Amendments

There are guidelines for submitting applications for approval of amendments or changes to research personnel.

From time to time amendments are required to research projects. Amendments are submitted for consideration at the ethics meeting but a sub committee reviews them.

Please use the Amendment Proforma (see link below), which includes a summary of changes to accompany these documents

• Provide one (1) copy of amendments involving low or negligible risk such as an administrative correction.
• Provide four (4) copies of amendments involving greater than low or negligible risk
• Provide seventeen (17) copies of amendments involving significant issues such as a substantial change to protocol.
• The relevant documents are to have changes tracked. Added text is to be highlighted or underlined, and deleted text struck through
• Please include only material that is relevant
• 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.

Please note that commercially sponsored trials accrue a fee. Please see the ‘Fees’ section for more information.

Click on the link below to download the Amemdment Proforma.

Amendment Proforma