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Statements

Subject Item
dbr:Extraction
dbo:wikiPageWikiLink
dbr:Source_document
Subject Item
dbr:Debit_note
dbo:wikiPageWikiLink
dbr:Source_document
Subject Item
dbr:Deutsches_Wörterbuch
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dbr:Source_document
Subject Item
dbr:Purchase_journal
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dbr:Source_document
Subject Item
dbr:Purchase_returns_journal
dbo:wikiPageWikiLink
dbr:Source_document
Subject Item
dbr:Epiousios
dbo:wikiPageWikiLink
dbr:Source_document
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dbr:Credit_note
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dbr:Source_document
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dbr:Source_document
Subject Item
dbr:Source_document
rdf:type
dbo:Book
rdfs:label
Source document
rdfs:comment
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." 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."
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dbc:Pharmaceutical_industry dbc:Clinical_data_management dbc:Clinical_research
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2377367
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1045404086
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dbc:Clinical_data_management dbr:International_Conference_on_Harmonisation_of_Technical_Requirements_for_Registration_of_Pharmaceuticals_for_Human_Use dbr:Case_Report_Form dbr:Food_and_Drug_Administration dbc:Pharmaceutical_industry dbc:Clinical_research
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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." 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." The Food and Drug Administration (FDA) does not define the term "source document".
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2008
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wikipedia-en:Source_document
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dbr:Outline_of_clinical_research
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dbr:Source_document
Subject Item
dbr:Lemma_(morphology)
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dbr:Source_document
Subject Item
dbr:Bookkeeping
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dbr:Source_document
Subject Item
dbr:Cash_account
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dbr:Source_document
Subject Item
wikipedia-en:Source_document
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