loading...| Preferred Name | Document | |
| Synonyms |
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| Definitions |
An organized representation of information in publishable, human-readable form (that persists over time). |
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| ID |
http://www.bridgmodel.org/owl#Document |
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| definition |
An organized representation of information in publishable, human-readable form (that persists over time). |
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| example |
X-Ray Report Expedited Adverse Event Report Autopsy Report Institutional Review Board (IRB) Report Study Protocol Lab Summary Report Adverse Event Report |
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| has related match |
urn:Statistics_v1.0:Document urn:AE:Document urn:ICSRr2:document urn:RPS1:Documentation urn:C3PRv2.9:Consent urn:CTRR:Protocol_Title urn:CTRPv3.8:Document urn:CTRPv1.0:Document urn:CTRv1.0:Document |
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| Is Part Of | ||
| isAbstract |
false |
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| label |
Document |
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| note |
A document groups the various document versions and has the following characteristics: 1) Stewardship, 2) Potential for authentication, 3) Wholeness, 4) Human readability, 5) Persistence, 6) Global vs local context (the person that signs it is the author of all sections unless otherwise noted). Regulatory processes require the submission of documents from the Applicant to the Regulatory Authority. These documents are varied in focus and are often defined by the field of study or by the regulatory application requirements of the region or Regulatory Authority (e.g., Integrated Summary of Safety, Pharmacokinetics Written Summary). An organized representation of information in publishable, human-readable form (that persists over time). X-Ray Report Expedited Adverse Event Report Autopsy Report Institutional Review Board (IRB) Report Study Protocol Lab Summary Report Adverse Event Report |
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| prefixIRI |
bridg:Document |
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| prefLabel |
Document |
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| subClassOf |