Monitoring Research
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
including:
- 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
Study Extensions).
- 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
publications: