RPA RPA
Research Ethics and Governance Office

Clinical Trial SSA submissions

See sections: 
A – SLHD as the lead HREC and
B - SLHD is a site and NOT the lead HREC

All documents must be submitted in hard copy

SIGNATURES
Original signatures are required, not electronic signatures.

A: Where SLHD (RPAH Zone) is the lead HREC:
The following documentation must be completed and submitted to the office:

  1. SSA, signed by all the required persons
  2. Site versions of the approved Participant Information Sheets and Consent Forms 
  3. Site versions of any other documents to be made site specific (such as Flyers, Advertisements, Diaries)

The following are not required as there is a copy on file:
• NEAF/ HREA
• HREC approval letter
• or the majority of the documents submitted to the HREC.

We also require the regulatory documentation pertaining to the type of sponsorship as follows:

a) For commercially sponsored clinical trials we require:
• Medicine Australia Standard Forms of Indemnity (3 copies signed by the Sponsor)
• Relevant Medicines Australia Clinical Trial Research Agreement (3 copies signed by the Sponsor and the Principal Investigator)
 including only those Special Conditions which have been approved by the South and Eastern Border States including the NSW Ministry of Health's Legal Branch.
•Current Certificates of Insurance including:
- Cover of AUD$20 million for commercially sponsored research
- Cover of AUD$10 million for collaborative or co-operative research groups
- Must be in Australian Dollars
- Must state cover for clinical trials
- Must state an Australian Insurer’s name and Australian address

NB: CTN will not be submitted as its submission to the TGA is the responsibility of the Sponsor.

b) For collaborative-co-operative research group clinical trials we require:
• Relevant Medicines Australia Clinical Trial Research Agreement (3 copies signed by the Sponsor and the Principal Investigator)including only those Special Conditions which have been approved by the South and Eastern Border States including the NSW Ministry of Health's Legal Branch.
• If available, a Certificate of Insurance and Standard Forms of Indemnity would also be appreciated
NB: CTN will not be submitted as its submission to the TGA is the responsibility of the Sponsor.

c) For Investigator-initiated clinical trials where the SLHD is the sponsor we require:
CTN information - for the drug or device being used. The submission of the CTN to the TGA is the responsibility of the SLHD. The RGO is the nominated person to complete the submission to the TGA on-line. The RGO will liaise with the Principal Investigator during this process. The CTN Information Form is available on the website
FEE: The Investigator will be responsible for the submission fee to the TGA. After liaison with the RGO this can be either by credit card payment or the payment of an Invoice generated by the RGO and forwarded to the investigator. 

B: Where the lead HREC is from SLHD (CRGH) or any HREC accredited under the National Mutual Acceptance Scheme: 
The following documentation must be completed and submitted to the office:

HREA/ NEAF
• HREC Approval Letter
• All documents reviewed and approved by the lead HREC
• SSA, signed by all the required persons
• Site versions of the approved Participant Information Sheets and Consent Forms
• Site versions of any other documents to be made site specific (such as Flyers, Advertisements, Diaries)

We also require the regulatory documentation pertaining to the type of sponsorship as follows:

a) For commercially sponsored clinical trials we require:
• Medicine Australia Standard Forms of Indemnity (3 copies signed by the Sponsor)
• Relevant Medicines Australia Clinical Trial Research Agreement (3 copies signed by the Sponsor and the Principal Investigator)
 including only those Special Conditions which have been approved by the South and Eastern Border States including the NSW Ministry of Health's Legal Branch.
• Current Certificates of Insurance including:
- Cover of AUD$20 million for commercially sponsored research
- Cover of AUD$10 million for collaborative or co-operative research groups
- Must be in Australian Dollars
- Must state cover for clinical trials
- Must state an Australian Insurer’s name and Australian address

NB: CTN will not be submitted as its submission to the TGA is the responsibility of the Sponsor.

b) For collaborative-co-operative research group clinical trials we require:
• Relevant Medicines Australia Clinical Trial Research Agreement (3 copies signed by the Sponsor and the Principal Investigator)including only those Special Conditions which have been approved by the South and Eastern Border States including the NSW Ministry of Health's Legal Branch.
• If available, a Certificate of Insurance and Standard Forms of Indemnity would also be appreciated
NB: CTN will not be submitted as its submission to the TGA is the responsibility of the Sponsor.

c) For Investigator-initiated clinical trials where the SLHD is the sponsor we require:
CTN information - for the drug or device being used. The submission of the CTN to the TGA is the responsibility of the SLHD. The RGO is the nominated person to complete the submission to the TGA on-line. The RGO will liaise with the Principal Investigator during this process. The CTN Information Form is available on the website
FEE: The Investigator will be responsible for the submission fee to the TGA. After liaison with the RGO this can be either by credit card payment or the payment of an Invoice generated by the RGO and forwarded to the investigator.

NB: As these projects are approved by an HREC other than the SLHD

All study correspondence after you gain site authorisation
 should be addressed to the Research Governance Officer.
No documentation should be addressed to the Executive Officer as it will cause a delay in governance response.