PhUSE is an independent, non-profit consortium of academic, regulatory, non-profit, and private sector entities. The organization “provides a global platform for the discussion of topics encompassing the work of biostatisticians, data managers, statistical programmers, and e-clinical information technology professionals, with the mission of providing an open, transparent, and collaborative forum to address computational science issues.” FDA is a member of PhUSE.
In order to help its members, PhUSE will sometimes publish proposals that are intended to enhance the review and analysis of certain data that is submitted to regulatory agencies.
Nonclinical SDRG Template
In December 2014, the FDA published the first version of its Study Data Technical Conformance Guide. The guide includes a number of recommendations associated with “the submission of animal and human study data and related information in a standardized electronic format.” Furthermore, the FDA recommends that a Study Data Reviewer’s Guide be submitted with each study. The review’s guide is intended to facilitate the review of the study data by drawing attention to any special considerations or instructions.
In its guide, FDA draws attention to the PhUSE SDRG template, stating that it is a good example of how to create a SDRG; however, the Agency conversely does not recommend its use. As such, the Agency is now planning to review the PhUSE template to determine whether the FDA will recommend its use as is, in a modified form, or not at all for regulatory submissions of nonclinical study data.
Good Review Management Principles & Practices, Part Two: Operational Principles
Details on the fundamental values outlined on FDA’s GRMP draft guidance are available in our preceding article, entitled “Good Review Management Principles & Practices, Part One: Fundamental Values"...