SC (Subject <X> Characteristics) SS (Subject Status) <X> VS (Vital Signs) <X> TU (Tumor <X> Identification) TR (Tumor <X> Response) RS (Disease <X> Response) Findings About FA (Findings About) <X> SR (Skin Response) <X> Relationships RELREC (Related <X> Records) SUPP<xx> (Supplemental <X> Qualifiers) Custom <DOMAIN NAME> <X> <(Domain Long Name)> <DOMAIN NAME> <X> <(Domain Long Name)> Supplemental Qualifiers List each SUPPQUAL variable in an individual row. Include one set per clinical study.
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.
phuse-tp001-study-data-standardization-plan-v1-8409.docx