Kit Howard

CDISC's clinical data standards are widely used for clinical research, but many people wonder why there seem to be two standards for collected data, the Clinical Data Acquisition Standards Harmonization (CDASH) standard and the Study Data Tabulation Model (SDTM) standard. This poster steps through four significant reasons that reflect their differences in philosophy, intermediate goals and broad-scale uses. Examples illustrate each reason and how they affect your studies.

This poster… Show more

CDISC's clinical data standards are widely used for clinical research, but many people wonder why there seem to be two standards for collected data, the Clinical Data Acquisition Standards Harmonization (CDASH) standard and the Study Data Tabulation Model (SDTM) standard. This poster steps through four significant reasons that reflect their differences in philosophy, intermediate goals and broad-scale uses. Examples illustrate each reason and how they affect your studies.

This poster contains a subset of differences that were originally included in a presentation developed by Kit Howard and Shannon Labout for a CDISC Interchange. Show less

On October 25, 2012, the FDA made a clear statement at the annual CDISC Interchange in Baltimore, Maryland that electronic standards such as those developed by CDISC will be required. This has particular implications for medical device submissions due to the lack of familiarity with CDISC standards by sponsors and the FDA. While the FDA does accept SDTM domains for medical device submissions, there is currently no consistent data standards and/or requirements for medical device submissions… Show more

On October 25, 2012, the FDA made a clear statement at the annual CDISC Interchange in Baltimore, Maryland that electronic standards such as those developed by CDISC will be required. This has particular implications for medical device submissions due to the lack of familiarity with CDISC standards by sponsors and the FDA. While the FDA does accept SDTM domains for medical device submissions, there is currently no consistent data standards and/or requirements for medical device submissions. CDRH is required to develop standards for submissions and the work of the Device Team will be important in developing these standards. The Device Team (in cooperation with the FDA) has developed seven new SDTM domains. However, much work remains to define the standards for submission of medical device data in an electronic format. To that end a CDISC pilot with CDRH is planned. This paper will focus on the challenges for sponsors and the FDA in defining these standards. Show less

Are clinical trials data “fit for use”? It depends upon how we want to use them.
•To answer this, we must know the rules used to define, capture, database, clean, report and analyze them, including (in)consistencies in business rules among sites, studies, and submissions.
•Data fit for use within a study may be unfit when aggregated with other studies.
•Rules are documented but are often unavailable to those using the data, especially later in the process

The poster presents a… Show more

Are clinical trials data “fit for use”? It depends upon how we want to use them.
•To answer this, we must know the rules used to define, capture, database, clean, report and analyze them, including (in)consistencies in business rules among sites, studies, and submissions.
•Data fit for use within a study may be unfit when aggregated with other studies.
•Rules are documented but are often unavailable to those using the data, especially later in the process

The poster presents a number of examples showing how data from studies on the same compound using the same protocol can become incomparable when operational data quality rules are not defined consistently. The biggest concern is that, today, there is no way to know this. Show less