Conducting a Clinical Trial at ECU
Research Development
ECU Research Services Support
During the initial development of your Clinical Trial, you are encouraged to contact Research Services to discuss the proposed research and to become familiar with the requirements of conducting a Clinical Trial at ECU. Within Research Services the following support is available:
- Your school’s Research Administration Officer to discuss the funding application.
- The Research Grants and Contracts team to discuss any relevant agreement or contracts.
- The Research Ethics Team to discuss the ethical requirements of a clinical trial.
- The Research Governance Team to discuss any specific governance requirements of a clinical trial.
- The Researcher Professional Development website provides support and training to help researchers build the knowledge, competencies and skills required to have a successful research career.
Clinical Trial - Training
All researchers involved with clinical trials should undertake training in Good Clinical Practice (GCP). The ‘Good Clinical Practice (GCP) in Australia’ online training course is specifically designed to assist clinical researchers within Australia understand the principles and foundations of GCP.
The Research Education and Training Program (RETProgram) is the online training platform of the Western Australia Health Translation Network (WAHTN). The RETProgram offers online health research-related training FREE for all ECU staff.
- ICH Good Clinical Practice RET Program - Online course
- Introduction to Good Clinical Practice CAHS Research Skills Seminar Series – Video
Please note that evidence of GCP training may be required for hospital HREC approvals and/or governance approvals.
Also, for a brief introduction to the clinical trials environment in Australia, you may refer to Australian Clinical Trials.
Project Development
It is recommended that when developing the study protocol, researchers should refer to the SPIRIT (Standard Protocol Items: Recommended for Interventional Trials) checklist, available under Downloads at this site. This document identifies the elements required for inclusion in the trial protocol and provides guidance to researchers to ensure important elements are fully addressed.
The SPIRIT 2013 Statement provides evidenced-based recommendations for the minimum content of a clinical trial protocol which is set out within a 33-item checklist.
Ethics Review
All research projects considered a clinical trial or clinical intervention will be reviewed by the full ECU HREC at their monthly meeting. Alternatively, an external Ethics Committee with expertise in reviewing clinical trials, such as Bellberry may be used.
When submitting an ethics application for a clinical trial, researchers must address the relevant sections in the National Statement on clinical trials in order for the HREC to review this as part of the application package.
Researchers should ensure that all aspects of the SPIRIT checklist are addressed within the ethics application.
Researchers are required to submit an ethics application through REMS. When completing the Proportional Review Checklist in REMS it is important to answer ‘Yes’ to the questions relating to Clinical Trial/Clinical Intervention in the mandated section. Further information regarding the ethics process can be accessed on the Research Ethics Website.
Prior Ethical Review
If the research has already undergone human or animal ethics review at another institution ECU can provide reciprocal ethics approval. This request must also be made via REMS when completing the Proportional Review Checklist.