2011 - NIH Clinical Center - National Institutes of Health

CLINICAL CENTER OFFERS SABBATICAL IN CLINICALRESEARCH MANAGEMENTThe Clinical Center’s Sabbatical in ClinicalResearch Management program provides wideaccess to the knowledge, expertise, and experienceof leaders at the NIH.The program started accepting applications in2009 from a limited number of those who areexperienced in the world of clinical research butwant to learn more about management of a clinicalresearch enterprise.The four participants inthe pilot phase of the sabbatical program chose anindividualized set of electives and received oneon-oneattention from managers, executives, andclinician-scientists.The elective leaders are mainlyfrom the CC, but other educational partnersinclude other NIH institutes and centers, the USFood and Drug Administration (FDA), the HHSOffice for Human Research Protections, and theFoundation for the NIH.Dr. Roman Ivanov traveled from Russia to participatein the Sabbatical in Clinical Research Managementfor three months in 2010.As a researcherat both a biotechnology company and an academicmedical center, Ivanov was curious to learn aboutprotocol writing and tracking and patient recruitment,as well as the regulatory aspects of clinicalresearch. Spending a month full-time at theFDA and two months at the NIH developingan ongoing project allowed him to meet hiseducational goals.“The program provided me with a uniqueopportunity to get a better understanding of theinfrastructure required for investigator-associatedclinical trials and regulatory issues associated withthem. I will do my best to share this knowledgewith my colleagues and I hope that this willontribute to development of medical sciencein Russia,” Ivanov said.This is a major goal of the sabbatical program:giving participants hands-on experience in clinicalresearch management so that they may apply whatthey learn at their home institutions. Opening theCC’s doors allows individuals to learn from thescience, the management and operations, and theunique circumstances under which we conductclinical and translational research conducted here.“This program provides management training tohelp ensure that medical research programs are safe,ethical, and efficient,” said CC Director Dr. JohnI. Gallin.“The sabbatical will help demystify thecomplexities of governmental regulatory agencieswhile providing an opportunity to achieveexcellence in clinical research management.”ANNUAL REPORT 2011• 45