Status
As of June 2024, the BioCelerate Nonclinical Common Templates (NCT) Initiative team had fulfilled all program objectives and published two key assets and accompanying resources. These publicly available materials remain available for voluntary use/implementation by sponsors, CROs and other interested stakeholders. No new deliverables are planned.
Rationale
The BioCelerate team developed common templates for preclinical studies to enhance efficiency for investigators, sites, CROs, sponsors and regulators. CROs were particularly affected by the lack of common templates, often grappling with a wide array of sponsor-specific protocol and/or report templates which organized information in different places and ways for each study.
The team understood that the development of a common template could help to achieve the following in a short period of time:
- reduce errors
- lessen the burden on sites and CROs
- boost overall operational efficiency
Furthermore, the team recognized that use of a common template could support three longer-term aims:
- faster protocol development and report writing, allowing studies to begin – and advance – more quickly
- improved consistency in study conduct and data quality, enabling reduced animal usage due to fewer studies having to be repeated
- development of automation opportunities to generate incremental efficiencies and decrease cycle times
Process
Efforts focused on developing templates for preclinical study protocols and reports. The team sought regular input from key industry stakeholders – including sponsors and CROs – to develop effective templates and guidance.
The team developed a toxicology study protocol template meant for first-in-human enabling, 28-day repeat dose studies. The intention behind this template was to make it easier for lab technicians to do their jobs by streamlining the ordering of the sections, using consistent terminology, eliminating non-core content, aligning with OECD GLP guidance and eCTD format, and avoiding process instructions where large variations in preferences existed.
Similarly, the creation of the nonclinical report template was aimed at improving efficiency across multiple stakeholder groups by reducing cycle times, simplifying report generation, improving quality control via hyperlinks to contributor reports, and better enabling health authority review.
Solutions
Nonclinical Common Protocol Template
This template is now available for voluntary adoption. Access the full toolset – including background and implementation materials – here.
Nonclinical Common Report Template
Developed as a companion to the nonclinical common protocol template, the report template is also now available for voluntary adoption. Access the full toolset – including background and implementation materials – here.
Feedback and Impact
Have any feedback on these resources or experiences to share regarding implementation? Please use our feedback form.
All BioCelerate and TransCelerate initiatives are geared towards providing practical solutions to reduce inefficiencies in clinical trials, nonclinical studies, and drug safety. Learn about other BioCelerate and TransCelerate initiatives and solutions.
Disclaimer
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