2023-2024 SOCRA Annual Report - Flipbook - Page 8
SOCRA 2021 ANNUAL REPORT
CERTIFIED CLINICAL RESEARCH
PROFESSIONAL PROGRAM
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. Certified individuals may use the title “Certified Clinical Research
Professional” or CCRP®.
EXAM 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 psychometric analysis.
SCOPE
The Clinical Research Professional
Certification program is intended to
evaluate a CRP’s knowledge,
understanding, and ability to apply
regulations to the conduct of clinical
investigations involving humans.
Knowledge areas include: the International
Counsel on Harmonisation Guideline for
Good Clinical Practice (ICH E6 GCP), ICH
Clinical Safety Data Management:
Definitions and Standards for Expedited
Reporting (E2A), the United States Code of
Federal Regulations (CFR) Parts 11, 50, 56,
312, 812, and the ethical principles that
guide clinical research consistent with the
principles of the Nuremberg Code, the
Belmont Report and the Declaration of
Helsinki.
EXAM DESCRIPTION
The examination is made up of multiple
choice questions. The questions are
formulated to be straight-forward and
easily understood. 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
certification examination is offered in the
English language.
The CCRP exam Certification examination
has no testing windows and the exam is
offered in paper and pencil and computer
based testing formats.
EXAM SCORING
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
data collected on the unscored items is
used to evaluate the psychometric
soundness of each CCRP test item. 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”.
CCRP EXAM STATS
Donna Headlee, RN, BSN, CCRP
Program Chairperson,
Certification Committee
EXAM CONTENT
The CCRP® certification
examination is organized into
three major content areas. See
below for the areas and the
percent of test items in each
area:
Research Study Start-Up
40%
11,849 CERTIFIED
Regulatory Requirements of IRB/
IEC, sponsors and investigators
related duties/task related to
study start up
946 CANDIDATES
TOOK THE EXAM
Research Study
Implementation
65% PASSED
THE EXAM
45%
Regulatory Requirements of IRB/
IEC, sponsors and investigators
related duties/task related to
conduct of the study
Research Study Closure
2,715+ CCRPS
RECERTIFIED
15%
Regulatory Requirements of IRB/
IEC, sponsors and investigators
related duties/task related to
study close out and record
maintenance
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