原始数据 Source Data / 原始文件 Source Documents

　　原始数据，又叫源数据：指临床试验中的原始记录或者核证副本上记载的所有信息，包括临床发现、观测结果以及用于重建和评价临床试验所需要的其他相关活动记录。¹⁾

　　Source Data：All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).²⁾

　　原始文件，又叫源文件：指临床试验中产生的原始记录、文件和数据，如医院病历、医学图像、实验室记录、备忘录、受试者日记或者评估表、发药记录、仪器自动记录的数据、缩微胶片、照相底片、磁介质、X光片、受试者文件，药房、实验室和医技部门保存的临床试验相关的文件和记录，包括核证副本等。源文件包括了源数据，可以以纸质或者电子等形式的载体存在。³⁾

　　Source Documents：Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).⁴⁾

　　源数据核查确认（Source Data Verification, SDV）：是指评价记录在临床试验病例报告表中的数据与源数据一致性的行为，以确保所采集数据的完整性、准确性和可靠性，使得临床试验项目日后重现成为可能。⁵⁾