Stay informed with the latest updates on coronavirus (COVID-19). Find out more >>

Monitoring program

  • The 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. 

    Frequently asked questions

    What is the purpose of the monitoring program?

    The purpose of the monitoring program is to review how research is conducted, and to detect, correct and prevent potential and existing problems. 

    The objectives of the 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.

    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.

    How will projects be selected for monitoring?

    Projects may be selected for a variety of reasons:

    • HREC request following approval of a new protocol as part of the approval process;
    • Due to the classification of risk;
    • Random selection;
    • A complaint; and/or
    • Annual report verification.

    What happens before a monitoring visit?

    Once a project has been selected for monitoring, the following will occur:

    • A letter will be sent to the Principal Investigator (PI) of the project, requesting a suitable time during the following month.
    • The date and time for the monitoring visit will be arranged.
    • The monitor will review the project's file and database entry to gather relevant information. This includes a review of the project through the information statement and protocol, as well as approval and version dates of study documents, for cross reference.

    How can researchers prepare for a monitoring visit?

    As outlined in the initial letter to the PI, the researchers must make available the following:

    • Study files and documents (including those in electronic form)
    • Patient data files, including medical records*, for the 3 subjects specified in the initial letter.
    • The signed consent form for every subject enrolled into 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
    • List of subjects (names and enrolment status)

    *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.

    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.

    What happens during a monitoring visit?

    During the visit the monitor will take notes via a combination of:

    • Inspecting the study documents
    • Asking members of the research team for answers to particular questions

    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. 

    How long will a monitoring visit take?

    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.

    What happens after a monitoring visit?

    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:

    • 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.

    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):

    • The integrity of the results
    • The risks to the research subjects
    • The ethical acceptability of the study
    • The insurance coverage

    If the items are not resolved, the HREC may request further steps are taken to address the issues.

    What if researchers disagree with the monitor’s report?

    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 sufficiently explained.

    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.