loading...| Preferred Name | Document | |
| Synonyms |
documentation Document Type DOC Document |
|
| Definitions |
A physical object, or electronic counterpart, that is characterized by containing writing which is meant to be human-readable. |
|
| ID |
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C19498 |
|
| ALT_DEFINITION |
All records, in any form (including but not limited to written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken. [ICH E6 Glossary] An organized representation of information in publishable, human-readable form (that persists over time). EXAMPLE(S): Study Protocol, Adverse Event Report, Expedited Adverse Event Report, Institutional Review Board (IRB) Report, X-Ray Report, Lab Summary Report, Autopsy Report OTHER NAME(S): NOTE(S): 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). EXAMPLE(S): Adverse Event Report, Expedited Adverse Event Report, Institutional Review Board (IRB) Report, X-Ray Report, Lab Summary Report, Autopsy Report. NOTE(S): 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). |
|
| code |
C19498 |
|
| Concept_In_Subset |
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C159501 http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C61410 |
|
| Contributing_Source |
CDISC-GLOSS BRIDG |
|
| DEFINITION |
A physical object, or electronic counterpart, that is characterized by containing writing which is meant to be human-readable. |
|
| DesignNote |
Used here to organize a wide variety of concepts that are characterized by writing or text |
|
| FULL_SYN |
documentation Document Type DOC Document |
|
| label |
Document |
|
| Legacy Concept Name |
Document_Type |
|
| NCI_META_CUI |
CL414404 |
|
| Preferred_Name |
Document |
|
| prefixIRI |
Thesaurus:C19498 |
|
| Semantic_Type |
Intellectual Product |
|
| subClassOf |