FDA to Review PhUSE Nonclinical Study Data Reviewer’s Guide Template

March 9, 2016

As a part of its ongoing collaboration with the Pharmaceutical Users Software Exchange (PhUSE), the FDA has announced its plans to review the proposed Nonclinical Study Data Reviewer’s Guide (SDRG) template.

What is PhUSE?

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.

FDA is seeking public feedback on all matters regarding the use of the PhUSE Nonclinical SDRG template, and is asking interested parties to submit comments in electronic or written format no later than Tuesday, May 3rd.

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