Rationale

Vision

The Common Templates for Nonclinical Studies Initiative is pursuing the development of common templates for nonclinical studies in an effort to improve efficiencies for sponsors, CROs and other stakeholders. Common templates will help minimize cost, errors, and improve operational efficiencies during the interpretation and execution of studies. The initiative will develop 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 required 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

Protocol Template Version 0.1 for Repeat-Dose Toxicology Studies is now available for public comment. Click below to access the template and leave feedback.
Nonclinical Protocol Template

Events

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