Citation

Honari S, Caceres M, Romo M, Gibran NS, Gamelli RL. J. Burn Care Res. 2015; 37(2): 127-134.

Affiliation

From the *University of Washington Regional Burn Center, Harborview Medical Seattle; and †Loyola University Medical Center, Maywood, Illinois.

Copyright

(Copyright © 2015, American Burn Association, Publisher Lippincott Williams and Wilkins)

DOI

10.1097/BCR.0000000000000264

PMID

26132051

Abstract

As health-care complexity and costs increase, evidence-based research has become essential to the advancement of burn care. Multicenter trials involve procedures, regulations, and guidelines that require meticulous attention to details and strict adherence to compliance issues. Taking on a large, multicenter trial can be a daunting task for a new burn research coordinator. The purpose of this article is to provide a resource for new burn research coordinators in multicenter clinical trial planning, especially in the field of burns. The burn research coordinator must possess organizational and multitasking skills, attention to detail, professionalism, initiative, and motivation. The burn research coordinator must exercise five principles of practice: compliance, confidentiality, consistency and correctness, and collaboration. Compliance assures subject safety, study integrity, and burn center reputation. Confidentiality is essential, especially when handling sensitive health information. Maintaining subject privacy through secure links and destruction of linked data in a timely matter protects the subjects and complies with the regulations of many governing bodies. Consistency and correctness minimize human errors through continuous data validation and self-auditing and peer auditing. Collaboration between the Principal Investigator/burn research coordinator and all departments involved in the study maintains the study focus and allows for enforcement of procedures. Preparing a budget confirms adequate compensation for work done by the research team and can be broken down into the following five steps: protocol review, calculation of initial payment, establishment of indirect costs, calculation of direct costs, and budget negotiation. Over time, one becomes familiar with the details involved with study success. Advocating for subject safety and protocol adherence are of highest priority. Study design is the most important element that dictates the success of the study. Anticipating the direct and indirect costs of a particular trial assures that the study can be completed with adequate allotment for staff time, laboratory costs, and supplies. Regular communication with the Principal Investigator, clinical staff, and consultants is vital for study completion. An essential contributor to burn research and the advancement of burn care, the burn research coordinator must balance many study-related tasks. Through the practice of compliance, confidentiality, and organization/planning, the burn research coordinator can ensure proper study management. These recommendations may assist new burn research coordinators in their practice.

Language: en