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 nonclinical studies in an effort 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 open-source documents for nonclinical 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 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

Available Assets

How You Can Get Involved

Version 1.0 of the Protocol Template for Repeat-Dose Toxicology Studies is now available for voluntary adoption by the public. Version 1.0 incorporates member company input and several rounds of stakeholder feedback provided on the previous working drafts, Version 0.1 and Version 0.2. As feedback and comments are key to a robust and well-accepted Template, we invite all stakeholders to continue to submit feedback and comments regarding adoption and improvements for a future version.

Nonclinical Protocol Template

Disclaimer

Events

In case you missed it, check out the recordings from our recent webinar, “Protocol Template for Repeat-Dose Toxicology Studies.”