1. Monitoring- What is it?
1.1.2 Reports from researchers, at least on an annual basis and at the completion of the project.
1.1.3 Reports from sponsors and independent agencies (such as Data and Safety Monitoring Boards).
1.1.4 Review of adverse event reports.
1.1.5 Random inspections of research sites, data and consent documentation (discretionary).
1.2 Monitoring arrangements will be commensurate with the risk, size and complexity of the study . The degree of risk of each project, as agreed by the HREC, is minuted at the relevant HREC meeting.
1.3 For each project:
1.3.1 There are mechanisms for reporting and reviewing
1.3.2 Urgent safety related events at any site for which the SWSLHD is responsible are reported and acted upon
1.3.3 Serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) from any site for which the SWSLHD is responsible are reported and acted upon as appropriate
1.3.4 Where the project is a large multi-centre trial, a Data and Safety Monitoring Board (DSMB) is used and there is a mechanism for informing the HREC of any relevant emerging data from the DSMB
1.3.5 Where the project is a local trial, there is an identified person/s or committee (initially HREC Executive Committee) with suitable expertise to assist and advise the HREC about reports of serious adverse events
2.1 Coordinating/Principal Researcher
2.1.1 Notify the reviewing HREC that mechanisms for monitoring are in place, and for satisfying the review body that the mechanisms are appropriate to the research.
2.1.2 Conduct the research in compliance with the approved protocol.
2.1.3 Provide reports of the progress of the study to the HREC, at a frequency directed by the HREC in the initial approval notification (but at least annually), and related to the degree of risk to participants 5,6.
2.1.4 Inform the HREC, and seeks its approval, of amendments to the protocol including amendments that: are proposed or undertaken in order to eliminate immediate risks to participants; may increase the risks to participants; or significantly affect the conduct of the trial , & 7,8,9,10.
2.1.5 Notify the relevant HREC of any serious adverse events at any study sites according to the HREC procedures 9,10.
2.1.6 Inform the HREC as soon as possible of any new safety information from other published or unpublished studies that may have an impact on the continued ethical acceptability of the study or may indicate the need for amendments to the study protocol 9,10.
2.1.7 Inform the HREC, giving reasons, if the study is discontinued before the expected date of completion .
2.1.8 For studies with implantable medical devices, confirms the existence of, or establishes, a system for: tracking the participant, with consent, for the lifetime of the device; and reporting any device incidents to the Therapeutic Goods Administration (TGA).
2.1.9 Report serious adverse events or reactions to trial sponsors to meet the requirements of regulatory agencies, such as the TGA .
2.1.10 Meet the monitoring responsibilities of the Principal Researcher or research team under any Research Agreement .
2.1.11 Ensure that SWSLHD, as an institution, meets its monitoring responsibilities under any Research Agreement.
2.2.1 Monitoring responsibilities as detailed in the following documents:
2.2.3 Reporting serious adverse events or serious unexpected suspected adverse reactions to: regulatory agencies (such as, Therapeutic Goods Administration) to meet the conditions of approval to conduct a trial; and investigators to enable them to fulfil the conditions of ethical approval by an HREC.
2.3 Human Research Ethics Committee (HREC)
The types of monitoring that SWSLHD employs are:
2.3.1 Reports from researchers of unforeseen events that may affect the continuing acceptability of the study ,
2.3.2 Reports from researchers, at least on an annual basis and at the completion of the study
2.3.3 Reports from sponsors and independent agencies (such as Data and Safety Monitoring Boards)
2.3.4 review of adverse event reports
2.3.5 random inspections of research sites, data and consent documentation (discretionary) 12,13 . Such inspections will consist of meeting with the Coordinating/Principal Investigator at his/her office or other venue where the research is being conducted, and will cover any/all of the following:
184.108.40.206 compliance with the approved ethics protocol,
The HREC will note items related to monitoring on the agenda (in the form of minutes of HREC Executive Meetings or new items for review by the full HREC as agreed by the HREC Executive). HREC members can request additional information or investigation, such as
2.3.1 Clinical Pharmacology expert
2.3.2 Device expert
2.3.3 Other relevant experts as required