INTRODUCTION: Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This article describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the United States. METHODS: A total of 692 applications were received from CRMs in 50 countries. Of these, 166 were admitted to the program in two cohorts. The program, taught online and in English, included 4 required and 1 optional course. Course materials were also provided as hard copies and on CDs. A pretest/posttest design was used to evaluate the outcome of the program in terms of changes in knowledge, participants' capacity-building activities at their research sites; and participant and supervisor perceptions of program impact. RESULTS: Participants demonstrated significant improvements in knowledge about clinical research, rated course content and teaching strategies positively, and identified the opportunity for interactions with international peers as a major program strength. Challenges for participants were limited time to complete assignments and erratic Internet access. Participants offered capacity-building programs to 5061 individuals at their research sites. Supervisors indicated that they would recommend the program and perceived the program improved CRM effectiveness and site research capacity. DISCUSSION: Results suggest that this type of continuing education program addresses a growing need for education of CRMs working in countries that have previously had limited involvement with global clinical trials.
INTRODUCTION: Due to the increasing number of clinical trials conducted globally, there is a need for quality continuing education for health professionals in clinical research manager (CRM) roles. This article describes the development, implementation, and evaluation of a distance-based continuing education program for CRMs working outside the United States. METHODS: A total of 692 applications were received from CRMs in 50 countries. Of these, 166 were admitted to the program in two cohorts. The program, taught online and in English, included 4 required and 1 optional course. Course materials were also provided as hard copies and on CDs. A pretest/posttest design was used to evaluate the outcome of the program in terms of changes in knowledge, participants' capacity-building activities at their research sites; and participant and supervisor perceptions of program impact. RESULTS:Participants demonstrated significant improvements in knowledge about clinical research, rated course content and teaching strategies positively, and identified the opportunity for interactions with international peers as a major program strength. Challenges for participants were limited time to complete assignments and erratic Internet access. Participants offered capacity-building programs to 5061 individuals at their research sites. Supervisors indicated that they would recommend the program and perceived the program improved CRM effectiveness and site research capacity. DISCUSSION: Results suggest that this type of continuing education program addresses a growing need for education of CRMs working in countries that have previously had limited involvement with global clinical trials.
Authors: Jeffrey M Taekman; Gene Hobbs; Linda Barber; Barbara G Phillips-Bute; Melanie C Wright; Mark F Newman; Mark Stafford-Smith Journal: Anesth Analg Date: 2004-08 Impact factor: 5.108
Authors: Seth W Glickman; John G McHutchison; Eric D Peterson; Charles B Cairns; Robert A Harrington; Robert M Califf; Kevin A Schulman Journal: N Engl J Med Date: 2009-02-19 Impact factor: 91.245