Register studies with clinicaltrials.gov

All researchers conducting investigator-initiated studies are required to register and report results of clinical trials at clinicaltrials.gov, a publicly-accessible registry. Registration is required to promote responsible dissemination of information about clinical trials to the public, ensure compliance with pertinent federal and state law and funding agency requirements and meet professional publication standards. Most journals will not accept manuscripts reporting results from clinical studies that are not posted on clinicaltrials.gov. For industry-sponsored trials, the sponsor is responsible for providing this information for the web site.

Le Bonheur has designated Kerry Moore, CFRI manager of Compliance and Regulatory Affairs, as the administrator for the Le Bonheur’s Protocol Registration System (PRS) account. CFRI will provide assistance with determining if a study is an applicable clinical trial, account set up or password reset, registration of trials and results reporting. It is the responsibility of the principal investigator to ensure that registration and results reporting are completed and updated in a timely manner.

If you need assistance or would like more information about the registration process, please email Kerry Moore (kerry. moore@lebonheur.org).