GAPP-PRO D8.2 Update of the EUROGTP II Interactive Assessment Tool

The EuroGTP II Interactive Assessment Tool – Other Substances of Human Origin is a simple web page, available at https://tool.goodtissuepractices.site/staging/indexS.html, on which a set of specific steps collect several inputs from users, through multiple sections and subsections. When all inputs have been provided it computes them, applies the algorithm defined by EuroGTP II, and displays the calculated results.

Using the IAT, and after the user has agreed to the presented disclaimer, the Substance of Human Origin (SoHO) must be defined. The tool includes human milk, blood components for topical use or injection and intestinal microbiota. Based on type of SoHO and the information provided on step 1, the tool determines if this SoHO/therapy/process introduces novelty, and if so, the tool moves to step 2. Otherwise, the assessment is terminated as no novelty has been identified. On step 2 individual risk factors are analyzed and user shall introduce details for each applicable risk consequences. The set of risks factors and risk consequences presented is based on the SoHO initially defined by the user. Once all information has been collected, the IAT presents a report, which includes all data introduced in the risk assessment. This report presents also the summary of “extent of studies proposed according the level of risk” and the links for the “risk reduction strategies” and the “clinical evaluation” proposed in the EuroGTP II/Other Substances of Human Origin Specific Chapter.