The Case Report Form

Abstract

Since sponsors ordinarily provide extensive guidelines concerning the details of completing their CRFs, these will not be covered in depth here. It is important to note that each sponsor has specific requirements as to how the company wishes specific data elements recorded. Sponsors may be willing to provide a sample completed CRF that can be used as a training document for the staff. Feedback as to the staff’s success in complying with the completion guidelines will be provided in the form of written requests for additional data or on-site reviews with the CRA staff. It is the investigator’s obligation to ensure that any valid errors noted in these reviews do not recur. The team’s response to any deficiencies in CRF completion will be a factor in judging its suitability for additional studies. Since most pharmaceutical companies evaluate their field forces’ performance partly by the quality of the CRFs submitted from their assigned sites, satisfied monitors are more likely to recommend a facility for placement of future projects. As a result, the CRAs will make fewer demands of the investigator’s time during the study.