Amendments and Updated Documents
Site Information and Consent Forms
Where SLHD is the Lead HREC:
• After the amendment has been approved by the Executive Committee, forward an updated version of the site documents for authorisation for use at RPAH. (Do not send the documents for the site at the same time as those for the Executive as more changes may be requested and the site documents would then be incorrect)
• Include a cover letter confirming that ethical approval for the amendment was given.
• To ensure correct version control, please remember to update the site version number and date in the document’s footer.
• The updated site date should be a date after the date of the ethics approval letter.
• We do not require another set of Master documents as we would have them on file from the amendment submission to our HREC
Where another LHD is the Lead HREC please include:
• A cover letter
• A copy of the Amendment Request Form
• Copy of the HREC approval letter for the amendment
• Copies of any Master documents which have been updated and listed on the approval letter
• Site versions of the amended documents (if applicable)
• To ensure correct version control, please remember to update the site version number and date in the document’s footer
• The updated site date should be a date after the date of the ethics approval letter
Clinical Trial Agreements
Before submitting the documentation to the RGO please check that the Institution name, address and ABN number are correctly listed (see page 14). If incorrect please liaise with the sponsor and have the document corrected before submitting to the RGO. Then submit the following:
• Three copies of the Amendment signed by both the Sponsor and the Investigator
• A cover letter detailing the reason for the amendment ( such as Protocol Amendment, recruitment number changes, budget changes)
Updated Forms of Indemnity
The updated Form of Indemnity must always be submitted with a copy of the current Certificate of Insurance
When lead HREC: Where SLHD (RPAH) is the lead HREC the investigator should write a letter to the RGO stating that an updated IB has been reviewed and approved. They should include the version number and date of the IB and the ethics approval letter. I then will note the use of the updated IB at the sites within the SLHD (RPAH).
When NOT lead HREC: For site governance of IBs where we are not the lead HREC we require:
• Copy of the updated IB. This can be either:
- A hard copy with your cover letter and the applicable HREC approval letter, OR
- A cover letter including a hard copy of the Summary of Changes, the applicable HREC approval and an electronic copy of the IB which you can email to the RGO: firstname.lastname@example.org