Women's and Children's Hospital, Adelaide

Research at the WCHN

Human Research

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:

Global Health Network Training Centre: https://globalhealthtrainingcentre.tghn.org/
Syneos Health (formerly INC Research): https://www.shclinicalsiteeducation.com

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

Human Research

The Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC) responsibilities are outlined in its Terms of Reference. The HREC has responsibility to review, and where appropriate, approve research or research audit projects involving patients, patients’ families, patient tissue, patient information, and/or WCHN staff.

Protocols involving a drug or therapeutic substance are also reviewed by the Drug and Therapeutics Clinical Trials Group (DTCCTG). The DTCCTG is an advisory and recommending body to the WCHN HREC. Its responsibilities are outlined in its Terms of Reference.

Before commencing a research project or research audit, approval must be obtained from the WCHN HREC. In addition, research governance approval is required for all research projects before they may commence. 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 WCHN 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 WCHN HREC is a NHMRC certified Committee that operates in accordance with the principles set out in the National Statement on Ethical Conduct in Human Research. The National Statement is produced by the National Health and Medical Research Council (NHMRC); for more information on the NHMRC visit their website at http://www.nhmrc.gov.au.

For more information regarding submissions to the WCHN HREC see the relevant link below. Any queries can be discussed with the Executive Officer and/or Chair of the WCHN HREC - Refer to contact details on the Research Secretariat page.