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Attribute

Schema Datatype or
Enumeration

UsageDefinitionBusiness Rules
OIDoidRequiredUnique identifier for the StudyEstimand element.The OID attribute value must be unique within the Study/MetaDataVersion.
NamenameRequiredHuman readable name for the Study Estimand.The Name attribute must be unique within the Study/MetadataVersion.
Level( Primary | Secondary | Exploratory )OptionalDefined Level for the Study Estimand

These are defined in concordance with the ICH M11 Clinical electronic Structured Harmonised Protocol Specification.

 [1] US Department of Health and Human Services F . 2017. Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER): Multiple Endpoints for Clinical Trials: Guidance for Industry. (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/multiple-endpoints-clinical-trials-guidance-industry)

[2] Biomarkers EndpointS and other tools (BEST) http://www.ncbi.nlm.nih.gov/books/NKB338448/