Each instruction manual contains a list of CDEs for each of the CRF partitioned modules as well as annotations for the CDASH and/or SDTM mappings. The annotated CRFs contained within the instruction manual is only used to show CDISC mapping without consideration of the CRF layout.

• Adverse Events
  • CTCAEv4
  • CTCAEv5
• Concomitant Medication
• Consent
  • Consent
  • Consent Withdrawal
  • Consent Withdrawal QoL
  • Consent Withdrawal Specimen
• CT Image
  • CT Image Acquisition
  • CT Image Agent
• Demography
• Diagnosis
  • Diagnosis
  • Diagnosis Administrative
  • Diagnosis Intervention
• Eligibility
• End of Form
• Enrollment
• Equipment
• Footer
• Header
• Image
  • Image Administration
  • Image Quality
• Laboratory Tests and Results
• Lost to Follow-up
• Medical History
• Metastasis
• Off Study
• Off Treatment
• Participant Identifier
• Pathology
  • Gross Pathology
  • Microscopic Pathology
• Positron Emission Tomography (PET)
  • PET Emissions Scan
  • PET Equipment QC
  • PET Imaging Agent
  • PET Patient Preparation
• Physical Exam
• Prior/Post Therapies
• PRO-HRQoL Measures
  • Brief Pain Inventory (BPI) Short Form
  • EPIC-26
  • EQ-5D-3L
  • EQ-5D-5L
• Progression
• Protocol Deviations
• Radiation Therapy
• RECIST
  • iRECIST
  • irRC
  • irRECIST
  • RECISTv1.1
• Registration
• Response
• Screening
• Staging/Extent of Disease
  • AJCC 8th Edition, Breast
  • AJCC 8th Edition, Colorectal
  • AJCC 8th Edition, Lung
  • AJCC 8th Edition, Prostate
• Study Agent Administration
• Surgery
• Survival and Follow-up
• Vital Signs