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The CRF Harmonization and Standardization Initiative was launched in = 2006 based on recommendations from the Clinical Trials Working Group (CTWG) report of 2005. The CTW= G recommended developing standardized Case Report Forms incorporating Commo= n Data Elements to improve information sharing among cancer researchers and= optimize data requirements in collaboration with the Federal Drug Administ= ration (FDA). A harmonized CRF library will improve the efficiency an= d accuracy of the routine review of safety, efficacy, and administrative da= ta from ongoing NCI-funded clinical trials. Finally, by reducing the time s= pent 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 was originally part of the Study Conduct= Special Interest Group (SIG) and the Clinical Trials Management Systems (C= TMS) Workspace.
To begin the CRF work, a road map was created that has evolved over time= to reflect the progress made by the community. The prioritization st= arted by choosing one module that could be a proof of concept or a test of = process for a way the work group could be structured. The first modul= e chosen was the Demography module. As the team worked through this m= odule defining structures, group rules, interactions, and best practices th= ey begin to move forward on areas of content such as Adverse Events and Enr= ollment. The leads for each of the working groups remained the same f= or consistency. The road map continues to evolve and will be complete= d when a set of elements have been identified to reflect the core data coll= ection and analysis points for a clinical trial.