(97) Key Elements and Challenges in Activating Clinical Centers for the NIH-Funded CORD-CHD Multisite Trial

Background: Accomplishing timely study activation, site launch, and recruitment under competitive NIH milestones, sIRB mandates, and multidisciplinary collaboration is challenging. The CORD-CHD trial involves multiple clinical centers across the US and Canada, requiring effective management of activation tasks for long-term success.

Objectives: To describe unique elements of clinical center activation and impacts on enrollment milestones when launching the NHLBI-funded CORD-CHD trial, a pragmatic multisite randomized trial (NCT06153459).

Design/Methods: Prenatal Consent using Locked Consent + Site Specific Amendment: The trial used a study-wide locked consent and site-specific addenda to streamline local IRB review. This was accepted by most sites, with five of 18 requiring specific exceptions.
sIRB through IREx: NIH mandates the single-IRB (sIRB) mechanism for all US sites. Reliance agreement activities were managed through IREx for the 18 US clinical centers. Six of 21 sites (29%) required multiple reliance agreements for birthing and treatment hospitals.
Subawards: The CORD-CHD trial is funded through a U-Grant mechanism, with the first year having a different Federal Award Identification Number from subsequent years. This caused re-collection of documents after the first year and delayed second-year amendments.
Study Staff Engagement: Training and regulatory document completion can be time-consuming, especially for clinical providers not largely engaged in research. Obstetrical providers and delivery room staff were not considered engaged in the study for performing cord clamping, completing a delivery room source document, and opening a randomization envelope, minimizing their training burden.

Results: 17 of 21 sites across two countries completed study launch activities in the first two years of CORD-CHD funding (4/1/23-4/1/25). Four sites were delayed due to budget constraints from surpassed recruitment milestones. Of the 17 activated sites, 11 US sites (52%) began screening in the first funding year and six (29%) in the second year (five US sites, one Canadian site). CORD-CHD consented the first subject in December 2023 and randomized the first subject in April 2024. A total of 165 participant dyads were consented and 126 dyads

Conclusions: N/A