Coordination of a neural tissue transplantation study in patients with posttraumatic syringomyelia.
The need for clinical research coordinators (CRCs) has grown in recent years due to the increasingly rapid translation of scientific advances from preclinical experiments to clinical trials. CRCs perform a number of critical roles in clinical trials, such as ensuring adherence to the research protocol and careful monitoring of the study data. Although many of these duties are now standardized in a general job description, new fields of clinical research may require additional functions of the CRC that are specific to each investigation. This was the case for a pilot clinical study at the University of Florida, which investigated the feasibility and safety of human fetal spinal cord (FSC) tissue allografts in patients with progressive posttraumatic syringomyelia (PTS). The CRC for this study had several essential duties, such as arranging transportation for PTS subjects to the study center from all regions of the United States and coordinating an extensive assessment protocol that required many co-investigators. Given these challenges, successful achievement of the outcome measures required the development of a customized CRC job description that encompassed both standard roles and specific duties for this study. Accordingly, this article will illustrate the role of the CRC in this study and provide a template for similar coordinator roles.
Forthofer
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Chicago Institute of Neurosurgery and Neuroresearch, Chicago, Illinois, USA.
Wirth
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D015400:Clinical Nursing Research / Q000379:methods / Q000458:organization & administration*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007587:Job Description; D008875:Middle Aged; D009417:Nerve Tissue / Q000637:transplantation*; D018579:Patient Selection; D013119:Spinal Cord Injuries / Q000150:complications*; D013595:Syringomyelia / Q000209:etiology / Q000451:nursing / Q000601:surgery*