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    Pearls and pitfalls for principal investigators

    Interested in becoming a principal researcher? Read this first.



    4). Know your expenses

    The clinical trial agreement (CTA) between the PI and the sponsor will spell out the compensation for conduct of the study, usually in terms of subjects and form completion. To effectively negotiate a fair agreement, the PI (or designee) must know what it will cost the site to run the trial per subject. An experienced site manager will know the cost for every test and procedure required by the protocol, as well as the costs associated with approval from an institutional review board (IRB), administration, surgery center services, and the PIs’ time. 

    If a sponsor’s proposal doesn’t net a profit, one may still decide to participate in a study if the value of participation includes important intangibles—at least one will know why one is participating. 

    On the other hand, one may wish to participate in a lucrative, but not particularly exciting trial to enhance the site’s bottom line. In either case, these decisions cannot be made in the absence of knowledge. 

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