Direct Access - CISMeF

Preferred Label : Direct Access;

Alternative definition : CDISC-GLOSS: Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. NOTE: The party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information. [ICH E6 Glossary];

NCI Metathesaurus CUI : CL540432;

Details

Origin ID

C142511;

UMLS CUI

C4684641;

Automatic exact mappings (from CISMeF team)
- Random access [UNESCO concept]
Semantic type(s)
- Functional Concept [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

You can consult :

recommendations
documents concerning education
documents for patients