Source document

A source document is a document in which data collected for a clinical trial is first recorded. These data are usually later entered in the case report form. The ICH-GCP guidelines define source documents as "original documents, data, and records." Source documents contain source data, which is defined as "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."

The FDA does not define the term "source document."

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