinical practice requirements for principal investigators of clinical trials
RMH requires that all principal investigators on clinical trials hold current good clinical pracitce (GCP) certification.
Investigators are required indicate in the governance application cover letter whether they have undertaken any GCP training and whether the training appears on the list of courses on TransCelerate Biopharma Inc. for the list of training providers. A copy of the course completion certificate should be included with the research governance application.
Investigators who do not hold current GCP certification should email the Manager Research Governance to arrange to undertake online GCP training provided by ARCS Australia.
What GCP training is acceptable?
RMH has adopted the minimum standards defined by TransCelerate Biopharma Inc. to recognise GCP training courses that contain material meeting the minimum criteria agreed to by its member organisations. Acceptable GCP training courses are those listed on TransCelerate Biopharma Inc.
ARCS GCP Training
The ARCS Applied GCP Training course meets the minimum standards defined by TransCelerate Biopharma Inc.
The course, Applied GCP Training for Investigational Sites and Sponsors Representatives (Certificates 1, 2 and 3), can be undertaken at the researchers own pace and takes approximately 8-10 hours to compete. The training is principally focused on best practice in clinical trials research but is sufficiently broad in scope so as to benefit all clinical researchers.
Upon completion of the program researchers should have a good understanding of the Australian regulations and ICH-GCP and ideas to consider when adhering to these during the conduct of research and also a clear understanding of the roles and responsibilities of all stakeholders in clinical research. Researchers who complete the training revive a certificate of completion which is valid for three years from the completion date.
This training is available to all RMH staff involved in clinical research. Contact the Manager Research Governance to arrange GCP training.
What is GCP?
The principles of GCP have their origin in the World Medical Association’s Declaration of Helsinki. The Declaration of Helsinki was responsive to the revelations of the Nuremberg trials conducted after World War II, and its drafters sought to ensure that human subjects involved in clinical research would, in future, have their rights, safety and well-being placed above all other considerations in clinical research. The document has been revised several times since it was first published in 1964.
The Declaration of Helsinki was used as a basis for the development of guidance for the conduct of clinical trials by the International Conference on Harmonisation (ICH). Originally developed for commercially sponsored late phase drug trials, this guidance has become known as the “Good Clinical Practice” (GCP) guidelines, even though the guidelines apply to clinical research rather than clinical practice. The GCP guideline details the requirements for trial documentation, protocol amendments, requirements such as indemnity, reporting lines for adverse events and provision of medical care for trial participants.
The Therapeutic Goods Administration (TGA) has adopted the European Union version of these guidelines in Australia. The TGA advice includes specific comments from the TGA relevant to the Australian context.