November 2024 SOCRA Source Journal - Journal - Page 84
CCRP® CERTIFICATION PROGRAM
for Clinical Research Professionals
Statement of Purpose
SOCRA established the Certi昀椀cation 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 “Certi昀椀ed Clinical Research Professional” or “CCRP®” designation.
De昀椀nition 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 a昀昀airs 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® certi昀椀cation examination is organized into 昀椀ve 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
certi昀椀cation 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 certi昀椀cation examination consists of 130 multiple choice questions. Thirty (30) of these questions are “beta test”
questions and will not a昀昀ect the candidate’s score (unscored). These items are not identi昀椀ed 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 "Modi昀椀ed Ango昀昀 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
Certi昀椀cation 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 "Modi昀椀ed Ango昀昀 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 to study start up
Research Study Implementation - Regulatory
Requirement of IRB/IEC, sponsors and investigators
related duties/task related to conduct of the study
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/certi昀椀cation
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SOCRA SOURCE © November 2024
40%
45%
15%
