SSA authorisation process

What is an SSA form?

• The online SSA form is the core document to manage the SSA authorisation requirements.
• The SSA form holds the information on how the research project will be conducted at the site/s, including mandatory signatures and related supporting documentation. 
• All research submissions require an SSA, allowing the institution to consider whether the research project complies legally (ie contractual arrangements, insurance and indemnity requirements are being addressed) it has sufficient physical resources and staff,  site is capable of conducting the research, financial management is in place, accountability is addressed and risk management is in place for the associated MSH participating site/s and any other relevant requirements are met.

What do I need to submit for my SSA?

The attached checklist and guideance form may assist with the completion of the SSA or for outstanding requirements:

• Site Specific Assessment (SSA) Checklist & Guidance Form (DOCX, 94.73 KB)

How do I submit my forms online?

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

1. 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.

Who is my facility manager?

Signatories Metro South Health facility managers as at June 2020 are as follows:

What is considered an acceptable signature?

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:

Electronic Execution

(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.

What elements comprise SSA authorisation?

SSA requirements include:

• confirmation of ethical clearance
• compliance with legislation, regulations, guidelines and codes of practice
• legal matters, including contracts and indemnity/insurance frameworks
• financial management, risk management and SSA
• institutional policies and procedures for responsible research conduct and managing research misconduct
• management of collaborative research
• reporting requirements.

How long does the SSA authorisation process take?

• Timely responses to queries between the principal investigator/trial coordinator (on behalf of participating site/s) and the reviewing Research Governance Office is crucial to avoid delay in commencing research. 

Where do I find more information regarding the site specific supporting documents?

Please see the following procedures for more information:

• Site Specific Assessment Procedure
• Ethical and Scientific Review of Human Research Procedure
• Participant Information and Consent Form Procedure

I am University employee/student, what agreements or contracts are required?

• Research undertaken by a University employee or student requires an agreement/contract or sub-contract between MSH (via the name of the relevant MSH site/facility) and the relevant university.
• You must request a contractual arrangement by contacting your University’s legal representative, see the following listed University contacts (as applicable).

• University of Queensland
  • Faculty of Medicine:
    med.rpms@uq.edu.au  +61 7 3443 7612
  • Faculty of Health and Behavioural Sciences:
    habs.researchcontract@uq.edu.au / +61 7 3365 6015 
     
• Queensland University of Technology (QUT)
  • Office of Research (grants or competitively funded projects) - Email: orresearchcontracts@qut.edu.au
  • Office of Commercial Services (other source of funding) - Email: ocscontracts@qut.edu.au
  • Note: QUT students need to contact their QUT primary supervisor for any assistance regarding agreement.
     
• Griffith University
  • research-contracts@griffith.edu.au / +61 7 3735 4105

What are the indemnity and insurance requirements and how does it apply to me?

• The indemnity protects a party for and against certain specific actions, claims or losses, and is required when an external organisation/researcher undertakes research in private rooms or wishes to utilise the services of the MSH site/facility.

Note: If you are conducting a clinical trial, please view our specific information about clinical trials.

• For more information:
  • Australian Clinical Trials Frequently Asked Questions: Indemnity and insurance arrangements for clinical trials in Australia
  • NHMRC - Indemnity and insurance arrangements for clinical trials

Is there a research fee associated with ethical clearance and SSA authorisation and when do I need to pay it?

• A research fee may be applicable to an application depending on individual circumstances. A fee is always applied to commercial research projects where there is a named sponsor in the application, and they are invoiced directly - so please ensure the relevant invoicing details are included.
• For non-commercial studies, a fee may still be applicable depending on whether the clinician or researcher is from MSH, Queensland Health or an external party.
• Should a clinician or researcher have any further questions about whether a fee is applicable please contact us to discuss further.

How do I make an amendment to my research project?

• Post approval - amendments, reporting and closure

When there is a change of Sponsor, CRO or PI what are the Metro South Governance requirements?

Change of Sponsor/CRO requirements:

1. CTRA amendment
2. Updated indemnity (Commercially sponsored studies only)
3. Updated insurance certificate (Commercially sponsored and Collaborative research groups only)

Change of PI requirements:

1. CTRA/Contract amendment (as applicable)
2. Updated indemnity (Commercially sponsored studies only)