Clinical Study Site Monitor

A Clinical Study Site Monitor is a Clinician (or clinical trial researcher) who is responsible for overseeing the conduct of a clinical trial at a specific research site.

• Context:
  • They can oversee, coordinate and conduct audits of multiple Clinical Research Projects.
  • They can ensure compliance with Good Clinical Practice (GCP).
  • They can provide independent regulatory oversight of all aspects of study conduct at the site, institutional, or network level.
  • …
• Example(s):
  • a healthcare professional that has been appointed by the clinical trial coordinating committee to supervise the clinical study,
  • …
• Counter-Example(s):
  • Clinical Trial Subject,
  • Clinical Trial Principal Investigator.
• See: Clinical Research Associate, Monitoring in Clinical Trials, Institutional Review Board (IRB), Clinical Trial Management System.

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References

2023a

• (Wikipedia, 2023) ⇒ https://en.wikipedia.org/wiki/Monitoring_in_clinical_trials#Functions_of_the_clinical_monitor Retrieved:2023-1-24.
  • Clinical monitors execute the monitoring plan laid out by the sponsors and investigators of a clinical trial. Monitors may be referred to by many different titles, such as: Clinical Research Associate, "on-site" monitor, Clinical Research Monitor, Study Site Monitor and Quality Specialist. The number of clinical monitors depends on the scale and scope of the trial.

    Almost all field monitoring requires regular visits to the site by the clinical research associate throughout the period of the study. On occasion, an extremely simple, low-risk study might be monitored almost exclusively by telephone except for the startup and closeout visits. Since the concept of "low risk" is subjective, this definition should be established in internal policies and procedures.

2023b

• chat
  • Q: Describe the role of a site monitor in a clinical trial? What is their goal? What might some of their challenges be? How could AI help them in their job?
  • A: A site monitor is a professional who is responsible for overseeing the conduct of a clinical trial at a specific research site. Their main goal is to ensure that the trial is conducted in accordance with the protocol and that all regulatory requirements are met. This includes verifying that the study is being conducted according to the approved protocol, monitoring the safety of the participants, and ensuring the integrity of the data collected.

    Some of the main challenges that site monitors may face include:

    • Ensuring that the study is being conducted in accordance with the protocol: This requires monitoring the study closely to ensure that all procedures are being followed correctly, and that the data collected is accurate and complete.
    • Monitoring the safety of the participants: Site monitors must ensure that the trial is conducted in a manner that minimizes the risks to the participants and that any adverse events are reported and tracked appropriately.
    • Ensuring the integrity of the data: Site monitors must ensure that the data collected is accurate, complete, and properly recorded. They must also ensure that the data is stored and handled securely to maintain the confidentiality of the participants.
    • Coordination with multiple parties: Site monitors have to coordinate with the different parties involved in the trial like the sponsor, CRO, and the study site to ensure the trial is running smoothly.
  • Artificial intelligence (AI) could help site monitors in several ways, such as:
    • Identifying potential issues: AI algorithms could be used to analyze data from the trial and identify potential issues that may need to be addressed by the site monitor.
    • Streamlining data collection and monitoring: AI could be used to automate data collection and monitoring, making it easier for site monitors to stay on top of the trial and ensure that all regulatory requirements are met.
    • Identifying patterns in data: AI could be used to identify patterns in the data that might indicate a safety concern or a problem with the study, allowing site monitors to take action quickly.
    • Automating follow-ups: AI could help in automating the follow-ups with the different parties involved, reducing the administrative burden on the site monitors.

2023c

• "PS Clinical Site Monitor."
  • QUOTE: ... This position offers an exciting opportunity to be part of a collaboration with Clinical and Translational Science Institute (CTSI), Clinical Research Support Office (CRSO) and the Department of Pediatrics. This role is responsible for overseeing, coordinating and conducting audits of multiple clinical research projects within the University of Utah and other clinical sites. Position provides independent regulatory oversight of all aspects of study conduct at the site, institutional, or network level. Ensures compliance with University policies, Food and Drug Administration (FDA ) and Office of Human Research Protection (OHRP ) regulations, Good Clinical Practice (GCP ), and state and federal guidelines. Expertise in human subject research and experience working with the FDA and ICH GCP are required. Must have the ability to Independently perform all on-site or remote monitoring activities. ...

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