病例报告表（Case Report Form / CRF）

病例报告表：指按照试验方案要求设计，向申办者报告的记录受试者相关信息的纸质或者电子文件。¹⁾

Case Report Form (CRF)：A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.²⁾

Electronic Case Report Form (e-CRF): An auditable electronic record designed to record information required by the clinical trial protocol to be reported to the sponsor on each trial subject.³⁾

注释CRF（Annotated CRF）：是对空白的CRF的标注，记录CRF各数据项的位置及其在相对应的数据库中的变量名和编码。⁴⁾