Standardized Case Report Form (CRF) Work Group
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.
The Standardized CRF Work Group is part of the Study Conduct Special Interest Group (SIG) and the Clinical Trials Management Systems (CTMS) Workspace.
Who should get involved?
The Standardized CRF Work Group encourages anyone who is interested and/or involved in the conduct, administration, and regulation of clinical trials. These include, clinical trialists, clinical investigators, research nurses, informaticists, clinical trial sponsors, IRB and FDA representatives. These and others are key stakeholders whose input, review and feedback is imperative to the successful development and deployment of applications to support clinical trials and enable improved exchange of clinical trial information.
Project Coordinator: Riki Ohira
NCI Lead: Dianne Reeves
Standardized CRF Work Group Participant Shortcuts