Stay informed with the latest updates on coronavirus (COVID-19). Find out more >>

Amendments

  • 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:

    • protocol, including recruitment strategies or data collection
    • investigator brochure 
    • PICFs and other participant material such as letters, advertisements, questionnaires
    • addition or removal of Principal Investigators at all sites and Associate Investigators at the Melbourne Children’s Campus. You do not need to notify us about other study team members or Associate Investigators at other participating sites. However you must keep your study delegation log up to date for auditing purposes
    • participating sites, such as the addition of new sites

    RCH HREC fee payment 

    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.

    Ethical approval for single and multi-site amendments

    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:

    Document   Number of Copies

    ERM - Amendment Form from the HREA

    Submitted in ERM, signed by the CPI/PI  
    Revised documents - clean and tracked copies with updated versions and dates*
    Attached in ERM                                                                 
    New documents for approval Attached in ERM

    Signatures, if adding associate investigators or a new site and site PI:

    Attached in ERM

     If the protocol changes affect support provided by supporting department, please provide revised sign off:

    Attached in ERM

    One copy per supporting department 

     APPRU Supporting Department Declaration - if applicable 

    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* 

    Governance authorisation only - multi-site

    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: 

    Document   Number of Copies 

    ERM - Site Governance Amendment from the SSA

    Submitted in ERM, signed by the local PI                                      
    HREC Approval Letter, listing each of the approved master documents, including version numbers and dates Attached in ERM 
    Revised master documents with tracked site specific changes Attached in ERM 
    Any new approved documents to be used at the site Attached in ERM

    Please ensure the file name reflects the name of the document, as well as the version number and date 

    FAQs

    Who is responsible for submitting amendments for multi-site studies?

    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. 

    Do I need to vary the eCTN if the amendment involves a clinical trial?

    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. 

    What if the amendment involves minor administrative changes only?

    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. 

    How are amendments reviewed?

    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, you will be notified as soon as possible. 

    How long does it take to approve an amendment?

    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.

    How do I submit a final letter?

    The plain language page gives you information about how to write and submit your final letter.