Amendments

The Alfred Research & Ethics Unit

Amendments

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

From time to time amendments are required to research projects. These are usually initiated by the researchers or by external study sponsors. Notifications of protocol amendments must be made in writing and addressed to the Ethics Manager, Alfred Research & Ethics Unit, The Alfred hospital, 55 Commercial Road, Melbourne, Victoria 3004.

Guidelines for submitting applications for approval of amendments

Requirements
Please submit applications for approval of amendments as follows:

Provide two (2) copies of the completed Request for Approval of Amendments form
Provide two (2) copies of relevant documents with changes tracked on both copies. Added text is to be highlighted or underlined, and deleted text ~~struck through~~
Please include only material that is relevant
Please do not send clean copies of either original or updated versions of documents, unless a full Clinical Trial Protocol is required to be submitted
If a sponsor-initiated Clinical Trial Protocol is submitted, please include a summary of changes to accompany these documents

If the Participant Information & Consent Form has been changed, a new version number and date are required in the footer of each page. For changes to research personnel and consent procedures, please provide two (2) copies of all documents.

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.

Review process
Copies of 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.

Approval
Provisional approval of protocol 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 10/11/08

URL: http://www.alfredresearch.org/ethics/amend.htm