J Korean Soc Clin Pharmacol Ther.
2011 Dec;19(2):130-143.
The Study of Education and Qualification for the Maintenance of Clinical Research Associate (CRA) Professionalism
- Affiliations
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- 1Graduate School for Public Health, The Catholic University of Korea, Korea.
- 2Department of Family Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Korea.
- 3Nicholas Cardinal Cheong Graduate School for Life, The Catholic University of Korea, Office of Human Research Protection, Catholic Medical Center, The Catholic University of Korea, Korea.
- 4Department of Neurology, Seoul St. Mary's Hospital, The Catholic University of Korea, Korea. nuyikim@catholic.ac.kr
Abstract
- BACKGROUND
The aim of the current study is to investigate perspectives on the quality and validity of the current clinical research associate (CRA) education program. The trainee program of other healthcare professions including medical doctors, registered nurses, and pharmacists, has been already reviewed as an advance research. Thus, the current study evaluates the CRA education system to assist in building a more suitable CRA education infrastructure in the future.
METHODS
A questionnaire was handed out to CRAs with at least 3 months working experience among 30 pharmaceutical corporations, and 10 Contract Research Organizations (CROs) affiliated with the Korean Pharmaceutical Association and the Korean Clinical Research Committee. A total of 118 questionnaires were utilized for data analysis.
RESULTS
The poll shows that 93.2 % of the survey participants consider the role of a CRA as a specialized healthcare profession and 58.6 % of those respondents reason that becoming a CRA requires specialized knowledge. 95.9 % of survey participants attend a CRA trainee program for the maintenance of CRA professionalism. The respondents are inclined to attend the Government hosted CRA education program. 59.3 % of survey participants answered that implementing a CRA qualification system is necessary to establish a CRA specialty validation.
CONCLUSION
The current study demonstrates the importance of qualification and what is necessary for being a CRA. The study result will provide a guideline for those who wish to become a CRA as part of their career. In addition, the result will also be used in developing an improved CRA education program in the future.
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