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Abstract

Working in conjunction with NCI has developed a collection of Standard Case Report Forms (CRFs) for use in developing new protocols. The project and its status are described here. The reuse of sections from standard CRFs helps to ensure that data collected in different studies is compatible and sharable. The metadata descriptions of these forms are in the caDSR Form Builder under the NCIP Context>Classifications>, and copies of each form have been exported and posted for downloaded on the NCI wiki.

Each standard CRF contains 3 sections:

  • Mandatory Questions
  • Optional Questions
  • Conditional Questions

The categories for which a standard CRF has been created are (click to download a Word version of this CRF):

  1. Adverse Events (AE) and Serious Adverse Events Version 3 (SAE)
  2. Adverse Events (AE) and Serious Adverse Events Version 4 (SAE)
  3. Appendix
  4. Base Intervention
  5. Concomitant Medications
  6. Consent
  7. Demography
  8. Diagnosis (Administrative)
  9. Diagnosis (Intervention)
  10. Drug Accountability Agents
  11. Eligibility
  12. End of Form
  13. Enrollment
  14. Equipment
  15. Footer
  16. Header
  17. Image Quality
  18. Laboratory Tests and Results
  19. Medical History
  20. Non-Agent Study Interventions (CURRENTLY ACTIVE)
  21. Off Study
  22. Off Treatment
  23. Outcome Measures
  24. Outcome Measures Glossary
  25. Participant Identifier
  26. Participants
  27. PET Emissions Scan
  28. PET Equipment QC Assessment
  29. PET Imaging Agent
  30. PET Patient Prep
  31. Physical Exam
  32. Prior and Post Therapy Agents
  33. Protocol Deviations
  34. Radiation Therapy
  35. Recommendations for Agent Vocabulary Naming and Coding
  36. Registration
  37. Screening
  38. Staging, Breast
  39. Staging, Cervix Uteri
  40. Staging, Colon and Rectum
  41. Staging, Corpus Uteri Carcinoma
  42. Staging, Corpus Uteri Sarcoma
  43. Staging, Fallopian Tube
  44. Staging, Gestational Trophoblastic Tumor
  45. Staging, Leukemia
  46. Staging, Liver
  47. Staging, Lymphoma
  48. Staging, Melanoma
  49. Staging, Myeloma
  50. Staging, Ovary
  51. Staging, Pancreas
  52. Staging, Prostate
  53. Staging, Soft Tissue Sarcoma
  54. Staging, Stomach
  55. Staging, Thyroid
  56. Staging, Urinary Bladder
  57. Staging, Vagina
  58. Staging, Vulva
  59. Study Agent Administration
  60. Surgery
  61. Survival
  62. Vital Signs

Cite this work

Researchers should cite this work as follows:

  • Denise Warzel; Ann Christine Catlin; Sumudinie fernando (2014), "NCI Standard CRFs," https://ncihub.org/resources/117.

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