Advances in technology and science continue to contribute to the development of novel Substances of Human Origin (SoHO) and novel preparation protocols/processes for new and existing SoHO. It is important that the risks associated with these novelties are identified, quantified and assessed using a standard process. Any modification in the processes associated with the donation, collection, testing, processing, storage and distribution of SOHO may impact the quality of these therapies and therefore the safety of recipients. The EuroGTP II methodologies are specifically designed to evaluate risks to recipients, and not the risks to the donor arising from the collection process, for SoHOs donated by living individuals. However, it should be noted that in cases of autologous donation, the donor and recipient are the same individual.
The Euro GTP II Interactive Assessment Tool (IAT) has been developed to assist professionals involved in the provision of SoHO to:
• Determine if the SoHO preparation or process has any novelty (Step 1) • Assess the risks associated with the SoHO Preparation or its preparation process (Step 2) • • Determine the extent of any studies and/or follow up required to assure the safety and efficacy of the SoHO preparation/therapy. (Step 3)
It is essential that this process is performed by a group of individuals with the requisite knowledge to accurately identify and evaluate the risks detailed in the tool. Sufficient time and resource must be allocated to enable the process to be performed. This may involve detailed reviews of data and other literature to inform calculation of specific risks. The tool will generate a short summary report detailing the risks identified, and the risk scores, however the rationale for decisions, and evidence used to support them should be also recorded and retained.
