ABSTRACT The JHU SSRC is an established, functioning team of multisite trial PIs, experienced lead managers, administrators, and scientists. BIOS, a JHU Clinical Trials Coordinating Center, will operationally convene this group and provide staff to execute the required Statistical and Safety Resource Center program and its specific assigned tasks in the areas of statistics, safety, and DSMB management. Our joint expertise, developing and managing trials in these specified areas extends well beyond the last five years of work on the ongoing HEAL Pain ERN studies with our group having served as clinical coordinating centers and data coordinating centers for dozens of large multi-centered clinical trials at various NIH ICs. We seek to continue our support of the awardee teams for an extended duration not originally budgeted and planned for due to the enrollment delays in POSITIVE, SKOAP, and SurgeryPal trials.

NARRATIVE The NIH has created the Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. Trials will be conducted through the NIH HEAL Pain Management Effectiveness Research Network (HEAL Pain ERN), which will use the infrastructure of the NCATS Trial Innovation Network to provide scientific guidance and coordination of the HEAL Pain ERN Trials. The four resource centers will provide integrated functions for the clinical coordinating resource center, data coordinating resource center, statistics and safety resource center, and recruitment resource center with Johns Hopkins serving as the Statistics and Safety Resource Center.