C3D BTTC eCRFs Instructions Manual


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At the end of 2003, the National Cancer Institute's Center for Cancer Research (CCR) developed and started using the Cancer Central Clinical Database (C3D) - a client-server computer system - to capture data for oncology clinical trials research trials conducted at the CCR.

This manual was developed for data managers and study coordinators responsible for capturing patient data from BTTC clinical trials into C3D. It contains general instructions on how to complete the Standard Case Report Forms (eCRF) developed for BTTC trials, such as time frames for data entry. It also includes specific details on how to complete each eCRF, defining the required fields, pick lists available and validations to assist with data entry.

If you have questions or comments, please forward your feedback on this manual to the NCI Brain Tumor Trials Collaborative.

General Instructions for completion of all Case Report Forms


BTTC Adverse Events

BTTC Baseline Disease Assessment

BTTC Baseline Medical History

BTTC Baseline Symptoms

BTTC Concomitant Measures and Medications

BTTC Course Assessment

BTTC Course Initiation

BTTC Eligibility Checklist

BTTC Enrollment

BTTC Extent of Disease

BTTC Follow up



BTTC MDASI-Simplified


BTTC Neurological Assessment

BTTC Off Study

BTTC Off Treatment

BTTC Overall Survival

BTTC Physical Exams - Courses

BTTC Physical Exams - Screening

BTTC Physical Exams - Simplified

BTTC Post Treatment Medication

BTTC Prior Radiation Supplement

BTTC Prior Surgery Supplement

BTTC Prior Therapy Supplement

BTTC Prior Treatment Summary

BTTC Procedures

BTTC Seizure Activity Summary

BTTC Specimen Status

BTTC Study Medication Administration

Appendix III - Lab Panels