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.
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
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 firstname.lastname@example.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.
These materials are provided ‘AS IS’ WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. BioCelerate and its members do not accept any responsibility for any loss of any kind including loss of revenue, business, anticipated savings or profits, loss of goodwill or data, or for any indirect consequential loss whatsoever to any person using these materials or acting or refraining from action as a result of the information contained in these materials. Any party using these materials bears sole and complete responsibility for ensuring that the materials, whether modified or not, are suitable for the particular use and are accurate, current, commercially reasonable under the circumstances, and comply with all applicable laws and regulations. Nothing in these documents should be construed to represent or warrant that persons using these documents have complied with all applicable laws and regulations. All individuals and organizations using these documents bear responsibility for complying with the applicable laws and regulations for the relevant jurisdiction.