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Which one is not a role taken by the clinical investigator?

-Reports adverse events within 10 days to the sponsor and IRB
-Gets informed consent from the trial subjects
-"Initiates, manages, and finances the trial"
-Maintains study files for at least 2 years after drug marketing approval
-Adhere to the protocol's inclusion and exclusion criteria for choosing trial participants

1 Answer

6 votes

Final answer:

The role of 'Initiates, manages, and finances the trial' is not typically taken by a clinical investigator but by the trial's sponsor. Clinical investigators' responsibilities include reporting adverse events, obtaining informed consent, adhering to the trial criteria, and maintaining study files.

Step-by-step explanation:

The role that is not typically taken by a clinical investigator is “Initiates, manages, and finances the trial.” This role is generally handled by the trial's sponsor, which could be a pharmaceutical company or a research institution. Clinical investigators are primarily responsible for conducting the trial, which includes reporting adverse events to the sponsor and the Institutional Review Board (IRB) within specified timeframes, obtaining informed consent from trial subjects, adhering strictly to the protocol's inclusion and exclusion criteria when choosing participants, and maintaining study files for the required time period post drug marketing approval.

As part of the clinical trial process, a Clinical Trial Coordinator may play a crucial role in the day-to-day management which includes coordinating schedules, maintaining detailed notes, and working with healthcare professionals to facilitate the trial. However, the initiation, management, and financing of the trial are tasks typically handled by the sponsor of the study, based on guidelines from agencies like the FDA and IRB.

User Andrew Stromme
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