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Keywords:

  • international research;
  • global clinical trials;
  • research coordinator education

Abstract

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.