Testing After October 20, 2019

Exam Outline - Testing After to October 20, 2019

The CCRP ® certification examination is organized into three major content areas derived from the 2017 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. The questions 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 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”.  In order to achieve a passing score, candidates must correctly answer 72 of the 100 scored questions.  

Three Content Areas and Percent of Scored Test Items (Range) Included in Each Area

    Major Content Area

    Brief Description

    Approximate
    % of Exam
    Research Study Start-Up
    Regulatory Requirements of IRB/IEC, sponsors and investigators related duties/task related to study start up
    40
    Research Study Implementation
    Regulatory Requirements of IRB/IEC, sponsors and investigators related duties/task related to conduct of the study
    45
    Research Study Closure
    Regulatory Requirements of IRB/IEC, sponsors and investigators related duties/task related to study close out and record maintenance
    15

Exam Outline

Download a Detailed Exam Outline Here
Research Study Start-Up – Approximately 40 questions
  • Coordinate the development of initial research study protocol
  • Create or obtain research study documents (e.g., informed consent, essential documents, case report forms, financial disclosure statements)
  • Obtain research study approval from necessary stakeholders (i.e., IRB, research study sponsor, and relevant regulatory authorities)
  • Obtain research study product, related materials, equipment, tools and aids
  • Select research study sites
  • Train research study staff members
  • Evaluate research study’s compliance with relevant local, state and provincial laws
Research Study Implementation---Approximately 45 questions
  • Execute research study in accordance with the protocol
  • Assure regulatory compliance
  • Manage research study product (e.g., treatment, procedure, medication, medical device, questionnaire)
  • Identify, document & report research study anomalies
  • Manage subjects
  • Maintain the research study
  • Communicate with research study stakeholders
Research Study Closure—Approximately 15 questions
  • Perform/participate a research study closeout visit 
  • Perform/participate a research study audit 
  • Develop & submit research study closure reports
  • Archive/retrieve research study records