CCRP Certification Exam

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.

Candidate Eligibility

SOCRA offers one comprehensive clinical research certification so there is no need to obtain multiple certifications when you transition to varying roles in the clinical research arena. Available to all persons working in clinical research: SOCRA members enjoy reduced certification fees, while non-members receive complimentary SOCRA membership upon passing the exam. Whether you are independent or affiliated with a research institution, or you’re an investigator, coordinator, monitor, nurse, or any other role – SOCRA’s CCRP is your credential of excellence.

Eligibility Criteria

The applicant must meet one of the following Eligibility Criteria noted below. Please note that most candidates will be eligible under Category 1.

The applicant must be working with Good Clinical Practice (GCP) guidelines under IRB/IEC/REB-approved (or specifically exempted) protocols.

For purposes of eligibility, please view SOCRA’s definition of a Clinical Research Professional.

If you have a question about Candidate Eligibility please email SOCRA at certification@socra.org

Application and Fee

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

Application:

The applicant must submit the following:

• Certification Application:  A completed online certification application.
• Signed Ethics Statement:   Download, sign, date, and return the Ethics Statement with your application portfolio
• Resume / CV:  The applicant’s resume or CV documenting their employment in clinical research.
• Job Description:  The applicant’s official job description issued by each employer/institution for EACH position title documented in the letter(s) of reference.
• Verification of Employment Letter: Include signed/dated letter(s) on institutional letterhead documenting the minimum work experience for the eligibility category. Include letters from EACH employer (supervisor or human resources) documenting EACH position. If required experience spans multiple positions and/or employers, multiple letters will be required.

Letters must include:

• Position title(s) applying toward eligibility
• Corresponding dates of employment for each position title

Full-time or Part-time status for each position title (Include the number of hours/ percentage of time worked in clinical research related duties for each position title)

CCRP® Exam Fees:

Current Members (North America – USA, Canada, Mexico): $510
Current Members (Outside North America): $570
Non-Members (North America – USA, Canada, Mexico): $565
Non-Members (Outside North America): $625
Retest fee within one year of original test date: $390

All funds in US dollars.

Please Note:

For applicants applying under Category 2 or 3, appropriate documentation must be included (see below).

For applicants who have a disability or special need that prohibits them from taking the examination under standard conditions, a written request, along with written confirmation from a physician, must accompany your application form. Requests will be reviewed by the Certification Committee.