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    Pearls and pitfalls for principal investigators

    Interested in becoming a principal researcher? Read this first.




    3). A case report form (CRF) is not a case report article

    In medical school, we learn to record all the positive findings and all the pertinent negative findings. The CRF is a list of only those history and examination fields determined relevant to the clinical trial, and only those findings that fit in each of the fields need to be recorded.

    However, there is almost always an area for additional comments. Some PIs want to add a lot of detail, much as they would for a case report in a medical journal. Not only is this unnecessary, it can lead to queries and questions from regulatory authorities that complicate the review process without adding any significant information. 

    For example, some subjects may have a lot to say about their visual perception following cataract or refractive surgery, and they may use a vocabulary all their own. These subjective impressions are best captured through a validated questionnaire, so that their significance can be evaluated consistently among subjects and across trials. It’s not helpful to write down every adjective a patient may use to describe a halo. 

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