Submit an amendment
For projects considered by the Ethics Committee after 2013, please submit your amendment, change to research personnel, revised Investigator's Brochure (IB) or development safety update report (DSUR) via our web-based ethics application management system ERA.
For projects considered at Ethics Committee meetings prior to 2014, please submit your amendment, change to research personnel, revised IB or development safety update report (DSUR) via email to firstname.lastname@example.org
Some projects considered prior to 2014 have been created on ERA, in which case the amendment, change to research personnel, revised IB or development safety update report (DSUR) should be submitted via ERA.
Amendments other than change to research personnel
An amendment request form must be completed and uploaded via ERA or sent via email. The principal researcher's (electronic) signature must be included if this form is not sent directly from the principal researcher's email address or uploaded by the principal researcher.
Uploads to ERA or emailed amendment requests should consider inclusion of the following:
- Completed amendment request form
If submitting an updated IB to the Alfred Hospital Ethics Committee for review, the Description of Changes field must include a statement on the impact to participants or the protocol.
If submitting a DSUR, the Amendment category field selection should be 'Other'. The Description of Changes field must state DSUR and include a statement on the impact to participants or the protocol.
- All relevant documents with changes tracked. e.g. updated protocol, participant information materials, resource declarations, advertisements
- If submitting a sponsor-initiated Clinical Trial Protocol, include a summary of changes
- If submitting an IB, include a summary of changes
- For externally reviewed projects, the amendment approval from the external HREC
- Amendment payment form (if relevant).
Only include material that is relevant.
If submitted via email - label the subject field 'Amendment' followed by the Alfred Project Number.
Where the Alfred Hospital Ethics Committee has reviewed the project
In most cases, the amendment will be sent to two reviewers who are usually members of the Ethics Committee. They will determine whether the amendment should be approved without further assessment or whether a detailed examination is required. If a detailed examination is required, the project and proposed amendment will be listed for discussion at the next Ethics Committee meeting. Provisional approval of amendments may be provided between sessions by the chairperson (or nominee) but must be ratified by the full Ethics Committee at its next meeting.
Low risk projects follow a similar process, except they are usually only sent to one reviewer.
If the amendment is only an updated IB or DSUR, it will usually be sent to one reviewer. If there are no queries or any queries have been resolved, the updated IB or DSUR will be acknowledged.
Where an external Ethics Committee has reviewed the project (The Alfred as accepting site)
The approved amendment will be checked by the Alfred Ethics and Research Governance Office. If the amendment can be authorised, the project and proposed amendment will be sent to the Director of Research (or delegate) for confirmation of authorisation.
Changes to research personnel
The Changes to Research Personnel Form should be completed when new people join the research team or others leave. Use the form if there have been changes to Principal Researcher/s, Associate Researcher/s, Research Assistant(s), Research Coordinator(s), Student Researcher(s) or any other members of the research team since the project was approved/authorised.
- For changes to research personnel submitted via email, label the subject field 'Change to research personnel' followed by the Alfred Project Number
- If the Participant Information & Consent Form has been changed (even if only to add or change researchers' names), a new version number and date are required in the footer of each page. Upload (ERA)/email the tracked PICF
- Include current CVs if not provided within the last 2 years
- If there is a change to the Principal Researcher, a revised Clinical Trial Research Agreement, CTN and/or indemnity may be required. Upload (ERA)/email revised documents and provide hard copies to the Ethics & Research Governance Office
- Refer to Being a researcher at Alfred Health for information about adding student researchers.
In most cases, requests for changes to research personnel can be reviewed and approved by the Office of Ethics and Research Governance staff. The exception is a change to the Principal Researcher.
If you would like approval for changes to other aspects of your project, please submit a request for approval of amendments as detailed above.
A fee may be levied for review of amendments. Please check the fee schedule for details and complete the amendment payment form for submission with the application.