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):
- Adverse Events (AE) and Serious Adverse Events Version 3 (SAE)
- Adverse Events (AE) and Serious Adverse Events Version 4 (SAE)
- Appendix
- Base Intervention
- Concomitant Medications
- Consent
- Demography
- Diagnosis (Administrative)
- Diagnosis (Intervention)
- Drug Accountability Agents
- Eligibility
- End of Form
- Enrollment
- Equipment
- Footer
- Header
- Image Quality
- Laboratory Tests and Results
- Medical History
- Non-Agent Study Interventions (CURRENTLY ACTIVE)
- Off Study
- Off Treatment
- Outcome Measures
- Outcome Measures Glossary
- Participant Identifier
- Participants
- PET Emissions Scan
- PET Equipment QC Assessment
- PET Imaging Agent
- PET Patient Prep
- Physical Exam
- Prior and Post Therapy Agents
- Protocol Deviations
- Radiation Therapy
- Recommendations for Agent Vocabulary Naming and Coding
- Registration
- Screening
- Staging, Breast
- Staging, Cervix Uteri
- Staging, Colon and Rectum
- Staging, Corpus Uteri Carcinoma
- Staging, Corpus Uteri Sarcoma
- Staging, Fallopian Tube
- Staging, Gestational Trophoblastic Tumor
- Staging, Leukemia
- Staging, Liver
- Staging, Lymphoma
- Staging, Melanoma
- Staging, Myeloma
- Staging, Ovary
- Staging, Pancreas
- Staging, Prostate
- Staging, Soft Tissue Sarcoma
- Staging, Stomach
- Staging, Thyroid
- Staging, Urinary Bladder
- Staging, Vagina
- Staging, Vulva
- Study Agent Administration
- Surgery
- Survival
- Vital Signs
Researchers should cite this work as follows: