Women's and Children's Hospital, Adelaide
Research Governance

Good Clinical Practice (GCP) training

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical research that involves the participation of human participants. Compliance with GCP provides public assurance that the rights, safety, and well-being of clinical research participants are protected, consistent with the principles of the Declaration of Helsinki, and that the research data is credible.

As part of the implementation of the National Clinical Trials Governance Framework and the Therapeutic Goods Administration (TGA) GCP Inspection Audits, investigators will be required to undertake GCP training and subsequent refresher training to meet compliance as mandated by SA Health.

The various Health Networks are working with SA Health towards ensuring that all staff involved in any clinical research (not only those involved in the design and conduct of clinical trials) undertake GCP training and hold a current certificate in GCP. This includes principal investigators, associate investigators, trial managers/coordinators and research nurses etc.

To ensure WCHN is compliant with the minimum training requirements, all staff (WCHN, SAHMRI, University etc) involved with undertaking any clinical research at WCHN must undertake GCP training. Evidence of GCP training will be part of the research ethics and research governance approval processes.

Initial certification is usually undertaken face-to-face with an accredited provider. However, due to COVID-19, SA Health is yet to advise if face-to-face training will be required for those undertaking GCP training for the first time, so on-line GCP training is deemed appropriate.

There are various free and user-pay GCP training courses available that meet the TransCelerate GCP training minimum criteria and provide evidence of compliance by staff when completed. WCHN will accept any course that meets the TransCelerate GCP training minimum criteria.These courses can be found via the following link:

https://www.transceleratebiopharmainc.com/gcp-training-attestation/training-providers/

As an example, the following two links are for free on-line GCP training courses:

Each requires the user to register for a login before commencing the training.

Researchers are encouraged to undertake such GCP training as a priority.

Please note: This is interim advice and further information will be provided when available from SA Health.

Research at the WCHN

Research Governance

Before a human research project may commence at Women's and Children's Health Network (WCHN) it must undergo a Research Governance Review, also known as Site Specific Assessment (SSA). This review is in addition to the Human Research Ethics Committee (HREC) review.

The WCH page link iconWCHN Human Research Ethics and Research Governance Standard Operating Procedures (SOPs) have been developed for research ethics and research governance matters. They apply to WCHN researchers, external researchers (including students) who are undertaking research at a WCHN site, WCHN research ethics committee members and other staff involved in the conduct and oversight of health and medical research at WCHN. The SOPS take into account the regulations, legislation, ethical and governance principles and guidelines for the responsible conduct of research.

The purpose of the Site Specific Assessment (SSA) form is to evaluate the assessment of the suitability of the resources at the site where the study will be conducted, and whether the site is sufficient to ensure satisfactory conduct and completion of the project. The Research Governance Officer (RGO) considers whether appropriate consultation and approval has been granted by the local decision makers (i.e. WCHN Human Research Ethics Committee and heads of affiliated departments) to permit the project to be undertaken at the site.

Applications for Research Governance Review at the WCHN must be made by completing the SSA Form found at Link iconGEMS.

The Research Governance Officer (RGO) will also require other documentation to be submitted together with the SSA for approval.  For this information, the Word iconWCHN SSA Submission Guidelines and Checklists will assist the applicant in ensuring which documents need to be provided to the RGO.

It is highly recommended that the Site Specific Assessment (SSA) application for research governance is submitted concurrently with the HREC application to avoid any delays in project commencement.

The study can only commence once the RGO and the Executive Director, Corporate Services have signed off on the SSA, and the RGO has provided the applicant with an authorisation letter or email for the study to commence at WCHN.

PDF iconSA Health Research Governance and Policy Directive and the  PDF iconWCHN Human Research Ethics and Research Governance Standard Operating Procedures (SOPs) have been developed for research ethics and research governance matters. They apply to WCHN researchers, external researchers (including students) who are undertaking research at a WCHN site, WCHN research ethics committee members and other staff involved in the conduct and oversight of health and medical research at WCHN. The SOPS take into account the regulations, legislation, ethical and governance principles and guidelines for the responsible conduct of research.

For further information on the SSA submission at WCHN, or any matters related to Research Governance, please contact:

Dr Carmel Murone
Research Governance Officer
Phone (08) 8161 6688
Email:
carmel.murone@sa.gov.au


Research governance requirements

WCH page link iconDocument Links


SA Health Policies

Link iconSA Health Research Governance Policy Directive

PDF iconSA Health – SSA advice to applicants

PDF iconSA Health – Clinical Trial Agreements Policy (March 2012)

last modified: 23 Mar 2021