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Amendments

  • Please use Ethics Review Manager (ERM) to submit all amendments and other post approval requirements. 

    Amendments should be submitted for HREC review as soon as possible. There are no submission deadlines for amendments.

    It is the responsibility of the Principal Investigator to ensure HREC approval is obtained for all amendments prior to implementation. Failure to conduct research according to an ethically approved protocol risks researchers' legal indemnity, right to publication and opportunity to seek future funding.

    An amendment may include (but is not limited to) changes to the:

    • Protocol, including recruitment strategies or data collection
    • Investigator Brochure (if applicable)
    • Information Statements and Consent Forms or other participant material such as letters, advertisements, questionnaires
    • Study Team, such as the addition or removal of new principal investigators and associate investigators. (We do not need to be notified about other study team members, but you must keep your study delegation log up to date as we may request this at any time for auditing purposes.)
    • Participating sites, such as the addition of new sites

    RCH HREC fee payment 

    Please note as of the 1 July 2019 the changes to the  HREC Payment Fees. These are payable in full at the time of the initial submission of a project or amendment.

    All payments that are submitted to the Research Ethics and Governance Office at RCH must be completed using this  form or the payment remittance advice provided (proof of payment).

    RCH HREC Fee Payment Form 

    There are three options for payment Credit Card, Electric Funds Transfer and Internal Cost Centre Transfer.

    If payment does not accompany the initial submission or amendment the Ethics review process will not be able to start until it has been received. 

    To determine whether fees are applicable to the review of your submission, please review the schedule of  Submission Fees. You do not need to submit this form if no fee applies.

    Ethical approval: single and multi-site

    Amendments should be submitted to the HREC that reviewed and approved the original application. 

    The following documents must be submitted 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 & tracked copies with updated versions & 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 Protocol changes affect support provided by Supporting Department, please provide revised sign off:

    Attached in ERM

    * 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 the study is multi-site and ethical approval for RCH has been obtained from another HREC, the following documents must be submitted 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 2-4 weeks. Additional delays may occur during busy periods, however, we will ensure you are informed if it is likely your submission will be delayed for any reason. 

    How do I submit a thank you letter?

    Please submit your thank you letter, with version number and date, as an amendment to the REG office. The Plain Language Adviser will review your letter and give you feedback. This Example Thank You Letter  gives you guidance on how to write your own letter. Once the Plain Language Adviser has approved your letter, you will get a letter from REG giving you clearance to send the letter to participants.