Interventional: COMPLETED CCYY-MM-DD ANALYSIS CDISC SDTM LEGACY Terminology <forecasted Allocation, ONGOING <date> FPV> Control Group, ADaM <version>/ Intervention Model, ADaM IG <version> MedDRA PLANNED Masking, (Adverse Events) Study Classification, ADaM <version> Primary Purpose define.xml <version> WHO-DD Observational: TABULATIONS (Medications) Time Perspective, LEGACY <version> Biospecimen Retention, Target Follow-Up, LOINC SDTM <version>/ Duration (Lab Test SDTM IG <version> Term) Expanded Access: SDTM <version> None This column is – define.xml <version> blank SNOMED CT (Indication) Refer to <version> clinicaltrials.gov study design permissible NDF-RT values7 (Pharm Class) <version> Please See Completion Guidelines for more UNII information (Active moiety) <version> Data Pool Data Pool Exchange Terminology Pool Description Identifier (List of Studies) Standards Standards
Interventional: Allocation, Control Group, Intervention Model, Masking, Study Classification, Primary Purpose Observational: Time Perspective, Biospecimen Retention, Target Follow-Up, Duration Expanded Access: None – This column is blank Refer to clinicaltrials.gov study design permissible values7 Please See Completion Guidelines for more information COMPLETED ONGOING PLANNED CCYY-MM-DD <forecasted FPV> ANALYSIS LEGACY ADaM <version>/ ADaM IG <version> ADaM define.xml <version> TABULATIONS LEGACY SDTM <version>/ SDTM IG <version> SDTM define.xml <version> CDISC SDTM Terminology <date> MedDRA (Adverse Events) <version> WHO-DD (Medications) <version> LOINC (Lab Test Term) <version> SNOMED CT (Indication) <version> NDF-RT (Pharm Class) <version> UNII (Active moiety) <version> Data Pool Identifier Data Pool (List of Studies) Pool Description Exchange Standards Terminology Standards
SDSP_Template.docx