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    Pearls and pitfalls for principal investigators

    Interested in becoming a principal researcher? Read this first.



    5). Understand the regulatory environment

    It’s impossible to do a good job as a PI without a thorough understanding of the regulatory process and its requirements. Every site initiation visit (SIV) includes a review of good clinical practice (GCP) and the protection of human subjects. However, the PI’s understanding should go beyond these basics. 

    What are the relevant regulatory time lines related to starting the study, obtaining review and achieving approval? What is involved in a site inspection? What have been the challenges encountered by the sponsor during previous investigations of similar devices or drugs? The greater your understanding, the better job you can do in helping the sponsor reach the goal. 

    This list of pearls and pitfalls is not exhaustive by any means. But it is a start, whether you are just getting involved in clinical research or seeking to improve your performance as a PI.      

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