If value is Please See Completion COMPLETED ANALYSIS Sponsor Defined ccyy-mm-dd unknown, Guidelines for more <(forecasted LEGACY Terminology specify TBD information ONGOING Informed Consent)> CDISC SDTM ADaM v<version>/ If values are unknown, PLANNED ADaM IG <version> Terminology leave blank or specify TBD TBD <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 SDTM v<version>/ (Medications) SDTM IG <version> <version> <TBD> SDTM define.xml <version> LOINC (Lab Test Term) SDTM vTBD/ <version> SDTM IG TBD <TBD>
If value is unknown, specify TBD Please See Completion Guidelines for more information If values are unknown, leave blank or specify TBD COMPLETED ONGOING PLANNED ccyy-mm-dd <(forecasted Informed Consent)> TBD 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 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>
phuse-tp001-study-data-standardization-plan-v1-8409.docx