RESEARCH GOVERNANCE SITE SPECIFIC ASSESSMENT

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1 JAN SINGLETON

2 RESEARCH GOVERNANCE SITE SPECIFIC ASSESSMENT

3 Research is what I'm doing when I don't know what I'm doing. ~Wernher Von Braun

4 When are you approved to commence your research? Your study has received a C from ethics = Ethical Clearance Your goal is to obtain A = Approval to commence Obtained only through Governance Authorisation by CE Delegate

5 Why is the Site specific Assessment required? Identify Site Acceptability Financial Accountability & Transparency Identifies Resources Required Identifies Legal requirements & risks No longer requires signatures of all those associated with the research

6 What does it mean when the SSA asks for the following? Site = Metro South Site Description of Study = Plain Language, what the study wants to do at the site, and watch terminology Example Wording dose-ranging study : a clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful, anyone can understand this wording Principal Investigator & Contact Person = The Investigator at the Site Research will be undertaken, correspondence via the Investigator

7 NEW FORM : Research Contracts and Study Execution Form replaces need for signatures on the SSA Site authority Signature PI s Signature Finance & Department Head Authorisation = Department Head and Finance Manager at the site Mandatory Research Cost Centre = Department Research Cost Centre at the site Mandatory

8 Research Contracts Form Site Contact : Coordinator Metro South Site Authority Signature: QEII/LOGAN/REDLAND etc Principal Investigator: Metro South Investigator/Investigator accessing site Metro South Dept. Head: Signature required Metro South Finance. Head: Signature required Mandatory Metro South Dept. Research Cost Centre: Middle digit is _ or 766 _

9 When is an Agreement needed? Principal/Associate investigators are not employed by Metro South External body wishing to participate in research i.e. Commercial Company, University, Non for Profit Organisation Only the Metro South Chief Executive/Or Delegated person can sign as authority on any given agreement, Governance obtains this signature (make sure Sponsor and PI have signed first)

10 Public Health Act (2005) Approval - Accessing Site Data & Confidential information without Consent Step 1. Ethics Approval with Waiver of Consent Step 2. Metro South Site Data Custodian Approval to access data external institutions only Step 3. Director Generals Approval to release data Step 4. Provide Approval letter to Research Governance Officer

11 Site Specific Documents Multi Site Study HREC approved Master Site Specific Form Tracked version Site Specific Form Clean version How should the Footer Look? Master Form Version 1. 1/1/16 PAH Form Version 1. 2/1/16

12 The Valid SSA SSA & Research Contracts Study execution Form with required Signatures, Cost Centre, supporting paperwork Site Approval i.e QEII, Redland, Logan, Communities etc HREC Approval Letter Quotes: Pathology, Pharmacy, Radiation Quote and report QCAT approval Letter of Risk Benefit for Metro South Sponsored interventional study CV Supporting documentation and Site Specific Forms Agreement PHA Approval Letter Indigenous Elders Support Queensland Forensice & Scientific Services HREC Approval

13 Amendments to the study HREC approval of amendment Addition or deletion of investigators Increase or decrease to the duties or participants Contract amendments Site Specific Documents Contracts Research and Study Execution Form Via Hard copy Reports Annual Report signed by PI Insurance Certificate Commencement Form signed by PI Via

14 Compliance NHMRC National Statement on Ethical Conduct in Human Research2007 NHMRC Universities Australian Code for Responsible conduct of Research 2007 Therapeutic Goods Administration Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95 Public Health Act 2005 (QLD), Part 4 Division 1S280 Guidelines under Section 95 & 95Aof the Privacy Act (Cth) 1988 Information Privacy Act 2009 (Qld) Queensland Intellectual Property Directive, 2013 Queensland Health Research Ethics and Governance Directive, 2013 Finance Management Practice Manual Coroners Act 2003 (Qld) s53 Hospital and Health Boards Act 2011 (Qld) Part 7.

15 Finally!! You have achieved an A Contacts for Governance are: Sonia Hancock : Research Governance Manager ( ) Jan Singleton: Monday to Wednesday Contracts officer Governance ( ) Rhianna Hardie: Thursday/Friday Contracts Officer Governance ( ) PAH-Research@health.qld.gov.au