Advances in technology and science continue to contribute to the development of novel Tissue and Cellular Therapies/Products (TCTPs) and novel preparation protocols for new and existing TCTPs. 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, procurement, testing, processing, storage and distribution of TCTPs may impact the quality of these therapies/products and therefore the safety of donors or recipients.
The Euro GTP II Interactive Assessment Tool (IAT) has been developed to assist professionals involved in the provision of TCTPs to:
• Determine if a TCTP or process has any novelty (Step 1) • Assessment of the risks associated with the TCTP or process (Step 2) • Determine the extent of any studies and/or follow up required to assure the safety and efficacy of TCTPs. (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.
