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You should submit all amendments and other post approval requirements on . The Principal InvestigatorÌýmust obtain HREC approval for all amendmentsÌýprior 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 brochureÌý
• PICFs andÌýother 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 up to date for auditing purposes
• participating sites, such as the addition of new sites

Please note: 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 theÌýREG officeÌýprior to the amendment submission.ÌýÌý

This may include but not limited to the following examples. Ìý

• If you are adding or changing the scope of a waiver of consent or opt-out approach to consent.
• If you are adding measures that pose a risk to participants that has not yet been considered.
• If you are adding investigative measures (genetic tests or other) that have additional ethical issues associated with them that have not yet been considered – e.g. the addition may result in clinically relevant findings that need to be reported to the individual or family members.Ìý

If you are unsure please contact theÌýREG office.Ìý

RCH HREC fee paymentÌý

You need to pay your ÌýSubmission Fees in fullÌýwhen you submit aÌýproject or amendment. YouÌýneed to complete the RCH HREC Fee Payment FormÌý or the payment remittance advice provided as proofÌýof payment. We can only start theÌýethics review process once we have received your payment.Ìý

The relevant fees are outlined in theÌýschedule of RCH HRECÌýSubmission Fees.ÌýYouÌýdo 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.Ìý

You need to submit theÌýfollowing documents when seeking ethical approval for amendments from the RCH HREC:

* 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*Ìý

Governance authorisation only - multi-site

IfÌýyour study is multi-site and you have obtained ethical approval for theÌýRCH from another HREC, please submit the following documents for governance authorisation:Ìý

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

FAQs

Can new phases or open label extensions (OLE) of Clinical Trials be submitted as an amendment?Ìý

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.Ìý

PLEASE NOTE:ÌýA 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 study.

Amendments to Investigator Initiated Trials (IIT) sponsored by MCRI

Researchers who have gone through the MCRI sponsorship committee process will require further consideration by the sponsorship committee for amendments where there is a substantial change to the budget, substantial increase on the recruitment target, length of the trial, addition of an outcome measure that adds to the cost of the trial, if the project goes from being national to international and in accordance with the advice you were given at the time of sponsorship.Ìý

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.Ìý

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. ÌýAn 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.Ìý

What if the amendment involves 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.Ìý

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, we ask researchers to engage with theÌýREG officeÌýprior to the amendment submission and submit it to our office by the relevantÌýmeeting date deadline.Ìý

How long does it take to approve an amendment?

We aim to have amendments approved withinÌýtwo to fourÌýweeks. 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 pageÌýgives you information about how to write and submit your final letter.