In previous blogs, we have discussed investigator oversight and how it relates to the overall protection of the rights, safety, and welfare of study subjects. We have also looked at investigator oversight and the relationship to device accountability. But how does oversight relate to the overall conduct of the research study?
In the FDA Guidance document describing Investigator Responsibilities, the investigator must ensure that there is adequate training for all staff who are participating in the conduct of the research study. While training is often provided at the onset of a trial through initiation visits, or investigator meetings, it’s also important to remember that this includes new staff that is hired after the initiation of the trial. When supervising the conduct of human subject’s research, the investigator must ensure that:
- Study personnel are qualified by training and experience to perform study related tasks that have been delegated to them
- Staff should be aware of the regulatory requirements and standards for the conduct of clinical trials, and for the protection of human subjects in research
- Staff should be competent to perform tasks, or have received training to perform their tasks
- Study personnel have an adequate understanding of the research
- Staff should be familiar with the purpose of the study as well as the protocol to be followed
- Study personnel follow the IRB-approved protocol, including the recruitment and consent procedures described in the protocol summary
- Staff must be kept apprised of any changes to the protocol and receive appropriate training as needed
Sometimes an investigator’s plan for providing adequate oversight of a research study falls short. Considerations for overseeing a trial should take into account the following:
- Is the study staff new, and relatively inexperienced
- Does the staff have competing priorities?
- How many studies are being conducted?
- What is the condition of the study population? Seriously ill subjects will demand more time from the research staff and likely have more intense protocol requirements
- How many subjects are enrolled at the site?
- Do the subjects follow-up at another location(s)?
The investigator must formulate a plan from the onset of the study which allows him/her to adequately maintain supervision of all study personnel during the conduct of the trial. Failure to do so can be detrimental to the overall outcome of the study as well as can lead to unwanted consequences for the investigator or sponsor (FDA Warning Letters). Just as an ounce of prevention is worth a pound of cure, an investigator’s diligent oversight can be worth a positive research experience for all who are involved.
Have you been witness to an investigator’s adequate display of oversight or lack there of in a clinical research study? We want to hear your experiences.
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