Analysis Data Reviewers Guide (ADRG) finalized
Silver Spring (MD), 14May2014
The Analysis Data Reviewer's Guide (ADRG) is finalized. This is a major deliverable of the PhUSE CSS working group "Optimizing the Use of Data Standards" where members of the pharmaceutical industry, CDISC and FDA closely collaborate.
CDISC ADaM provides a framework that enables analysis of the data, while at the same time allowing reviewers and other recipients of the data to have a clear understanding of the data’s lineage from collection to analysis to results. Although ADaM provides a robust metadata framework, FDA Reviewers benefit from additional, human-readable, documentation of analysis methods, data sets, and programs that cannot be fully explained within the ADaM metadata.
The ADRG package contains a template to be used in submissions with completion guidelines and examples to help sponsors with their implementation. It provides an orientation to the submitted data in a consistent and usable format.
Check [ADRG package v1.0] 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.