Authorisation Document Submission /
Date: / Click here to enter a date. / Site: / Click here to enter text. /
SSA Ref: / 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. / Name of Site/Study Contact: / Click here to enter text. /
Purpose of Amendment/Submission
(Describe the change & any impact to the site) / Click here to enter text. /
Post Approval Submission Documents
Document Type
(Select from drop down) / Document Name / Version Number / Version Date / Received by RGO
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OFFICE USE ONLY
Received & Authorised for site use by Research Governance Officer (Name): / Click here to enter text. /
Signature: / / Date: / Click here to enter a date. /
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
HREC Amendment Approval Letter (Must list updated documents with Version/Date) / ☐ / ☐ / ☐
TGA CTN Acknowledgement or CTN Amendment
(Provided to the site after CTN lodgement by sponsor) / ☐ / ☐ / ☐
Study Protocol (Must be on HREC approval letter, must have version/date, summary of changes, covering letter to state site and participant impact) / ☐ / ☐ / ☐
Investigator Brochure (Must be on HREC approval letter, covering letter to state if the update required a change to the information sheet and consent form) / ☐ / ☐ / ☐
Master Participant Information Sheet & Consent Form (tracked and cleaned versions, must have version/date) / ☐ / ☐ / ☐
Site Specific Participant Information Sheet & Consent Form
(Tracked and clean versionsmust have version/date, covering letter to state changes to site and participant impact. If radiation is involved, site specific radiation details should be entered. This should match with the radiation report submitted to the lead HREC which should also be on their approval letter) / ☐ / ☐ / ☐
Radiation safety report/ Standard of Care declaration by PI
(Must be on HREC approval letter) / ☐ / ☐ / ☐
SAE
(Must be signed by PI. Must also go to the lead HREC – please check the relevant HREC for submission details. In a multi-site trial, it is your responsibility to send the SAE to the CPI) / ☐ / ☐ / ☐
Protocol Deviation
(only notify RGO if further action is required) / ☐ / ☐ / ☐
Annual Report/ Study Closure
(due on the anniversary of original HREC approval. Must be site specific and must go to lead HREC via CPI. See reviewing HREC site for relevant Annual report template) / ☐ / ☐ / ☐
Amendment to Research Agreement
(x3 Originals, signed by PI and Sponsor, covering letter must state reasons for amendment) / ☐ / ☐ / ☐
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) / ☐ / ☐ / ☐
DCSI Check
(where new research personnel are added to the study) / ☐ / ☐ / ☐
Confidentiality Deed for non-SA Health Staff
(where new research personnel are added to the study) / ☐ / ☐ / ☐
PostRGOAuthorisation Document Submission Cover Letter Template Version 6, 01/07/2016