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- W2029649934 abstract "Background: Conducting clinical trials in the field of Trauma presents many challenges. One of these challenges is the possibility of patient enrollment at any time. Enrollment often occurs after hours during which resources are limited. Objective: A Research Assistant (RA) model at a Level I Regional Resource Trauma Center was designed to support participation and to facilitate enrollment in a national multicenter clinical trial. Methods: Sixteen staff clinicians were chosen by predetermined criteria. An information session and four training sessions were implemented. Upon completion of the training session all research assistants were scheduled for call via an internet based calendar. A response protocol included a ten minutes response by telephone and an arrival time of 30 minutes. Variables assessed via retrospective evaluation of case report forms (CRF) were protocol violations, availability, after hour enrollment and successful completion of enrollments. After hours was defined as enrollment occurring during weekends, holidays and between 5pm to 8am Monday through Friday. Results: Sixteen clinicians (14 RN, 1PCT, 1 EMT) made up the RA team. There were a total of 13 patients enrolled over an 18 month period. Seven of 13 (41%) patient enrollments were managed by a RA. Eight of 13 (61%) patients were enrolled during after hours. On two occasions, the research assistants were non-compliant with the response protocol. A back up RA was available in both cases. No protocol violations were noted. All patients were successfully enrolled with completed CRF. Conclusion: Implementation of a Research Assistant model allows for successful participation in Trauma clinical trials. This utilization of resources aids in the conduction of such important trials at institutions where resources are limited. This model may serve as a template for smaller institutions in participating in trauma clinical trials." @default.
- W2029649934 created "2016-06-24" @default.
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- W2029649934 date "2008-02-01" @default.
- W2029649934 modified "2023-09-23" @default.
- W2029649934 title "QS187. Meeting The Challenge of Conducting a Clinical Trial in Trauma Utilizing a Research Assistant Model" @default.
- W2029649934 doi "https://doi.org/10.1016/j.jss.2007.12.431" @default.
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