The Executive Committee and Steering Committee agree that there will be equal involvement (MSGERC and ECMM) and transparency of all activities. There will be a consensus approach for methodology in evaluating current response criteria, taking an evidence approach, and shared collective experiences as investigators and as clinical trial Data Review Committee (DRC) and Data Safety Monitoring Board (DSMB). The groups are committed to diversity of committee and working group membership: geographic, gender and other criteria. The groups will include early career investigators but will rely on experienced clinicians to guide processes to bridge earlier criteria to current need. Each working group will include at least one patient representative at some stage of the process.  The groups will host listening sessions that will include investigators, patient representatives, industry, EMA, FDA and CDC.  In terms of industry involvement, the process will take a pan-industry approach and working group sessions will be closed (not including industry representatives) to ensure an unbiased approach. The groups will include outreach to regulatory authorities (FDA and EMA) in addition to inviting them to listening sessions. Working groups are encouraged to meet face-to-face; however, some meetings may take place using Zoom and E-mail exchanges. Some meetings may take place at larger international meetings and external funding from sponsors will be sought to help defray those costs. Committee and sub-group members agree that this is an activity that will not be compensating participants for the work of the committees and working groups and that the ECMM and MSGERC will share in-kind expenses.  The MSGERC Headquarters will lead the scheduling and travel arrangements for meetings and some of the expenses for this will come from funds raised.