ABSTRACT
In clinical trials, we use forms to collect data consistently across clinical sites (see “Introduction”). It is only when data is collected consistently and accurately that it can be used in the analyses performed to test the trial hypothesis. In clinical trials, the data collection forms are called case report forms (CRFs). Paper or electronic CRFs are developed along with or shortly after the development of the clinical protocol. The forms collect the data called for in the protocol and help to guide sites in complying with the protocol procedures.*
At most companies, clinical data managers prepare the initial version of a study CRF and shepherd the CRF through the review and approval process. Even if a data manager is primarily responsible for the CRF, this must be a collaborative effort involving everyone in the study team. A crossfunctional team is the only way to design a CRF that will collect the necessary data in a way that is clear and easy for the site to use, ef—cient for data management processing, and appropriate for analysis. The team must balance company standards with the needs of the individual study and take into account preferences of the team members and investigators. In weighing needs and preferences, the —nal deciding question must be: “Can the data collected by the CRF be analyzed to make decisions about safety and ef—cacy?”
