http://debianws.lexgopc.com/wiki143/index.php?action=history&feed=atom&title=Source_documentSource document - Revision history2026-10-26T20:03:34ZRevision history for this page on the wikiMediaWiki 1.43.1http://debianws.lexgopc.com/wiki143/index.php?title=Source_document&diff=1674266&oldid=previmported>Ozzie10aaaa: Cleaned up using AutoEd2023-11-25T17:01:46Z<p>Cleaned up using <a href="/wiki143/index.php?title=WP:AutoEd&action=edit&redlink=1" class="new" title="WP:AutoEd (page does not exist)">AutoEd</a></p>
<p><b>New page</b></p><div>{{about||use of this term in accounting|:Category:Accounting source documents||Source text}}<br />
{{refimprove|date=March 2015}}<br />
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|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."<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=[[International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use|ICH-GCP]] |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/><br />
<br />
The [[Food and Drug Administration]] (FDA) does not define the term "source document".<br />
<br />
== Examples of source documents ==<br />
* Hospital records<ref name=ich/><br />
* Clinical and office charts<br />
* Laboratory notes<br />
* Memorandum<br />
* Cash memo<br />
* Debit note, Credit note<br />
* Pay in slip<br />
* Subjects' diaries or evaluation checklists<br />
* Pharmacy dispensing records<br />
* Recorded data from automated instruments<br />
* Copies or transcriptions certified after verification as being accurate copies<br />
* Microfiches<br />
* Photographic negatives, microfilm or magnetic media<br />
* X-rays<br />
* Subject files<br />
* Records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial<br />
<br />
==References==<br />
{{Reflist}}<br />
<br />
{{DEFAULTSORT:Source Document}}<br />
[[Category:Clinical research]]<br />
[[Category:Pharmaceutical industry]]<br />
[[Category:Clinical data management]]</div>imported>Ozzie10aaaa