Silver Spring, MD (PRWEB) May 16, 2014
PhUSE announces the availability of the Analysis Data Reviewer’s Guide (ADRG) package. The package contains templates, instructions, and examples to be used in submissions. Although CDISC ADaM provides a robust metadata framework, FDA Reviewers benefit from additional, human-readable, documentation. Along with the define.xml the ADRG provides an orientation to the submitted analysis data in a consistent and usable format. The ADRG Work Package includes an ADRG Template, ADRG Template Completion Instructions, and example ADRGs including an example from the CDISC SDTM/ADaM Pilot. It is available at the following link: http://bit.ly/1jI4tCz
The development and adoption of data standards over the last decade has shown significant promise in improving efficient delivery of data to support drug product and device submissions as well as the review process. However, there have also been gaps, issues and challenges in the interpretation and use of data standards. The PhUSE CSS working group "Optimizing the Use of Data Standards" identifies specific gaps that prevent FDA and industry from optimizing the use of data standards.
After the finalization of the SDRG last year, the finalization of the ADRG marks another major milestone of this working group and closes another critical gap.
James Johnson, PhD (Summit Analytical) Industry Co-lead of the Optimizing Data Standards working group is excited about the finalization of the ADRG package. Johnson said, "The release of the Analysis Data Reviewer's Guide (ADRG) package on 2014-05-13, as well as the SDRG package (2013-05-13), provides a complete tool set for industry to submit "Reviewer's Guides" with standardized SDTM and ADaM data with submissions to regulatory authorities. This ADRG package is a great example of a joint collaborative effort across the industry and regulatory environment to deliver a common standard based on experience and best practice".
The ADRG was created out of a close collaboration of members of the pharmaceutical industry, CDISC and FDA which was initiated through PhUSE during the PhUSE Computational Science Symposium (CSS). The ADRG core team was led by Susan Kenny (Amgen), Gail Stoner (J&J) and Mina Hohlen (FDA).
The complete ADRG package can be found here: http://bit.ly/1jI4tCz
The complete SDRG package can be found here: http://bit.ly/1lzmYs5
An entire catalog of the PhUSE CSS deliverables can be found here: http://www.phuse.eu/CSS-deliverables.aspx.
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, Clinical Data Scientists and eClinical IT professionals.