HEAL Sickle Cell and CDE Supplement

Abstract The NIH has created the Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. As part of the HEAL initiative, RFA-AT-23-002 HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative

Agreement (UG3/UH3, Clinical Trial Required) was posted; and it is anticipated that two awards will be selected to conduct trials through the NIH HEAL Pain Management Effectiveness Research Network (ERN). The two trials will be managed by different mechanisms. The first trial (herein referred to as the primary trial) will be managed

similarly to the five ongoing HEAL ERN trials. The three HEAL ERN resource centers will function as an integrated infrastructure to provide clinical coordinating center (CCC) support (Duke/Vanderbilt), data coordinating center (DCC) support (Utah), and biostatistics support (Hopkins/Tufts). The second trial (herein referred to as the

secondary trial) will be managed by the University of Utah for both CCC and DCC support. For both trials Utah will provide single institutional review board (sIRB) services. In addition to the Sickle Cell trials, this supplement also covers Utah support for the HEAL Common Data Elements (CDE) Program for one year. Efforts to date

on the CDE Program focused on the pain arm of HEAL, led by the National Institute of Neurological Disorders and Stroke (NINDS). The National Institute on Drug Abuse (NIDA) leads the Opioid arm, which is beginning CDE efforts. This CDE supplement request covers work to be performed by the HEAL CDE team at the University

of Utah, and supports three main activities: (1) CDE document preparation (NINDS), (2) HEAL CDE program administrative operations (NINDS), and (3) Survey of instruments used by OUD studies (NIDA). The University of Utah HEAL ERN Resource Center is requesting an administrative supplement to enable support of the NIH

HEAL initiative as described above. The supplement will support the following specific aims: Specific Aim 1. Provide data coordinating center support for the primary sickle cell trial, working with the other ERN Resource Centers in the same manner as the current five ERN trials, as detailed in the parent grant.

Specific Aim 2. Provide comprehensive clinical and coordinating center support for the secondary sickle cell trial. Specific Aim 3. Support the HEAL CDE Project through (1) CDE document preparation, (2) HEAL CDE program administrative operations, and (3) survey of instruments used for OUD studies.