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Protocol Template Project Objectives

With input from key stakeholders, BioCelerate developed a toxicology study protocol template meant for first-in-human enabling, 28-day repeat dose studies. The purpose of a common template is to facilitate efficiencies for CROs, sponsors and others involved in toxicology study execution or review. This common template has the potential to enable process and create time efficiencies, reduce burden, minimize cost, and improve overall quality in the conduct of studies. Additionally, common templates across the study lifecycle can help promote end-to-end traceability and integrity of data, more streamlined study interpretation, and reuse of content.

Guiding Principles for the Nonclinical Common Protocol Template

Structure Must…
  • Make it easier for lab technicians to do their jobs
  • Order sections intentionally for easy reference and navigation
  • Enable process efficiency and quality execution / conduct
  • Minimize the need for major customizations
Content Must…
  • Use consistent terminology
  • Eliminate content better suited for inclusion in other documents
  • Align with OECD GLP guidance and eCTD format
  • Avoid process instructions where large variations in preferences exist

The Nonclinical Common Protocol Template (NCPT), along with background and implementation materials (see below), is now available for voluntary adoption. This version (V1.0) is based on feedback and comments which will continue to be key to a robust and well-accepted Template. We invite you to review the Template and Implementation materials, and to share your feedback as the team continues to work towards V2.0 which will be the second major release.

Feedback may be submitted using the Feedback Form on this page or share via email to info@biocelerate.org

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.

Available Assets

Title

Description

V1.0 Nonclinical Common Protocol Template A protocol template for FIH-enabling repeat-dose general toxicology studies available for voluntary adoption by sponsors and contract research organizations
Why an NCPT? Background & Executive Summary Provides an overview and background of the nonclinical common protocol template project
Approaches to Implementation in Your Organization A resource to support an organization’s efforts in determining if and how the organization will adopt the nonclinical protocol template
Mapping Tool An optional resource to assist an organization in assessing impact and facilitating adoption of the nonclinical protocol template
Mapping Tool Instructions Instructions and examples for completing the mapping exercise utilizing the optional Mapping Tool resource
FAQs Answers to Frequently Asked Questions regarding the nonclinical protocol template
BioCelerate Protocol Harmonization Initiative Poster A poster detailing BioCelerate’s objective in developing common templates for nonclinical studies and initial project to create a protocol template for FIH-enabling repeat-dose toxicology studies