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  • es338 replied to the topic Clinical Trial Roles in the forum Clinical Research Basics 6 years, 5 months ago

    Guidance for Clinical Trial Sponsors: https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm127073.pdf
    I would select to be a sponsor for clinical research because they are responsible for initiating the clinical investigation, documenting the research, and submitting the IDE with Regulatory.
    Sponsors are Medical/Clinical subject matter experts (SMEs) from a corporation who is innovating a new drug or device. Sponsors essentially research, prepare, manage, and document clinical research. They investigate and conduct preclinical studies to identify optimal parameters for the clinical study, such as safe dosages for human trials, identification of associated risks, or recommendations for clinical monitoring. From the preclinical trial results, the Sponsor creates the clinical trial protocol. They determine selections for locations, investigators, and create the case report form (CRF). During the clinical trial, sponsors ensure the study is conducted to comply with good clinical practices (GCPs). Once the clinical study is complete, sponsors prepare the documentation of the results and work with the company’s Regulatory department for submitting the clinical data to the appropriate regulatory agencies.
    I like the aspect of having the opportunity to research predicate clinical data, innovating the clinical trial protocol, managing and monitoring the clinical study, as well as being able to analyze the clinical results in either preparation for a regulatory submission or to evaluate findings to continue further research.