Source document

For use of this term in accounting, see Category:Accounting source documents.

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."[1] 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."[1]

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

Examples of source documents


  1. 1 2 "Guideline for good clinical practice." (PDF). ICH-GCP. p. 7. Retrieved 12 September 2015.
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