is being presented by Jonathan Andrus & Jennifer Price, Vice President, Data Management and Quality & Director, Clinical Solutions, of BioClinica and airs on Tuesday, March 8th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In 2010 the FDA released its draft standards plan ‘CDER Data Standards Plan Version 1.0’ which outlines key objectives for a data standards program at CDER. The use of standards in clinical research is evolving and gaining widespread acceptance. This presentation reviews the standards listed in the FDA’s draft plan, along with others relevant to clinical research.
Standards can be used from the beginning of the clinical research process starting with protocol design, moving to data collection, data analysis, and data submission. Standards are also used by disparate systems for the exchange of data. By using standards, your company can design standard data collection and reporting structures and libraries. When using standard libraries, functions such as training and programming can be streamlined to increase efficiencies and reduce rework.
This presentation provides attendees with a general understanding of the current and emerging standards being used today in our industry – including PRM, CDASH, SDTM, ODM, AdAM, LAB, CDISC Terminology, eCTD, HL7, RFD and BRIDG – and how each standard relates to specific job functions.
