Source document

A source document is a document in which data collected for a clinical trial is first recorded. This data is usually later entered in the case report form. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (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]

For use of this term in accounting, see Category:Accounting source documents. For other uses, see Source text.

The Food and Drug Administration (FDA) does not define the term "source document".

Examples of source documents
  • Hospital records[1]
  • 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
gollark: If they had ALREADY done violent crime, this would not actually help anyone.
gollark: ...
gollark: I don't think there are many cases when "announce person's personal details to random people on the internet" is in fact the best approach.
gollark: > some cases
gollark: None of these are actually the common cases, though.

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