Exam Outline

Examination Content

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 135 multiple choice questions. Five (5) 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 130.   
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 102 of the 130 scored questions.  

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 135 multiple choice questions. Five (5) 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 130.

 

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 102 of the 130 scored questions.  

Five Content Areas and Percent of Scored Test Items (Range) Included in Each Area
  • Ethical Principles / Informed Consent / Safety = 20% - 25%
  • Institutional Review Board / Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities = 7% - 11%
  • Clinical Trial Protocol and Protocol Amendments = 4% - 8%
  • Investigator Roles and Responsibilities = 28% - 32%
  • Sponsor Roles and Responsibilities = 31% - 35%

Exam Outline

Download a Detailed Exam Outline Here
Ethical Principles/ Informed Consent/Safety
  • Nuremberg Code
  • Belmont Report
  • Declaration of Helsinki
  • Informed consent including development, content, review, approval, discussion, documentation and ongoing updates.
  • Maintenance of informed consent documents (paper/electronic)
  • Abstracting/verification of information from medical records related to informed consent and safety reporting
  • Vulnerable subjects
  • Safety Reporting (adverse events, serious adverse drug experiences, unanticipated adverse device effects)
  • Financial disclosure
Investigator’s Roles and Responsibilities 
  • Roles, responsibilities and obligations of the investigator
  • Study conduct in accordance with investigational plan, investigator agreement and applicable regulations
  • Protocol(s) and protocol related document(s) (i.e., informed consent documents, recruitment materials, safety reports, continuing reviews) development, review, and submission for reviewing authorities
  • Recruitment, screening, enrollment, and retention of subjects
  • Investigational site Investigational product accountability including training of subjects
  • Study visits and follow up care
  • Investigational site source documentation
  • Documentation/Reporting discontinuation study subjects
  • Investigational site study related reports (i.e. progress reports, protocol changes, protocol deviations, final reports)
  • Source Documentation/Case Report Forms
  • Maintenance of essential study related documents (paper/electronic)
  • Abstracting/verification of Information from Medical Records
  • Record retention requirements for clinical sites
  • Investigational site Corrective action plans (CAPA)
Institutional Review Board/ Institutional Ethics Committee (IRB/IEC) Roles and Responsibilities 
  • Roles and Responsibilities roles, etc. of IRB/IEC
  • Determination that the rights, welfare and safety of study subjects including vulnerable populations are protected
  • Development and implementation of Standard Operating Procedures (SOPs)
  • Membership
  • Protocol review
  • Significant Risk/Non Significant Medical Device study determination
  • Documentation
  • Development, maintenance of IRB/IEC related documents (paper/electronic)
  • Record retention IRB/IEC
Clinical Trial Protocol and Protocol Amendments 
  • Protocol development (including study design with considerations methods to reduce bias, objectives, endpoints, data safety monitoring)
  • Protocol Amendments
Sponsor’s Roles and Responsibilities
  • Roles, responsibilities and obligations of the sponsor
  • Investigator/site qualifications
  • Investigator Brochure
  • Investigational site training, management, oversight and investigator compliance
  • Protocol(s) and protocol related document(s) (i.e., informed consent documents, recruitment materials, safety reports, continuing reviews) development, review, and submission for reviewing authorities
  • Site/investigator training (GCP, investigational product, study, reporting requirements)
  • Sponsor Investigational product accountability
  •  Standard Operating Procedures
  • Regulatory documents (i.e. FDA Forms 1571, 1572, 3454, 3455, IND, IDE, Medwatch (3500 and 3500A, annual reports, safety reports, final reports)
  • Study Plan
  • Maintenance of essential study related documents (paper/electronic) for sponsors
  • Development, verification, maintenance of electronic records and electronic record systems
  • Monitoring including study coordination, record verification and quality assurance
  • Maintenance of essential study related documents (paper/electronic) for sponsors
  • Abstracting-verification of Information from Medical Records
  • Record retention (Sponsor)
  • Corrective action plans (CAPA)