Pooled Studies Data Pool Data Pool Pool Exchange Terminology Pool Description Identifier (List of Studies) Status Standards Standards CURRENT ISS <any additional information, such as certain domains> ANALYSIS Sponsor Defined LEGACY Terminology PLANNED ISE <any additional information, such as certain domains> ADaM v<version>/ CDISC SDTM ADaM IG <version> Terminology <date> ADaM <TBD> define.xml <version> MedDRA ADaM vTBD/ (Adverse Events/ ADaM IG TBD Medical History/ <other>) ADaM Initial <version> define.xml TBD Final <version> Initial TBD TABULATIONS Final TBD LEGACY WHO-DD (Medications) SDTM v<version>/ SDTM IG <version> <version> <TBD> SDTM define.xml <version> LOINC (Lab Test Term) <version> SDTM vTBD/ SDTM IG TBD <TBD> SDTM SNOMED CT define.xml TBD (Indication) <version> <TBD>
Pooled Studies Data Pool Identifier Data Pool (List of Studies) Pool Status Pool Description Exchange Standards Terminology Standards CURRENT PLANNED ISS <any additional information, such as certain domains> ISE <any additional information, such as certain domains> ANALYSIS LEGACY ADaM v<version>/ ADaM IG <version> ADaM define.xml <version> ADaM vTBD/ ADaM IG TBD ADaM define.xml TBD TABULATIONS LEGACY SDTM v<version>/ SDTM IG <version> SDTM define.xml <version> SDTM vTBD/ SDTM IG TBD SDTM define.xml TBD Sponsor Defined Terminology CDISC SDTM Terminology <date> <TBD> MedDRA (Adverse Events/ Medical History/ <other>) Initial <version> Final <version> Initial TBD Final TBD WHO-DD (Medications) <version> <TBD> LOINC (Lab Test Term) <version> <TBD> SNOMED CT (Indication) <version> <TBD>
phuse-tp001-study-data-standardization-plan-v1-8409.docx