Date: / Click here to enter a date. / Site: / Click here to enter text. /
SSA Submission Code: (generated from Online Forms) / Click here to enter text. / HREC Ref: / Click here to enter text. /
Study Title: / Click here to enter text. /
Name of Principal Investigator: / Click here to enter text. / Department: / Click here to enter text. /
Sub Speciality: / Click here to enter text. /
Name of Site/Study Contact: / Click here to enter text. /
P / Click here to enter text. / E / Click here to enter text. /
ANZCTR/Clinical Trials.Gov Registration Number(If Applicable): / Click here to enter text. / Trial Phase: / Choose an item. /
Sponsor Type: / Choose an item. /
Global Sponsor (if applicable): / Click here to enter text. /
Clinical Research Organisation (if applicable): / Click here to enter text. /
Supporting Documents for SSA – Please also refer to document checklist
If your study was also submitted to the Aboriginal Health Research and Ethics Committeeplease attach the approval letter.
If your study involves radiationplease attach the radiation report or standard of care declaration by PI.
Document Type
(Select from drop down) / Document Name / Version Number / Version Date / Received by RGO
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Other relevant information for the RGO: / Click here to enter text.
OFFICE USE ONLY
Name of Reviewing Governance Officer:
Signature: / Click here to enter text.
/ Date: / Click here to enter a date. /
SSA Reference Number
(Generated by RGO - please use this reference number in all future correspondence with the Research Governance Officer / Click here to enter text. /
RGO Comments:
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Research Governance supporting documents checklist
To avoid delays, please ensure all study documents are labelled with a version number and date that corresponds with the ethics approval letter
Document Name / Attached
Yes / No / N/A
Completed SSA (Must be signed by all relevant persons e.g. Head(s) of Department,SA Health Finance delegate) / ☐ / ☐ / ☐
HREC Approval Letter (Must be listed as a study site) / ☐ / ☐ / ☐
TGA CTN Acknowledgement
(*If available* - provided to the site after CTN lodgement by sponsor) / ☐ / ☐ / ☐
Study Protocol (Must be on HREC approval letter, Must have version/date) / ☐ / ☐ / ☐
NEAF/LNR Ethics Application Form (Must be on HREC approval letter) / ☐ / ☐ / ☐
Investigator Brochure (Must be on HREC approval letter) / ☐ / ☐ / ☐
Participant Information Sheet & Consent Form (Master, must be listed on HREC Approval Letter, Must have version/date) / ☐ / ☐ / ☐
Participant Information Sheet & Consent Form (Site Specific, Must have version/date) / ☐ / ☐ / ☐
Radiation safety report/ Standard of Care declaration by PI (Must be on HREC approval letter) / ☐ / ☐ / ☐
Medicines Australia Clinical Trial Research Agreement Clinical Trials Only(x3 Originals, signed by PI and Sponsor) / ☐ / ☐ / ☐
Other Research Agreement
(Must be reviewed by the research office prior to submission) Agreements are executed by the SA Health Institution, not by the individual researcher / ☐ / ☐ / ☐
Medicines Australia Form of Indemnity
Clinical Trials Only(x3 Originals, signed by Sponsor) / ☐ / ☐ / ☐
Insurance Certificate (From Third Party Sponsor/University/Employer outside of SA Health) / ☐ / ☐ / ☐
Advertising (Must have version/date, must be authorised by Media and Communications at the relevant LHN) / ☐ / ☐ / ☐
CV of Principal Investigator / ☐ / ☐ / ☐
Current DCSI Check
Refer to site’s local requirements or the DCSI website / ☐ / ☐ / ☐
ICH-GCP Certificate
(Clinical Trials Onlycontact RGO for LHN requirement) / ☐ / ☐ / ☐
Confidentiality Deed for non-SA Health Staff
Refer to site for form/document and any other requirements / ☐ / ☐ / ☐
SSA Research Governance Application Cover Template Version 6, 01/07/2016