List of Studies and Standards Nonclinical Study Identifier Brief Title Study Type Study Status Study Start Date Exchange Standards Terminology Standards If value is unknown, specify TBD Please See Completion Guidelines for more information If value is unknown, leave blank or specify TBD COMPLETED ONGOING PLANNED ccyy-mm-dd <(forecasted Protocol sign)> TBD LEGACY SDTM v<version>/ SEND IG <version> SDTM vTBD/ SEND IG TBD tumor.xpt define.xml<version> define.xml TBD No Electronic Data Sponsor Defined Terminology CDISC SEND Terminology <date> <TBD> NONE Clinical Study Identifier Brief Title Study Design Study Status Study Start Date Exchange Standards Terminology Standards <Phase <x>> <Interventional/Observational/Expanded Access> Studies - <indication or Healthy Subjects or Healthy Volunteers>
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>
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>
HO (Healthcare Encounters) <X> MH (Medical History) <X> Findings DA (Drug Accountability) <X> EG (ECG Test Results) <X> DD (Death Details) <X> IE (Inclusion/Exclusion Criterion Not Met) <X> IS (Immunogenicity Assessment Specimen) <X> LB (Laboratory Test Results) <X> MB (Microbiology Specimen) <X> MS (Microbiology Susceptibility Test) <X> MI (Microscopic Findings) <X> MO (Morphology) <X> PC (PK Concentrations) <X> PP (PK Parameters) <X> PE (Physical Examination) <X> QS (Questionnaires) <X> RP (Reproductive System Findings) <X>
SC (Subject Characteristics) <X> SS (Subject Status) <X> VS (Vital Signs) <X> TU (Tumor Identification) <X> TR (Tumor Response) <X> RS (Disease Response) <X> Findings About FA (Findings About) <X> SR (Skin Response) <X> Relationships RELREC (Related Records) <X> SUPP<xx> (Supplemental Qualifiers) <X> Custom <DOMAIN NAME> <(Domain Long Name)> <X> <DOMAIN NAME> <(Domain Long Name)> <X> Supplemental Qualifiers List each SUPPQUAL variable in an individual row. Include one set per clinical study.