ADaM v TBD / CDISC SDTM SDSP-002-03 Planned ISS Relapsed or Refractory Ovarian or Breast – ADaM IG TBD Terminology Cancer - Interim Analysis 1 SDSP-002-04 TBD SDSP-002-05 ADaM SDSP-002-06 define.xml TBD MedDRA SDSP-002-07 (Adverse Events) SDSP-002-08 TBD SDSP-002-09 WHO-DD SDSP-002-10 (Medications) SDSP-002-19 TBD Planned ISE Relapsed or Refractory Ovarian or Breast ADaM v TBD / CDISC SDTM – ADaM IG TBD Terminology Cancer - Interim Analysis 1 SDSP-002-15 TBD ADaM define.xml TBD MedDRA (Adverse Events) TBD WHO-DD (Medications) TBD Non-Conformance to Supported Standards Justification Study Identifier Expected Standard Provided Standard Justification for Non-Conformance to Standards (including Exception Information)
SDSP-002-03 SDSP-002-04 SDSP-002-05 SDSP-002-06 SDSP-002-07 SDSP-002-08 SDSP-002-09 SDSP-002-10 SDSP-002-19 Planned ISS – Relapsed or Refractory Ovarian or Breast Cancer - Interim Analysis 1 ADaM v TBD / ADaM IG TBD ADaM define.xml TBD CDISC SDTM Terminology TBD MedDRA (Adverse Events) TBD WHO-DD (Medications) TBD SDSP-002-15 Planned ISE – Relapsed or Refractory Ovarian or Breast Cancer - Interim Analysis 1 ADaM v TBD / ADaM IG TBD ADaM define.xml TBD CDISC SDTM Terminology TBD MedDRA (Adverse Events) TBD WHO-DD (Medications) TBD Non-Conformance to Supported Standards Justification Study Identifier Expected Standard Provided Standard Justification for Non-Conformance to Standards (including Exception Information)
SDSP_Example_Oncology.docx