Page History
Section | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Module Status Table
CRF Modules | Round of Harmonization & Standardization | Current Status of Module | |||||||
---|---|---|---|---|---|---|---|---|---|
2 | Internal Harmonization complete; Expanded Committee Review scheduled for March 2010. | ||||||||
3 | Internal Harmonization complete; Expanded Committee Review will follow Round 2. | ||||||||
3 | Internal Harmonization complete; Expanded Committee Review will follow Round 2. | ||||||||
3 | Internal Harmonization complete; Expanded Committee Review will follow Round 2. | ||||||||
4 | Internal Harmonization complete; Expanded Committee Review will follow Round 3. | ||||||||
1 | Harmonization complete; Approved as standard on 10/30/09 | ||||||||
4 | Internal Harmonization complete; Expanded Committee Review will follow Round 3. | ||||||||
3 | Internal Harmonization complete; Expanded Committee Review will follow Round 2. | ||||||||
4 | Internal Harmonization complete; Expanded Committee Review will follow Round 3. | ||||||||
2 | Internal Harmonization complete; Expanded Committee Review scheduled for March 2010. | ||||||||
4 | Internal Harmonization complete; Expanded Committee Review will follow Round 3. | ||||||||
4 | Internal Harmonization currently underway. | ||||||||
3 | Internal Harmonization complete; Expanded Committee Review will follow Round 2. | ||||||||
2 | Internal Harmonization complete; Expanded Committee Review scheduled for March 2010. | ||||||||
4 | Internal Harmonization complete; Expanded Committee Review will follow Round 3. | ||||||||
4 | Internal Harmonization complete; Expanded Committee Review will follow Round 3. | ||||||||
3 | Internal Harmonization complete; Expanded Committee Review will follow Round 2. | ||||||||
3 | Internal Harmonization complete; Expanded Committee Review will follow Round 2. | ||||||||
2 | Internal Harmonization complete; Expanded Committee Review scheduled for March 2010. | ||||||||
2 | Internal Harmonization complete; Expanded Committee Review scheduled for March 2010. | ||||||||
3 | Internal Harmonization complete; Expanded Committee Review will follow Round 2. | ||||||||
2 | Internal Harmonization complete; Expanded Committee Review scheduled for March 2010. | ||||||||
2 | Internal Harmonization complete; Expanded Committee Review scheduled for March 2010. | ||||||||
4 | Internal Harmonization complete; Expanded Committee Review will follow Round 3. | ||||||||
3 | Internal Harmonization complete; Expanded Committee Review will follow Round 2. | ||||||||
4 | Internal Harmonization complete; Expanded Committee Review will follow Round 3. |
|
Introduction
The Standardized Case Report Form (CRF) Work Group is focused on establishing a core library of harmonized and standardized Phase II and III CRFs and data collection modules through stakeholder consensus. A core library of harmonized and standardized CRFs will be highly valuable to the cancer clinical trials community because it will provide a standardized mechanism for comparing and aggregating information across the NCI's clinical trial portfolio. Additionally, a harmonized CRF library will improve the efficiency and accuracy of the routine review of safety, efficacy, and administrative data from ongoing NCI-funded clinical trials. Finally, by reducing the time spent in developing a data collection strategy per trial, this core library will allow for faster initiation of new trials; thus, speeding the process of delivering new and improved treatments to patients.
...