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- NCIT_C115574 IAO_0000115 "Records describing relevant findings and notifications of unexpected serious adverse reactions and other safety information, which is submitted by a sponsor to regulatory authorities, investigators, and Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs)." @default.
- NCIT_C115574 NCIT_NHC0 "C115574" @default.
- NCIT_C115574 NCIT_P106 "Intellectual Product" @default.
- NCIT_C115574 NCIT_P108 "Clinical Trial Expedited Safety Report" @default.
- NCIT_C115574 NCIT_P207 "C3899591" @default.
- NCIT_C115574 NCIT_P322 "CareLex" @default.
- NCIT_C115574 NCIT_P325 "Documentation that presents and summarizes the relevant findings and notification by the sponsor of unexpected serious adverse drug reactions and other safety information, which is submitted to regulatory authorities, investigators, Institutional Review Boards (IRBs) and/or Independent Ethics Committees (IECs). Reports may include but are not limited to CIOMS, MedWatch, Electronic Submission of AE Notification to FDA Reports, Analysis of Similar Events, cover letters, and/or country-specific reporting forms. [Adapted from TMF-RM]" @default.
- NCIT_C115574 normalizedInformationContent "100" @default.
- NCIT_C115574 referenceCount "1" @default.
- NCIT_C115574 hasExactSynonym "CIOMS Report" @default.
- NCIT_C115574 hasExactSynonym "Clinical Trial Expedited Safety Report" @default.
- NCIT_C115574 hasExactSynonym "Exped Safe Rept" @default.
- NCIT_C115574 hasExactSynonym "Expedited Safety Report" @default.
- NCIT_C115574 hasExactSynonym "Investigational New Drug (IND) Safety Report" @default.
- NCIT_C115574 hasExactSynonym "MedWatch" @default.
- NCIT_C115574 hasExactSynonym "Suspected Unexpected Serious Adverse Reaction (SUSAR)" @default.
- NCIT_C115574 inSubset NCIT_C114548 @default.
- NCIT_C115574 type Class @default.
- NCIT_C115574 isDefinedBy ncit.owl @default.
- NCIT_C115574 label "Clinical Trial Expedited Safety Report" @default.
- NCIT_C115574 subClassOf NCIT_C115574 @default.
- NCIT_C115574 subClassOf NCIT_C19498 @default.
- NCIT_C115574 subClassOf NCIT_C20181 @default.
- NCIT_C115574 subClassOf NCIT_C25198 @default.
- NCIT_C115574 subClassOf NCIT_C25375 @default.
- NCIT_C115574 subClassOf NCIT_C97331 @default.