Survey Finds Certification Signals Higher Professional Self-Assessment of Performance

Stephen Sonstein, PhD

Stephen Sonstein, PhD, Senior Advisor, Multi-Regional Clinical Trials Center

A recent survey by the Joint Task Force for Clinical Trial Competency (JTF) and the Multi-Regional Clinical Trials Center (MRCT) found that, for every domain in the JTF Competency Framework, clinical research professionals who were certified through either the Association of Clinical Research Professionals (ACRP) or SoCRA expressed much higher levels of self-assessed competency than did individuals without professional certification.

The JTF conducted a global survey of clinical research professionals requesting respondents to self-assess their competencies in each of the eight domains of its Core Competency Framework (version 3.1). Results were interpreted based upon role, years of experience, educational level, professional certification, institutional affiliation, and continuing education participation. The results appear in a recent issue of Therapeutic Innovation & Regulatory Science, a publication of the Drug Information Association (DIA).

“The survey demonstrated that, irrespective of role, experience, or educational level, training curricula in both pre-professional and continuing professional education should include additional content relating to research methods, protocol design, medical product development and regulation, and data management and informatics,” survey authors wrote.

“Certification is indeed valuable, and we must expand education and training in the domains that our survey found might be lacking,” said Stephen Sonstein, PhD, a senior advisor with MRCT Center at the Brigham & Women’s Hospital and Harvard and a coauthor of the DIA paper.

The survey found three domains demonstrated the greatest need for additional education and training:

  • Scientific Concepts and Research Design
  • Investigational Product Design and Regulation
  • Data Management and Informatics

One of original JTF objectives was to help make clinical research professionals aware of their education and training needs and to stimulate further efforts to enhance their competency.

Of 661 respondents to the survey, only 174 (35.7%) reported attending academic coursework or continuing education training in the past two years. Of those who did, the most common education/training topics were in the domains of:

  • Clinical Study Operations/Good Clinical Practice
  • Ethical and Safety Considerations

Respondents working in Corporate Pharmaceutical/Biotechnology positions reported higher levels of competency in the domains of Investigational Product Development and Regulation as well as Communication and Teamwork.

Private Clinical Site respondents reported the lowest levels of competency in the Scientific Concepts and Research Design and Communication and Teamwork domains.

Author: Michael Causey