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Clinical Trials Subcommittee
Hunter New England Human Research Ethics Rural Research Methods Support Group Clinical Trials Subcommittee Application Forms Newsletters Research Governance Contacts
The Clinical Trials Subcommittee (CTSC), advises the Hunter New England Human Research Ethics Committee on methodological and pharmacological aspects of applications to conduct clinical trials and innovative therapy in the Hunter New England Area Health Service (HNEAHS).
The Clinical Trials Subcommittee shall make one of the following recommendations to the HNEHREC in relation to every protocol it reviews:
- Approval
- Provisional approval, subject to satisfactory replies to questions raised by the Committee being provided within the timeframe stipulated in the correspondence.
- Deferral on the basis that significant changes or additional information are required
- Not approved
Where approval has been recommended subject to provision by the investigator of satisfactory
replies to the CTSC's concerns, such replies will be considered by the HNEHREC, but may be referred back to the CTSC for further advice.
Membership
- Clinical pharmacologist
- Pharmacist with appropriate experience
- A statistician experienced in the design of clinical trials
- Persons with research experience and/or expertise relevant to the areas of research reviewed by the Committee.
- A Clinical Research Nurse
- Professional Officer (Research Ethics) (non-voting member)
Clinical Trials Subcommittee Terms of Reference 
(121k)
Notes:
The Same application form will be reviewed by the Clinical Trials Subcommittee Group and the Hunter New England Human Research Ethics Committee.
The Professional Officer (Research Ethics) will determine whether an applications needs to be reviewed by the Rural Research Methods Support Group prior to being considered by the Hunter New England Human Research Ethics Committee.
Links
- Human Research Ethics Committees: Standards for Scientific Review of Clinical Trials
- Therapeutic Goods Administration - www.tga.gov.au/index.htm
- Note for Guidance on Good Clinical Research Practice (CPMP/ICH/135/95 - Annotated with TGA Comments
www.toa.gov.au/docs/pdf/euguide/ich/ich13595.pdf
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