Regulatory Report

Preferred Label : Regulatory Report;

NCIt related terms : Reg Rept; Report;

NCIt definition : A type of report required by a regulatory agency.;

Alternative definition : BRIDG: A report that provides notification of an adverse event, product problem, and/or information that is relevant to either. A report typically includes causal association, management strategies, authorship, sender/receiver organizations, subject of adverse event, or name of product. EXAMPLE(S): An Expedited AE report - a report of a serious and unexpected adverse event that must be submitted within specific timeframes to the sponsor and regulatory agencies.; CareLex: A collection of reports filed with regulatory authorities across the conduct of a trial; including but not limited to Periodic Reports, Interim Reports, and Annual Reports. [NCI]; FDA: A submission that contains a new annual report, Periodic Adverse Drug Experience Report (PADER) or Periodic Safety Update Report (PSUR).;

Details

Origin ID

C97107;

UMLS CUI

C3273238;

Automatic exact mappings (from CISMeF team)
- Informing (procedure) [SNOMED CT concept]
- Rapport [LOINC component]
- Report [LOINC System]
- Report [EDAM data]
- Report [LOINC component]
- Report (record artifact) [SNOMED CT concept]
- Reported [LOINC method]
- Reported (qualifier value) [SNOMED CT concept]
- Reporter (occupation) [SNOMED CT concept]
- Reporting [ICNP action]
- report [MeSH concept]
- report [Radlex concept]
- report [OBI concept]
- report [IUPAC Term]
- reporter [SNOMED Notion]
- research report [MeSH Descriptor]
Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- CareLex eTMF Terminology [NCIt concept]
- FDA eCTD Terminology [NCIt concept]
- eCTD Submission Sub-Type Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

You can consult :

recommendations
documents concerning education
documents for patients