Research & Ethics Unit

 Amendments
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I Request for approval of amendments I Changes to research personnel I

Requests for approval of amendments

From time to time amendments are required to research projects. These are usually initiated by the researchers or by external study sponsors. Requests for approval of amendments must be completed according to the requirements below and emailed to research@alfred.org.au with 'Amendment' followed by the Alfred project number in the subject field. We do not require hard copies of your request.

Guidelines for submitting applications for approval of amendments

Requirements
please email requests for approval of amendments as follows:
  • Attach the completed Request for Approval of Amendments form
  • Attach all relevant documents with changes tracked. e.g. updated protocol, modules or NEAF, Resource Centre Declarations, advertisements.
  • Please only include material that is relevant
  • If submitting a sponsor-initiated Clinical Trial Protocol, please include a summary of changes to accompany these documents
Changes to research personnel
For changes to research personnel only, please label the email 'Change to research personnel' followed by the Project Number. This will ensure expedited review.
  • 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. You can find the latest PICF templates here.
  • Please remember to include CVs.
Revised Investigator's Brochures
Revised Investigator’s Brochures do not need to be submitted as a formal amendment unless there are associated changes to the Participant Information & Consent Form, protocol, or other study documents.

If a formal amdendment is not required, please complete the Request for Review of Updated Investigator's Brochures Form and email the form with the updated Investigator's Brochure and Summary of Changes document to research@alfred.org.au with the subject field labelled 'Revised IB' followed by the Project Number.

Review process

In most cases, the material submitted 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 material will be listed for discussion at the next Ethics Committee meeting. In some cases, the request can be reviewed and approved in the Ethics Office.

Approval

Provisional approval of amendments may be provided between sessions by the chairperson or his/her nominee but must be ratified by the full Ethics Committee at its next meeting.

Review fee

A review fee of $660 may be levied if amendments are initiated by a commercial sponsor. A tax invoice will be sent by The Alfred directly to the sponsor after submission of the amendment. The full mailing address of the sponsor (including name of contact person) should be included with the request for amendment.

Changes to research personnel

It is common for changes in staff to occur throughout the life of a project. When new people join your research team or others leave, please make sure you let the Ethics Office know.

Use the form below if there have been any 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.

There is no fee for approval of changes to research personnel.

If you would like approval for changes to other aspects of your project, please submit a Request for Approval of Amendments as detailed elsewhere on this page.

Changes to Research Personnel Form

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This page was last modified on 27/02/12


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