Submit an amendment

Review process

The majority of amendments are reviewed out of session and do not require review at the HREC meeting nor submission by a certain deadline. When deemed necessary, amendments are sent to the scientific and/or ethics spokespersons for the project, both of whom are members of the HREC. They will determine whether the amendment can be approved by spokesperson review or whether more detailed consideration is required. If detailed consideration is required, the matter will be listed for discussion at the next HREC meeting.

Amendments to QA projects

To amend a QA project, prepare the following documents:

• A cover letter outlining the nature of the amendments and the rationale behind these changes
• Tracked and clean copies of the protocol, QA module and any other appendices/consent form
• Any updated HIS/Pathology forms or statement of approvals

Once complete, email the documents to RMH-QAreview@mh.org.au.

Amendments to HREC and/or Governance projects

Important: Guidelines for preparing general amendments

Consider whether the documents listed in the guide are appropriate for your particular amendment. Once you have confirmed a particular document is not required, please put this information in the amendment form (eg. “PICF update not required as project is closed to accrual”) to avoid a query further down the track.

1. If there are changes to any of the study document(s), tracked and clean copies of these documents must be submitted as part of the amendment.
2. If a study document is new (ie has not been submitted to the HREC before) this should be stated on the amendment form.
3. A study protocol should contain up to date information regarding all study processes including recruitment, consent and study procedures. Therefore, if an amendment will change any of these study processes, an updated protocol (tracked and clean) must be submitted. This is to ensure that any new investigators can pick up the latest protocol and be able to conduct the study as per the approved protocol.
4. To make sure your approval letters are correct, please take the time to carefully and accurately list the documents submitted on the amendment form. We will use this form to generate your approval letter.
5. If a Participant Information and Consent Form (PICF) update occurs, please ensure any new wording is in lay language.

Tips for Participant Information and Consent Forms (PICFs)

Lay language is defined as language that could be understood by someone with a reading age of 12 years old. Note PICF requirements below to ensure that the approval is not delayed in the review process:

• If a patient is likely to know certain medical terminology because of their condition, state this in the amendment form or as a comment on the tracked PICF so that we do not request alterations.

• The wording of ‘subject’ is not permissible so please change this to ‘participant’ where applicable within the new wording.
• Often a study Sponsor will insert the new wording from the global or AUS PICF template so please take the time to check that the wording in the Master/Site Specific PICF is acceptable to that of the HREC.

How to submit an amendment for review

1. Click here to open the email template: amendments@mh.org.au
2. Enter all information requested in the email template
3. Attach all documents for review to this email. See Guidelines to Specific Amendment Types below to find out which forms are required for your amendment submission.
4. Provide the project number in the subject of the email
5. An automatic reply will be sent to you to confirm receipt of the amendment by the Office for Research.

Please ensure that:

• Documents in the amendment are appropriately named with document type, version no, version date (eg. protocol version 3_1 Jan 2015) and that documents are not locked;
• The subject of the email includes the project number;
• The files are compressed before attaching to the email. If the file is too large please attach over a series of emails making it clear in the subject that this is what you are doing (eg. 2015.001_Protocol amendment 3_email 1 of 3).
• Each document is attached as a separate file, ie. not a combined document
• If the amendment includes documents that require an original signature such as CTNs, indemnities and/or contracts, please submit these in hard copy to the Office for Research with a copy of the amendment form. We will accept scanned signatures of the PI on amendment forms.

Guidelines to specific amendment types

In addition to the documents required for amendment review, all amendments submissions must also be accompanied by:

• Signed Amendment Request Form; and

• Office for Research Fee Form; and
• Relevant documents as outlined below.