Amendments must be presented on an Eastern Health Amendment Form and should clearly explain the reason for the amendment. Amendments to protocol should either be in strike through format or in a separate Summary of Changes document (which is preferred). Changes to previous consent forms should be in strikeout format so that both the previous wording and amended wording can be reviewed – please do not use highlighter pens, as this is lost during photocopying.

A strike through and clean copy of the revised documents are required.

During the course of the study, Investigator Brochures are updated from time to time. Please submit a Summary of Changes document with the updated 1B.

Note: There are occasions where an updated 1B meets the regulatory requirements for more than one study. The researcher may make arrangements with the office of Research and Ethics for one updated 1B to be submitted for more than one study by application in writing only. The application must clearly state that the arrangement will meet regulatory requirements.

Please use a REQUEST FOR APPROVAL OF AMENDMENT form for the following:

• Amendment to protocol only
• Amendment to Participant Information and Consent Form (PICF) only
• Amendment to protocol and PICF
• Updated Investigator Brochure

Liaison Between Sites

Where existing trials are running at more than one Eastern Health site, researchers must collaborate when submitting amendments.