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What is the Nonclinical Common Report Template?

BioCelerate is developing a nonclinical 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 Common Report Template

The goal of this NCRT 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

The Nonclinical Common Report Template V1.0, along with background and implementation materials (see links below), is now available for use. This companion document to BioCelerate’s Nonclinical Common Protocol Template is based on the structure of the NCPT and stakeholder feedback. We invite you to review the Template and Implementation materials and to share your feedback. Feedback will continue to be key to robust and well-accepted Templates.

We invite all stakeholders to submit feedback using the form below 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. We take your feedback seriously and greatly appreciate any and all responses.

Available Assets

TitleDescription
V1.0 Nonclinical Common Report TemplateA nonclinical report template for repeat-dose toxicology studies
Why Common Templates? Initiative OverviewProvides an overview and background of the nonclinical common protocol template project
Approaches to ImplementationA resource to support an organization’s efforts in determining if and how the organization will adopt the nonclinical protocol template


Disclaimer

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.