# Source document

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> Markdown URL: https://mediated.wiki/source/Source_document.md
> Source: https://en.wikipedia.org/wiki/Source_document
> Source revision: 1186811109
> License: Creative Commons Attribution-ShareAlike 4.0 International (https://creativecommons.org/licenses/by-sa/4.0/)

{{about||use of this term in accounting|:Category:Accounting source documents||Source text}}
{{refimprove|date=March 2015}}
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](/source/Case_Report_Form). The [International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use](/source/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."<ref name=ich>{{cite web |url=http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf |title=Guideline for good clinical practice. |page=7 |publisher=[ICH-GCP](/source/International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use) |accessdate=12 September 2015}}</ref> 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."<ref name=ich/>

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

== Examples of source documents ==
* Hospital records<ref name=ich/>
* Clinical and office charts
* Laboratory notes
* Memorandum
* Cash memo
* Debit note, Credit note
* Pay in slip
* 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==
{{Reflist}}

{{DEFAULTSORT:Source Document}}
Category:Clinical research
Category:Pharmaceutical industry
Category:Clinical data management

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