Certificate for Clinical Research Associates: A mixed methods evaluation of the preceptorship component
CCCF ePoster library. Wardell C. Nov 2, 2016; 150990; 109
Christine Wardell
Christine Wardell
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Topic: Education

Certificate for Clinical Research Associates: A mixed methods evaluation of the preceptorship component

Wardell, Christine1; Bryson, Julia2; Barty, Rebecca3; Begin, Helen4; Brons, Sonya5; McDonald, Ellen5; Wolfe, Melanie6; Salama, Suzette7

1Department of Medicine, McMaster University, Hamilton, Canada; 2Biomedical Sciences, University of Guelph, Guelph, Canada; 3Transfusion Medicine, McMaster University, Hamilton, Canada; 4Department of Medicine, St. Joseph's Healthcare, Hamilton, Canada; 5Department of Medicine, Hamilton Health Sciences, Hamilton, Canada; 6Farncombe Institute, McMaster University, Hamilton, Canada; 7Centre for Continuing Education, McMaster University, Hamilton, Canada


The Certified Clinical Research Associate (CCRA) program offered by McMaster University’s Centre for Continuing Education was designed to develop the skills, attitudes and knowledge required to coordinate clinical trials. During the first of five courses (CRA 101), a practical component called 'the preceptorship' is required. The preceptorship experience allows students to observe the daily tasks of research coordinators in two clinical areas.  This experience enables the course participants to appreciate real time situations and challenges encountered by practicing CCRAs.
The primary objective was to determine whether the CRA 101 course learning objectives, including understanding research regulations and ethics, data organization, communication (with patients and colleagues) and practical observation, were being met during the preceptorship experience. The secondary objective was to assess the preceptorship program as a means to ensure students are prepared for a job as a CCRA.
Following each preceptorship, students were required to complete an evaluation by ranking their experience and commenting on what they learned. Data from two cohorts of students (2016) were entered into an excel file and later analyzed by two investigators (JB, CW).
A survey for preceptors was designed based on the student evaluation form. The survey captured demographic data, teaching styles used and perceived effectiveness of the preceptorship program. The survey was piloted and sent electronically via SurveyMonkey® to 16 preceptors. Data were entered into an excel file, collated and analyzed by two investigators (JB, CW).
Our REB waived the need for an application.
A total of 107 evaluations (representing 55 students) and surveys from 13 preceptors were analyzed. Responding preceptors were trained in 7 clinical areas and had been mentors of the preceptorship program for an average of 7.8 years. Students and preceptors cited protocol review, consent and recruitment as top agenda items. Preceptors often tried to include a research facility tour and a patient observation session when able. Many students identified their top lessons as coming from these practical agenda items. Other significant lessons cited by students included organization skills, documentation, obtaining informed consent, and screening patients. In addition to these top lessons learned by students, preceptors emphasized the breadth of professional opportunity and ethic requirements. Finally, students noted that the workload of CCRAs, amount of data management and challenging interactions with patients were unexpected challenges encountered by CCRAs.
All course objectives were covered during the preceptorship experience, with ethics and regulatory requirements being cited most frequently and communication least often. Preceptors cited the importance of teamwork, the patient’s role in the research project, and professional opportunities to be the most significant lessons that they tried to pass on. The students’ responses indicated that they gained more from the practical observations, which gave them new insight to organizational and communication strategies. The effectiveness of the program is evident in that many students noted their exposure to research facilities, organizational methods, patient interactions and many unforeseen challenges which they would not have typically encountered in the classroom.


Clinical Research Associate Courses. Retrieved from www.mcmastercce.ca/cra/courses
SurveyMonkey. Retrieved from www.surveymonkey.com

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