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
- Concomitant Medication
- Consent
- CT Image
- Demography
- Diagnosis
- Eligibility
- End of Form
- Enrollment
- Equipment
- Footer
- Header
- Image
- Laboratory Tests and Results
- Lost to Follow-up
- Medical History
- Metastasis
- Off Study
- Off Treatment
- Participant Identifier
- Pathology
- Positron Emission Tomography (PET)
- Physical Exam
- Prior/Post Therapies
- PRO-HRQoL Measures
- 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