ABSTRACT
Paper case report forms (CRFs) or electronic forms (eCRFs) for use in electronic data capture systems are developed along with, or shortly after, the development of the clinical protocol to reflect the needs of the protocol in collecting the appropriate data for analysis. At some companies, the first draft of the CRF is created by a clinical research associate; at others, data managers prepare the initial version. Even if data managers are not responsible for the creation of the CRF, they should be closely involved in its review and approval as part of a cross-functional team.
