CENTRAL SYSTEM FOR ETHICAL AND SCIENTIFIC REVIEW OF MULTI-SITE CLINICAL TRIAL
The Hospital participates in the Victoria state-wide central system of ethical review of multi-site clinical trials.
|The Consultative Council for Human Research Ethics provides governance for the new system designed to streamline ethical review of multi-site clinical trials.|
The new system aims to:
- Provide a faster, more efficient process to conduct clinical trials at multiple sites and speed up product development for world markets.
- Improve delivery of new treatments to patients early in drug/device development.
|The Coordinating Office for Human Research Ethics provides secretariat support to the Consultative Council and coordinates operations of the new system to streamline ethical review of multi-site clinical trials.|
The Coordinating Office also provides support to users of the new system to ensure timely ethical review and a high standard of safety and research ethics review in Victoria.
A Clinical Trial is defined as: An interventional drug or device trial, radiation therapy, surgery, treatment and diagnostic procedure.
The central system for ethical and scientific review of multi-site research will apply to research involving interventional clinical trials.
These will include drug and device trials that are conducted by:
- Commercial sponsors
- Collaborative groups/Consortiums
- Investigator initiated groups
|The central system will apply to interventional clinical trials, as defined above, and studies associated with ongoing activities relating to trials that have been conducted. This may include observational research and evaluation of a trial, developing a registry and other post-marketing surveillance activities.|
|How to make an application|
|Details of how to make an application under this central system is available at http://www.health.vic.gov.au/clinicaltrials/ |
|Briefly, this involves the following steps:|
1. As RWH Human Research Ethics Committee is not an accredited reviewing Human Research Ethics Committee, multi-site projects that are to be conducted at RWH needs to be reviewed by one of the reviewing Human Research Ethics Committees accredited by the Consultative Council for Human Research Ethics.
2. A Site Specific Assessment (SSA) application needs to be submitted to the Research Governance Officer (RGO) at the RWH Research and Ethics Secretariat.
|For details of number of copies required to be submitted and other information, please contact the RGO (Mr Arthur Hui, Administrative Officer, Research and Ethics Secretariat).|
|SSA Application fees for commercially sponsored projects|
|Application fee for Site Specific Assessment for commercial sponsored projects is $1,650, (i.e. $1,500 + GST).|
The fee should be paid at the time of SSA submission. Cheque should be made payable to “The Royal Women’s Hospital”.