In this section
You should submit all amendments and other post approval requirements on Ethics Review Manager (ERM). The Principal Investigator must obtain HREC approval for all amendments prior to implementation. Failure to do so risks researchers' legal indemnity, right to publication and
opportunity to seek future funding.
An amendment can include changes to the:
should your amendment change the risk profile of your project the amendment may
require review by the full HREC committee. We ask researchers to engage with
office prior to the amendment submission.
This may include but not limited to the following examples.
If you are unsure please contact the REG office.
You need to pay your
HREC Payment Fees in full when you submit a project or amendment. You need to complete the RCH HREC Fee Payment Form
or the payment remittance advice provided as proof of payment. We can only start the ethics review process once we have received your payment.
The relevant fees are outlined in the schedule of
Submission Fees. You do not need to submit this form if no fee applies.
You should submit amendments to the HREC that reviewed and approved your original application.
You need to submit the following documents when seeking ethical approval for amendments from the RCH HREC:
ERM - Amendment Form from the HREA
Signatures, if adding associate investigators or a new site and site PI:
If the protocol changes affect support provided by supporting department, please provide revised sign off:
Attached in ERM
One copy per supporting department
Attached in ERM, signed copy
* If the study is multi-site and the Melbourne Children’s Campus is a participating site please ensure any new or revised documents submitted are both the Master version and the Site Specific version based on the ethically approved masters*
If your study is multi-site and you have obtained ethical approval for the RCH from another HREC, please submit the following documents for governance authorisation:
ERM - Site Governance Amendment from the SSA
Please ensure the file name reflects the name of the document, as well as the version number
The RCH HREC do not accept a new phase or open label extension of a currently approved Clinical Trial to be submitted as an amendment. This would need to be submitted as a new application for review and approval.
PLEASE NOTE: A short summary needs to be provided with the submissions of open-label
extension studies (OLE). This will provide context of lead-in studies and
the differences between the OLE and original
The Coordinating Principal Investigator (CPI) is responsible for submitting amendments on behalf of all participating sites. Once the amendment has been approved, a copy of the approval letter and approved master documents should be forwarded to the Principal Investigator (PI) at each participating site to obtain governance authorisation.
An eCTN variation must occur if any of the details concerning the notification have changed. This includes (but is not limited to) the type of investigational product used, dose, route of administration and/or the manufacturer. An eCTN variation is also required if there have been changes to the site, sponsor or PI. Sponsors are responsible for submitting variations to the eCTN. As such, for all commercially sponsored clinical trials, this will be done by the pharmaceutical company or CRO. For all investigator initiated clinical trials where MCRI are the sponsor, please contact MCTC@mcri.edu.au for further information and instructions on submitting a variation.
All updated documents should be submitted as a amendment. All updated documents should also include a new version number and date to ensure ongoing accountability. The only exception to this is the correction of typographical errors, which can be corrected by the research team without having to update version numbers/dates or seek approval from REG. If you are unsure about whether to submit a amendment, please contact the office for advice.
Amendments are typically reviewed by the HREC Chair out of session. Where appropriate, a governance review is also undertaken concurrently by office staff. Only in exceptional circumstances will a amendment be escalated for full HREC review. This generally only occurs where the risk is considered high, or additional expertise is required. If your submission does require full HREC review, we ask researchers to engage with the REG office prior to the amendment submission and submit it to our office by the relevant meeting date deadline.
We aim to have amendments approved within two to four weeks. Additional delays may occur during busy periods. However, we will inform you of any delays.
The plain language page gives you information about how to write and submit your final letter.