Our office facilitates a good governance monitoring
program. We can monitor any human research project that has received approval at
the Melbourne Children’s Campus. We monitor about 10 - 20 projects each year.
What are the aims of the monitoring program?
The
aims of the monitoring program are to:
- ensure research is conducted
ethically, safely, legally and in compliance with the protocol, conditions of
Human Research Ethics Committee (HREC) approval and institutional policies and
procedures
- raise awareness of requirements
and promote researcher accountability
- ensure that the conduct of
research does not compromise the integrity of the results.
The 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 our office to
effectively monitor the conduct of research following HREC approval.
How will projects be selected for monitoring?
We select projects for monitoring for a variety of reasons such as:
- HREC request following approval of a new protocol as part of the approval
process
- the classification of risk
- random selection
- a complaint
- annual report verification.
How will I be notified of the visit?
Before a monitoring visit we will send a letter to the
Principal Investigator. We will arrange a suitable time for the visit to take place during the following month
How can I prepare for a visit?
You can prepare for a visit by making sure the monitor has access to:
- study files and documents, including electronic versions
- participant data files, including
medical records*, for the three subjects specified in the initial letter
- list of participants
- the signed consent form for every
participant enrolled in the study
- a member of the research team to
answer any questions
- a space for the monitor to sit and
review the documents
- the database** containing the study
data
*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
the RCH
Investigators' Responsibilities in Research Procedure.
The projects that are best prepared for a
monitoring visit are those that have been well managed from the onset. All
staff should comply 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.
What happens
during a monitoring visit?
During the visit the monitor will:
- inspect the study documents, and
- ask questions of the research team
The monitor will only include information in their report if it is relevant 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. This is 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.
How long will a monitoring visit take?
A visit for a clinical trial will take about four hours. Visits for other studies will take about two hours. If your study documentation is well ordered, your visit may be shorter.
You must make a member of the research team available to
answer questions for at least 30 minutes at the start of the visit and 30 minutes at the end.
What happens
after a monitoring visit?
After the visit the monitor will complete their report. Their report will focus on issues such as:
The completed report will be sent to the principal
investigator within two weeks of the visit.
The follow-up process will be as follows:
- From the date the report is sent,
the researchers are given one month to respond to any findings on the
action item summary, unless an urgent resolution is indicated.
- The line manager may be asked
to oversee the resolution of the issue and the researcher's response.
- The responses will be reviewed by the
monitor and 'closed' if the response details a resolution or planned
resolution.
- If the items are not resolved, an
'outstanding issues' reminder will be sent to the PI and, in some cases, their
Line Manager.
- Monitoring reports and researchers responses
will be filed for consideration by HREC.
The monitor may find items that could have a potentially
significant negative impact on the:
- integrity of the results
- risks to the research subjects
- ethical acceptability of the
study
- insurance coverage
The monitor may escalate these items to the HREC or require a response within a shorter time frame.
If the items are not resolved, the
HREC may request further steps are taken to address the issues.
What if I disagree with the monitor’s report?
You can respond to the items on the monitor's action summary. It is acceptable for you to propose different resolutions to those proposed by the monitor if you make a sufficient case for them.
If you have a complaint, or would like to
discuss the monitoring program, contact the Director, Research Operations.