Table 5.

Common components of an IST protocol (IATA = Integrated Approaches to Testing and Assessment; AOP = Adverse Outcome Pathways)

Introduction	Describe the major toxicological endpoint being assessed Outline the general hazard assessment framework, including how a series of toxicological effects or mechanisms are related to one or more endpoints Provide citations to any applicable AOPs or IATAs used
In silico methodologies and models	Identify toxicological effects or mechanisms that might realistically be predicted Define what in silico methodologies are appropriate to use Specify additional considerations as to what constitutes an acceptable model Discuss issues to be considered as part of any read-across analysis
Experimental data	Define specific study types and result(s) relevant to each toxicological effect or mechanism Define and justify the relevance of the information to the assessment of the toxicological endpoint (defined in the hazard assessment framework) Define specific factors to consider when assessing the results and documenting the reliability of any available data or reference specific test guideline(s) Identify sources of data that may be considered
Toxicological effects or mechanisms assessment and reliability scores	Describe how each toxicological effect or mechanism assessment may be generated from available experimental data and/or in silico prediction(s) Define additional items to consider as part of an expert review Discuss any endpoint specific issues to consider as part of the reliability score
Toxicological endpoint assessment and confidence	Describe the toxicological endpoints that will be used as part of the hazard assessment framework Describe the rules or principles for determining each endpoint assessment, based on the associated effect/mechanisms or other endpoints Define the rules or principles for determining each toxicological endpoint confidence, based on the relevance and reliability (from associated effects/mechanisms) or confidence (from associated endpoints) Identify points to consider as part of any expert review
Reporting	Define a format for a report of the results, expert review and conclusions
Other considerations	Case studies