Rationale
Vision
The Common Templates for Nonclinical Studies Initiative is pursuing, with input from sponsors, CROs and other stakeholders, the development of common templates for preclinical studies to improve efficiencies for investigators, sites, CROs, sponsors and regulators. Common templates will help minimize cost, errors, reduce burden for sites and CROs, and improve operational efficiencies during the interpretation and execution of studies. The initiative is focused on developing publicly available documents for preclinical study protocols and study reports that are intended to be used by CRO partners and sponsors.
Unmet Needs
CROs are often asked to adhere to a wide array of sponsor-specific protocol and/or report templates, often presenting information in different places and in different ways for each study. This has the potential to introduce errors, delays, increased workload, and an overall lack of consistency in study conduct and data quality.
Benefits
A common protocol template for preclinical studies will potentially:
- Decrease CRO and investigator time spent looking for key content
- Decrease study errors and improve data quality, with the potential to lead to reductions in animal usage due to fewer studies having to be repeated
- Lead to more rapid protocol development, allowing studies to get started more quickly
A common report template will potentially:
- Allow reports to be written more quickly – resulting in more rapid data delivery and speeding up development timelines
- Lead to the development of automation opportunities further improving efficiency and decreasing cycle times
Please see disclaimer below for additional information.
Nonclinical Common Protocol Template & Supporting Materials
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 (V1.1) 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.
Nonclinical Common Report Template & Supporting Materials
Common Report Template Project Objectives
BioCelerate developed a preclinical report template as a companion to the V1.1 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 Protocol 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 Health Authority review by having information presented in the same order and format
The V1.1 Nonclinical Common Report Template is based on the structure of the Nonclinical Common Protocol Template and stakeholder feedback. Feedback will continue to be key to robust and well-accepted Templates.
We invite all stakeholders to submit feedback via this form or 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.
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.