I Request for approval of amendments
I Changes to research
Requests for approval of
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
'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
email requests for approval of amendments as follows:
- Attach the completed
for Approval of Amendments form
- Attach all relevant documents with changes
tracked. e.g. updated protocol, modules or NEAF, Resource Centre
- 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
research personnelFor 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
- Please remember to include CVs.
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
email@example.com with the subject field labelled 'Revised IB'
followed by the Project Number.
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.
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.
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
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
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.
Research Personnel Form