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Site Specific Assessment (SSA) considers the legal compliance, financial management, accountability and risk management associated with research. SSA authorisation provides a separate review and is distinctly different from the ethical clearance process, however it is recommended that research project/s can be submitted for review to both departments for review in parallel.
The online SSA Form, used is developed via the ERM Applications portal. Only one SSA form needs to be submitted for multiple Metro South sites.
Complete research project risk assessment
|WI2023-292 Assessing and managing risk in research
Complete ethical clearance process.
Complete the site finance budget (mandatory)
Prepare research contracts and agreements (as applicable)
Prepare any relevant site specific supporting documents
Complete the relevant Research Contracts and Study Execution Form to obtain signatures from Head of Department, Business Finance Manager (if funds are over $10k) and MSH Facility Managers. Authorisation can also be obtained electronically via email and then uploaded via the ERM website.
Research Contracts and Study Execution (RCASE) Form single or multi-site
Review research fees.
Complete SSA form via the ERM Applications portal – declare conflicts of interest.
Upload supporting documents, sign and submit application via the ERM Applications portal
Please note: Submission processes differ if you conduct multi-site research and MSH is not the reviewing HREC. If any documentation has been updated after HREC review, forward it to our Research Governance Office available on the contacts page. Research governance authorisation cannot occur until HREC approval is granted.
All new SSA applications need to be submitted via ERM Applications
1. Login to ERM Applications or create an account if you do not already have one
2. Select the tile Create Sub-form from the list of Actions on the left-hand side
On the Create Sub-form page, select Queensland Health as your jurisdiction and SSA Form QLD as the Main Form type, then select Create
3. Complete the SSA and attach relevant supporting documents, including your site finance budget
Training material and Instructions on how to use the system can be found here. An SSA form can be generated after the HREA has been created.
Signatories Metro South Health facility managers as at June 2020 are as follows:
Princess Alexandra Hospital
Relevant Head of Department
QEII Jubilee Hospital
Bayside Health Service
Logan and Beaudesert Health Service
Metro South Mental Health and Addiction Services
Community and Oral Health Services
Inala Indigenous Health Services
Metro South Research Governance endorses use of electronic signature platforms, digital signatures OR electronic signature for execution of research agreements including Clinical Trials Research Agreements and the HTQ Passport agreements.
Metro South’s Legal team have stated:
‘Legally binding signatures recognised and accepted by Metro South Health for the execution of Agreements applied to research, are wet ink and, subject to inclusion of an appropriate consent and reliable and appropriate method clause in the Agreement, any combination of wet ink, electronic signing platform, digital signature or electronic signature’.
To accommodate this the following clause will need to be added as special condition to any given agreement, for Medicine Australia Agreements it can be inserted into Special Conditions Schedule 4 and Schedule 7:
(a) Each party consents to this document being executed by any other party through an electronic signing platform, digital signature or electronic signature.
(b) The parties agree that the method described in this clause is reliable and appropriate for the purposes of identifying the signing party and executing this document.
(c) By signing this document, all parties confirm that they have given prior consent, in accordance with applicable electronic transactions laws (including the Electronic Transactions (Queensland) Act 2001) for electronic transmission of any documents, notices or information required to be given under this document, for signing purposes or otherwise, so far as such means of communication have been indicated in this document by the provision of an email address.
SSA requirements include:
Note: If you are conducting a clinical trial, please view our specific information about clinical trials.
Change of Sponsor/CRO requirements:
Change of PI requirements: