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What is the Nonclinical Study Report Template?

BioCelerate is developing a nonclinical study report template as a companion to the currently available V1.0 Nonclinical Common Protocol Template for the purpose of supporting consistency and efficiencies in the report generation process and reduce the burden on sites, CROs, and sponsors.


Guiding Principles for the Nonclinical Study Report Template

The goal of this NSRT is to:
  • Reduce cycle times
  • Simplify the report generation process for study directors at both Sponsor and CRO organizations
  • Reduce quality assurance/quality control using hyperlinks to contributor reports
  • Facilitate Regulatory review by having information presented in the same order and format

Available Assets

How to Get Involved

Version 0.1 of the Nonclinical Study Report Template (NSRT), a companion template to BioCelerate’s V1.0 Nonclinical Common Protocol Template, is now available for review and feedback by the public. It is a working draft document based on the structure of the NCPT V1.0 and stakeholder feedback. As feedback and comments are key to a robust and well-accepted Nonclinical Study Report template, we invite all stakeholders to review and submit feedback on Version 0.1 using the form below to improve the NSRT for its first release. Feedback may be submitted using the form on this page or you may also provide more detailed, section-specific feedback offline by downloading the detailed feedback Excel spreadsheet and emailing the completed form to info@biocelerate.org. Let us know your thoughts on the project and/or any specific pieces of the template. We take your feedback seriously and greatly appreciate any and all responses.


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