the prior U01? Table 8: Does “Operational Yes Efficiency Start Date” refer to a date estimated by the PI for the study to start? Table 8: Does “Number of It refers to the length of time from submission of the LOI to Days in Development” refer protocol activation, i.e. open to patient enrollment. to the length of time from submission of the LOI until protocol activation or some other time frame? Table 8: Does “Date of LOI Either the sponsor or institution. Please make sure you clearly Approval” refer to time of state whose approval you are referring to on the table. approval by the sponsor or institution? Table 8: Does “Date of First Yes Protocol Submission” refer to submission to the IRB? Table 8: Is this table supposed No, it can be for INDs held by pharmaceutical or federal to be only for studies in which government sponsors. the LAO, IC or AO hold the IND? Table 8: Does “Number of It refers to the date of LOI approval to date protocol is Days in Development” refer activated. Although we have generally used activation date, it to the length of time from is acceptable to use date first patient enrolled on study. The submission of the LOI until table column header should be clearly labeled and the analysis protocol activation or some consistently applied. other time frame? Table 8: We do not have LOI Based on the operations of your institution, use a date that is dates. Can we use another closest to the LOI / concept approval date. date, i.e., IRB approval or
the prior U01? Table 8: Does “Operational Efficiency Start Date” refer to a date estimated by the PI for the study to start? Yes Table 8: Does “Number of Days in Development” refer to the length of time from submission of the LOI until protocol activation or some other time frame? It refers to the length of time from submission of the LOI to protocol activation, i.e. open to patient enrollment. Table 8: Does “Date of LOI Approval” refer to time of approval by the sponsor or institution? Either the sponsor or institution. Please make sure you clearly state whose approval you are referring to on the table. Table 8: Does “Date of First Protocol Submission” refer to submission to the IRB? Yes Table 8: Is this table supposed to be only for studies in which the LAO, IC or AO hold the IND? No, it can be for INDs held by pharmaceutical or federal government sponsors. Table 8: Does “Number of Days in Development” refer to the length of time from submission of the LOI until protocol activation or some other time frame? It refers to the date of LOI approval to date protocol is activated. Although we have generally used activation date, it is acceptable to use date first patient enrolled on study. The table column header should be clearly labeled and the analysis consistently applied. Table 8: We do not have LOI dates. Can we use another date, i.e., IRB approval or Based on the operations of your institution, use a date that is closest to the LOI / concept approval date.