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loading...| Preferred Name |
Protocol |
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| Synonyms |
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| ID |
http://www.CareLex.org/2012/carelex.owl#Protocol |
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| Abbreviation | ||
| Category Code |
T101.10.11 |
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| Code |
C25320 |
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| Content Model |
eTMF |
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| Creator |
C.Schmidt CareLex |
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| Cross Reference |
032 |
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| Definition |
A formal document that describes a complete plan of research activity in the framework of a clinical study: objective(s), design, methodology, statistical considerations, and organization of a trial. |
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| Display Name |
Protocol |
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| label |
Protocol |
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| Metadata |
Core; Country; Date; Organization; Organization Role; Process; Source; Study ID; Task |
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| Preferred Name |
Protocol |
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| prefixIRI |
Protocol |
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| prefLabel |
Protocol |
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| Regulation |
ICH 1.4.4, 8.2.2 |
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| Requirement |
Required |
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| Synonym |
Clinical Study Protocol, Protocol, Study Protocol, Full Protocol, Protocol Amendment |
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| Term Source |
CareLex |
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| Term Source URL | ||
| Term Type |
Content Type |
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| subClassOf |
http://www.CareLex.org/2012/carelex.owl#Core_Trial_Documents |
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