In this section
Research Ethics and Governance Office facilitate a good governance monitoring
program to review how research is conducted, and to detect, correct and prevent
potential or existing problems.
Any human research project that has received approval at
the Melbourne Children’s Campus may be monitored.
Approximately 10-20 projects will be monitored per annum.
For additional information about the monitoring program,
please see the frequently asked questions on this page.
purpose of the monitoring program is to review how research is conducted, and
to detect, correct and prevent potential and existing problems.
objectives of the program are to:
RCH is required to monitor all
approved research in accordance with the National Health and Medical Research
Council (NHMRC) National
Statement on Ethical Conduct in Human Research (2007) (Updated 2018) .
Together, the monitoring program and the review of
annual progress reports allows the Research Ethics and Governance Office to
effectively monitor the conduct of research following HREC approval.
may be selected for a variety of reasons:
a project has been selected for monitoring, the following will occur:
As outlined in the initial letter to the PI, the researchers must make
available the following:
*If medical records need to be requested from Health
Information Services with advanced notice, the researchers must account for
this to make sure the correct and complete records are available.
**A researcher with authorised access who is familiar
with the database is required to assist the monitor on the database.
Researchers can conduct a review of their own files to
ensure they are current, complete and well organised. The expectations about
the study document that should be available are extensive, as specified in
Investigators' Responsibilities in Research Procedure.
Needless to say, projects that are best prepared for a
monitoring visit are those that have been well managed from the onset, with all
staff working in compliance with the protocol, the Investigators'
Responsibilities in Research Procedure and other applicable requirements.
Further, all staff delegated responsibilities in any
study should be aware of the Investigators' Responsibilities
Procedure, and must have training in the protocol, appropriate to their
duties in the study.
During the visit the monitor will take notes via a combination of:
The monitor will ask questions about processes used by
the study team, to ascertain how the study is conducted. However not all
details will be recorded in the report unless they relate to a particular issue
that is identified.
For the study subject data review, the monitor will
compare a sample of the collected study data to information in the source
documents, to ensure that it is verifiable and to check for discrepancies. This
step will often require the assistance of a member of the study team who has
access to the study database.
For studies with CRFs, this will involve comparing a
sample of data points from the CRFs of three specific subjects to their medical
records, as well as cross referencing with the database.
The visit will take approximately four hours for a clinical trial and
approximately two hours for other studies. Studies with well managed research
files can expect shorter visits.
A member of the research team must be available to
answer the monitor questions for at least 30 minutes at the start of the visit and 30 minutes at the end.
Following the visit, the monitor will complete a report from the
notes taken during the visit. The comments in the report will focus on any
apparent issues, including but not limited to:
The completed report will be sent to the principal
investigator within two weeks of the visit.
The follow-up process will be as follows:
Findings that are considered to have a potentially
significant negative impact on any of the following may be escalated to the
HREC and may require response within a shorter time frame (i.e. days or weeks
rather than 1 month):
If the items are not resolved, the
HREC may request further steps are taken to address the issues.
The researchers can respond to the items on the action item
summary as they see fit. Responses detailing resolutions that are different to
those suggested by the monitor are acceptable if they are
If a researcher has a complaint, or would like to
discuss an issue with any aspect of the monitoring program, they should contact the Director, Research Operations.