February 2024 SOCRA Source Journal - Journal - Page 80
CCRP® CERTIFICATION PROGRAM
for Clinical Research Professionals
Statement of 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 recognized
may use the “Certified Clinical Research Professional” or “CCRP®” designation.
Definition of a Clinical Research Professional
A clinical research professional’s (CRP) practice is guided by the principles of Good Clinical Practice (GCP)
(ICH E6 and FDA regulations).
A CRP may function as a clinical investigator, sub-investigator, clinical researcher, research nurse, pharmacist, administrator,
coordinator, consultant, data manager, quality assurance manager, regulatory affairs manager or educator in clinical trial management.
The duties of a CRP may include data collection, analysis, or monitoring; case management of protocol participants; recruitment and
enrollment of human subjects; protection of subjects and subjects’ rights; development of informed consent documents; preparation
of adverse event experience reports; construction or monitoring of case report forms; maintenance of drug accountability records;
development of grants and budgets; preparation of reports; educating other healthcare professionals, patients or families about
clinical trials; protocol development; program administration; or research program audit.
A CRP would not include professionals working exclusively under Good Laboratory Practice (GLP) and/or Good Manufacturing
Practice (GMP) regulations.
Examination Content
The CCRP® certification examination is organized into five major content areas derived from the 2012 SOCRA Job/Task Analysis.
The examination content outline provides a detailed description of the content areas including topic areas and knowledge domains.
Each question on the exam is based on the content outline. To prepare for the exam, a candidate should study the detailed outline
and consider the knowledge, skills, and abilities needed to perform the duties of a 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.
The questions assess understanding and application, not just the ability to recall facts. Some questions are based on scenarios and
case studies that relate to clinical research practice. The case studies and scenarios are intended to evaluate a candidate’s ability to
abstract information and do not require clinical (medical) experience.
Each test question has only one correct answer. Each question is weighted equally, and there is no penalty for an
incorrect answer. Therefore, it is advantageous to answer all questions.
The CCRP certification examination consists of 130 multiple choice questions. Thirty (30) of these questions are “beta test”
questions and will not affect the candidate’s score (unscored). These items are not identified to the candidate. The number of scored
items on the exam is 100.
The passing score is determined by a panel of experts using the "Modified Angoff Method." In order to achieve a passing score,
candidates must correctly answer 72 of the 100 scored questions.
Three Content Areas & Percent of Scored Items in Each Area
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.
1
2
3
Research Study Start-Up - Regulatory Requirements of IRB/
IEC, sponsors and investigators related duties/task related
40%
Research Study Implementation - Regulatory Requirement
of IRB/IEC, sponsors and investigators related duties/task
related to conduct of the study
45%
Research Study Closure - Regulatory Requirement of
IRB/IEC, sponsors and investigators related duties/task
related to study close out and record maintenance
*an extended version of the outline can be downloaded at socra.org/certification
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SOCRA SOURCE © May 2023
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