15
JAN SINGLETON
JAN SINGLETON
RESEARCH GOVERNANCE
SITE SPECIFIC ASSESSMENT
Research Governance
“Research is what I'm doing when I
don't know what I'm doing.
~Wernher Von Braun”
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
Research Governance
Research Governance
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
Research Governance
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
Research Governance
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
Re
sea
rch
Go
ve
rna
nc
e 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 6 846 _ _ _ or 766_ _ _
Research Governance
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)
Research GovernancePublic 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
Research GovernanceSite 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
Research GovernanceThe 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
Research GovernanceAmendments 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 email
Research GovernanceCompliance
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.
Research Governance
Finally !! You have achieved an A
Contacts for Governance are:
Sonia Hancock : Research Governance Manager (07 3443 8046)
Jan Singleton: Monday to Wednesday Contracts officer Governance (07 3443 8050)
Rhianna Hardie: Thursday/Friday Contracts Officer Governance (07 3443 8050)
Email: [email protected]
