Ethics committee approval is not a document that researchers should sign.

Original document (source document, SD) refers to original files, data and records. Its precise definition is “a first-hand record of any information about a subject or a certified copy of the original document.” Examples include hospital records, clinical and office charts, laboratory records, memos, subject diaries and checklists for evaluation, pharmacy dispensing records, data recorded by automated instruments, photocopies or printouts certified as accurate copies files, microfilm, photographic negatives, microfilm, magnetic carriers, X-rays, subject files, and records stored in pharmacies, laboratories and medical technology departments participating in the trial. These records need to be signed and dated before they can be considered original documents.

Original documents are evidence that clinical trial data are true, accurate, and reliable, and are also the source documents for all clinical trial report data. The original document is generally completed, signed and dated by the person who completed the study, observation or inspection. The subject's pinyin initials and trial number should appear on each page of the document, and any corrections should be signed and dated by the person making the correction.

The data in the original file is used to complete the CRF, so all data in the CRF should be consistent with that in the original record, and all data should be verifiable. Sometimes, researchers directly enter certain data into the CRF, and these parts become the original records. However, it is generally better to fill in all data in the subject's medical record file and then fill out the CRF accordingly. The subject's medical record file serves as the original document against which the CRF can be checked. This may seem tedious, but source documentation verification (SDV) is an indispensable procedure required by GCP and regulations.