...

The Round 4 modules: Header Information, Imaging/Radiology, Non-agent Study Interventions, Diagnosis/Pathology, Vital Signs, Eligibility Criteria, and Off Treatment/Off Study are in harmonization progress via the CRF Workgroups.  They are scheduled to finish by early November 2009.

Metrics

The CRF Harmonization & Standardization project was initiated to provide a harmonized and standardized set of variables to be collected for oncology clinical trials that could be implemented to facilitate data entry, and study aggregation, comparison and analysis. The CRF collection process for Rounds 1-3 only collected Case Report Forms specific for that module. However, prior to Round 4, the Workgroup Leads recommended collecting CRFs for all areas and doing a single CRF inventory for all remaining modules, current and future Rounds.

The general metrics from the Round 4 CRF Inventory include:

17 Contributing Organizations
Contributing Organizations: CCR, DCP, University of Pennsylvania, CDASH, NCCTG, CTMS Theradex, CIP (FIMSO), UCSD, CALGB, COH, ACOSOG, Duke, ACRIN, ECOG, University of Michigan, Baylor College of Medicine, and RTOG
237 Case Report Forms
7697 variables (total)
More metrics on the CRFs, variables and modules will be posted on this page.

CRF Project Wiki Child Pages