Source document

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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[edit]

  • Receipt
  • Deposite Slip
  • Invoice
  • Cheque
  • Bank Statement
  • Cash Register Roll (CRR)
  • Hospital records
  • Clinical and office charts
  • Laboratory notes
  • Memorandum
  • 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
  • Records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial

References[edit]

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