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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.

 


How can SOCRA CCRP certification benefit my career? 

The Certified Clinical Research Professional (CCRP) Certification by SOCRA is based on a continuing process of professional experience and education. This program is dedicated to providing recognition and validation of the professional growth of the individual CCRP ® to the healthcare community.

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. Clinical research professionals come from a wide variety of backgrounds with even more varied job descriptions. Some clinical research professionals are MDs, while others 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.

How do I prepare for the SOCRA CCRP Certification Exam?

To prepare for the exam, a candidate should study the detailed exam outline and consider the knowledge, skills, and abilities needed to perform the duties of a clinical research professional (CRP). Satisfactory completion of the CCRP ® certification examination indicates that the candidate has met all the eligibility criteria and has demonstrated knowledge of the key duties/tasks of a CRP. 

Content areas on the examination that deal with topics concerning your daily job requirements should not require extensive study on your part; it is anticipated that this is part of your working knowledge. Content areas appearing on the examination that are not part of your daily job requirements may require some research and study. For instance, if you do not deal with Institutional Review Boards (IRB), you will want to study the requirements of this aspect of clinical research.

Please remember that the examination assesses your knowledge and understanding of the United States Code of Federal Regulations and the International Conference of Harmonisation E6 & E2A Guidelines. It does not assess state, local, provincial, Ministry of Health, or institutional policy. 

Please see the Exam Outline to review the list of the ethical principles, FDA regulations and forms, and ICH guidelines that are included in the scope of the exam.

https://www.socra.org/certification/ccrp-certification-exam/preparing-for-the-exam/

https://www.socra.org/certification/ccrp-certification-exam/exam-outline/

What are the requirements to maintain my CCRP Certification?

The certification period is three years, beginning on the date of the most recent certification and ending on the certification expiration date.   All CE must be accrued during this time period. Certificants must have completed 45 hours (45 credits) of CE during their certification period. A minimum of 22 CE must be related to Clinical Research regulations, policy, etc. The remaining CE may relate to your Therapeutic or Professional Area. 1 CE will be awarded for the successful completion of the recertification continuing competence learning module. Only educational hours may be claimed for CE; you may not claim CE credit for your work hours. In order to maintain active certification status, the CCRP ® must apply for renewal of certification to the Certification Committee every three years. 

How much does it cost to take the CCRP Exam?

Applicants should thoroughly review all of the information provided in the Certification section of the website.  Before submitting an application packet, applicants must review the eligibility requirementsapplication procedures, and certification program policies and procedures.

CCRP ® Exam Fees:

Current Members: $395*

Non-Members: $450*

CBT (Computer Based Testing): additional $115 (North America - USA, Canada, Mexico), additional $175 countries outside North America

All funds in US dollars.