Researchers need to keep the St John of God Health Care (SJGHC)
Ethics Committee and the SJGHC participating site(s) promptly and
regularly informed on the progress of their approved research
- Any adverse events or unexpected outcomes that may affect
continued ethical approval of the study. Refer SJGHC
Protocol on Adverse Event Reporting and SJGHC Local Site SAE/SUSAR
Form, also the guidelines for reporting of Protocol
Deviations and Violations.
- Any proposed changes in the research protocol. Refer
Checklist for Researchers Making Research Amendments (including
- When the study is completed or abandoned.
As a minimum condition of ongoing approval,
researchers need to forward to the Committee and the SJGHC
participating site(s), annual study progress reports, as well as a
final report on the study results and/or any subsequent