CSS Working Group initiates best practices document with recommendation for Data Sizing
Silver Spring (MD), November 2013
The SDTM Validation Rules Project in the FDA/PhUSE CSS Data Quality Working Group has initiated this Best Practices document to address the following challenge faced by industry when implementing CDISC SDTM models.
The project team will be collecting feedback on this document through the end of 2013.
Check Data Sizing Best Practices Recommendation for more details.
About the CSS
The Annual Computational Science Symposium (CSS) brings together Academia, Regulators, Industry and technology providers to address computational science needs in support of regulatory review and ultimately bring safe and effective products to those who need them.
The focus of the CSS is to continue the work initiated at the previous annual meetings by bringing FDA, industry and academia together to provide an update on current initiatives ongoing within the FDA, explore emerging technologies and establish collaborative working groups to address current challenges related to the access and review of data to support product development. Previous work has included the creation of a Study Data Reviewer's Guide Template for submission, development of a non-clinical road map and the application of semantics technology to standards.
For more details on the CSS see here
PhUSE, Share – Contribute – Advance, provides the industry with the premier platform for creating and sharing ideas, tools and standards around data, statistical and reporting technologies; PhUSE is a non-profit, volunteer-supported, community of professionals who are passionate about advancement of clinical information. Since its inception, PhUSE has expanded from its roots as a conference for European Statistical Programmers, to a global platform for the discussion of topics encompassing the work of Data Managers, Biostatisticians, Statistical Programmers and eClinical IT professionals.