June 18: DIA 43rd Annual Meeting in Atlanta, GA

Session Chair: Arthur Gertel Vice President of Clinical Services, Regulatory, and Medical Writing for Beardsworth Consulting Group, Inc., USA

The seminal document in the process of bringing products from molecule to medicine is the study protocol. From the viewpoint of the medical writer, it is the protocol that provides the critical information for use in preparing virtually all of the documents associated with a clinical research project.

HL7/CDISC have undertaken a multifaceted project to create common terminology, data structure, and protocol elements. The standardization and the ability to maintain consistency across sources of information will enhance the common understanding of terms, contribute to efficiency of information transfer, and provide an authoritative resource for training new members of the R&D community.

The panel will comprise members of the HL7/CDISC committees, representing the glossary, protocol development, BRIDG, PR, AdAM, and SDTM efforts. The current status of the glossary, protocol model, and the development of machine- and human-readable formats will be discussed.

For more information on the 43rd Annual DIA Conference visit the web site http://www.diahome.org/diahome/FlagshipMeetings/SearchSesTut.aspx?meetingid=11362