개개 피험자별로 계획서에서 규정한 정보를 기록하여 의뢰자에게 전달될 수 있도록 고안한 인쇄되거나 전자 문서화된 부록

① A printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor for each trial subject.

② A record of clinical study observations and other information that a sutdy protocol designates must be completed for each subject.