Page History

Each instruction manual contains a list of CDEs for each of the CRF partitioned modules CDE field descriptions with format instructions, CDISC mapping information, 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 

Click on the link below to open document, then click on the download icon in the top right corner to access the PDF file.

• 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