Exam Overview

Purpose

SOCRA established the Certification Program for Clinical Research Professionals in order to create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the clinical research community. Those individuals so approved may use the title "Certified Clinical Research Professional" or "CCRP® (SOCRA)"

Background Information

Clinical research professionals come from a wide variety of backgrounds with even more varied job descriptions. Some clinical research professionals are MDs, while other are RNs; some may have a degree in medical technology, business administration, health information management, statistics, biology, teaching, or other areas. Every one of these backgrounds brings special areas of expertise to the field of clinical research. Each institution and discipline has unique requirements.

Despite the varied backgrounds and job descriptions, all clinical research professionals are guided by a common framework of regulations, guidelines and ethical principles in the conduct of clinical research. Therefore, the examination is designed to assess the applicant’s ability to apply the U.S. Code of Federal Regulations, ICH Guidelines, and ethical principles that guide the conduct of clinical research under the scope of GCP, highlighted in the standards of practice.

Examination Development

The Certification Examination has been developed by the SOCRA Certification Committee and SOCRA Certified Clinical Research Professionals (CCRPs) who have demonstrated expertise in the development, management, and administration of clinical trials. These clinical research subject matter experts (SMEs) come from diverse backgrounds and job descriptions to reflect the composition of SOCRA membership.

The test questions are designed to be straightforward and easily understood. The questions are reviewed by experts in test question development and SOCRA language representatives for fairness and readability.

The Certification Examination is evaluated and updated at least annually in order to assure that it is up-to-date and reflective of the current regulatory environment in which clinical trials are performed.

The certification exam content areas have been reviewed and validated through completion of a Job/Task Analysis. A copy of the Job / Task Analysis summary is available by request through the SOCRA administrative office.

Examination Validation

The exam is statistically and psychometrically validated by independent consultants. The Certification Committee evaluates the results from statistical/psychometric evaluations and updates the exam as needed.

The examination pass/fail score, or “cut score”, is statistically determined by a panel of experts using the "Modified Angoff Method." The “cut score” is validated after a review of the psychometric testing analysis.