External validity is the extent to which research findings derived from in vitro models are useful for prediction of chemical substance’s potential to induce adverse health effects to humans. No single tool is obviously authoritative specifically for assessing the external validity of in vitro study designs. We aim to address this situation by developing a new tool for evaluating external validity of in vitro studies. We will build on prior work and use rigorous methods consistent with our intent to provide an authoritative assessment tool.

Expected deliveries:

Protocols

• Identification of external validity items
• Creation of the tool
• User testing

Creation of the tool

• External validity items
• Evaluation the relevance of the external validity items for in vitro studies
• Ranking external validity items according to importance for in vitro studies
• The draft tool
• The user testing and validation of the draft tool

The release version of the tool