Please print this form double sided.
This sheet is to be attached and included with your Clinical Trial Agreement (CTA), Form of Indemnity and SPA report. Please obtain signatures1-3before submitting to the Research Ethics and GovernanceOffice with your research proposal/application.
Your Contact Details
Name: / E-mail:
Work Contact Number: / Critical Date For Completion:
Project Title: (Insert below)
HREC Reference: ETH.
Rationale – (For CTA please advise if standard or non-standard arrangements and tag pages of note)
Clinical Trial Agreement(CTA) – Please sign the attached CTA, noting budgetary details on page xx
Indemnity – Please sign the attached indemnity form so that Canberra Hospital may be covered for the above mentioned trial
Associated Costs
Are there costs associated with this clinical trial? / YES NO
If yes, how it is funded? / Cost centre or SPA Number(mandatory)
Clearance levels – see overpage for more information
- Investigator Approval
Name: / Signature: / Authorisation Date:
- Division / Departmental Clinical Director
Name: / Signature: / Authorisation Date:
- Division / Departmental Executive Director
Name: / Signature: / Authorisation Date:
- Deputy Director-General, Canberra Hospital &Health Services Approval
Name: Ian Thompson / Signature: / Authorisation Date:
- Confirmation of HREC and ACTIA Approval (REGO Director)
Name: / Signature: / Authorisation Date:
This signed document^ signifies governance approval has been granted to begin the above named research project at ACT Health sites.
^must contain all five (5) signatures to be valid
Research governance definition:
‘an institutional framework to effectively oversee and administer research so that its conduct complies with relevant legislation and meets appropriate standards of quality, safety, privacy, risk and financial management’ (NHMRC)
Aspects of the framework:
Resources: human (staff and participants), material (pathology, pharmacy, clinic space, medical imaging etc)
Funding/Budget: pharmaceutical (or other) sponsors, research collaboration, grant funded, unit funded
Compliance: legislation, institutional policy, risk management, safety, privacy, ethical acceptability
Quality: knowledge, experience, standards
Monitoring: ongoing ethically acceptable, regular safety monitoring,
What are you agreeing to?
Principal Investigator: interest in the study, feasibility assessment completed, believe studyfits with the unit’s research plan, believe resources (human and material)are available, believe funding appears adequate (draft* budget provided; final budget will be confirmed at a later date)
Clinical Director: confirm availability of resources (human and material) for proposed study and fit with unit’s research plan,funding appears adequate (draft* budget provided; final budget will be confirmed at a later date)
Executive Director: confirm study is an appropriate use of resources (human and material) and fits with ACT Health’s Research strategy,funding appears adequate (draft* budget provided; final budget will be confirmed at a later date)
Deputy-Director General CHHS: agrees with recommendations above; endorses CTA (including final budget), endorses indemnity, endorses CTN/CTX
REGO Director:provides advice regarding financial arrangements, confirms appropriate ethical and governance reviews have been completed; confirms legislative requirements have been met; confirms insurance coverage has been agreed
*budget negotiations can take many months. It is standard practice for ACT Health/Canberra Hospital to proceed with ethical and/or governance assessments pending acceptance of final budget. The budget will be considered final upon receipt of a Clinical Trial Agreement (or similar) signed by the PI and endorsed by the Senior Business Advisor for final approval by the DDG-CHHS. Governance approval will not be granted until DDG-CHHS has signed this clearance sheet.
Site Governance Clearance Sheet Version 7 – Sept 2016