Guidance Document on Good In Vitro Method Practices (GIVIMP)
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible. Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions. GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.
Reporting of results
Key message: Good reporting of in vitro methods can only be achieved when all important details are recorded in a way that allows others to reproduce the work or reconstruct fully the in vitro method study.Key content: Guidance is given on publishing and reporting of in vitro method studies and on data reporting for regulatory purposes.Guidance for improved practice: Examples and available sources for scientific data management are detailed to promote more transparency and openness from scientists to avoid issues related to reproducibility of data but also to stimulate electronic data sharing for a variety of research and safety assessment purposes.Recommendations are given to not only publish or make available the in vitro method results but also all the related documents and the changes that have been introduced to improve the method and the rational for them.