SOCRA-CCRP Exam Format | Course Contents | Outline | Syllabus | Objectives

SOCRA-CCRP Exam Syllabus & Study Guide

Before you start practicing with our exam simulator, it is essential to understand the official SOCRA-CCRP exam objectives. This course outline serves as your roadmap.

The information below reflects the 2026 syllabus defined by SOCRA.

Below are complete topics detail with latest syllabus and course outline, that will help you good knowledge about exam objectives and topics that you have to prepare. These contents are covered in questions and answers pool of exam.

SOCRA-CCRP Certified Clinical Research Professional (CCRPI) 1. Research Study Start-Up (40%) - Coordinate the development of initial research study protocol - Determine if a research study design involves human subjects - Develop Standard Operating Procedures (SOPs) - Coordinate expedited review of research study protocol - Coordinate emergency use research study protocol - Coordinate protocol involving vulnerable subjects - Coordinate protocol involving investigational products - Create or obtain research study documents - Informed consent documents - Informed assent documents - Essential documents - Case Report Forms (CRFs) - Financial disclosure statements - Delegation logs - IND/IDE documentation - Clinical investigator agreements - Regulatory documents - Obtain research study approval from necessary stakeholders - Sponsor approval - IRB/IEC approval - Regulatory authority approval - Obtain research study product, related materials, equipment, tools and aids - Research study tools - Data management systems - Data collection tools - Select research study sites - Train research study staff members - Staff qualification evaluation - Training program development - Training administration - Evaluate research study compliance with relevant local, state and provincial laws - IRB compliance - ClinicalTrials.gov requirements - Local, state and provincial regulations - Data Safety Monitoring Board (DSMB) 2. Research Study Implementation (50%) - Execute research study - Follow protocol - Follow SOPs - Evaluate protocol - Continuing review submissions - Protocol amendments - Assure regulatory compliance - Local, state and provincial laws - Privacy laws - Manage research study product - Prepare study products - Dispense study products - Administer study products - Store study products - Verify study product use - Identify, document and report research study anomalies - Protocol deviations - Protocol violations - Unanticipated problems - Adverse events - Serious adverse events - Adverse device effects - Research misconduct - Manage subjects - Recruit subjects - Evaluate eligibility - Capacity for consent - Document eligibility - Explain study methodology - Obtain informed consent - Obtain informed assent - Document informed consent - Subject discontinuation - Coordinate family/caregiver interactions - Document interactions - Subject communication - Maintain the research study - Training documentation - Research equipment - Delegation log - Essential documents - Medical records - ClinicalTrials.gov information - Regulatory documents - Data queries - Site record verification - Audits - Monitoring visits - Regulatory inspections - Communicate with research study stakeholders - IRB - Sponsor - Data Safety Monitoring Board (DSMB) - Regulatory authorities - Study sites - Case Report Forms (CRFs) - Perform/participate in a research study audit - Essential document maintenance - Source document maintenance - Quality Control (QC) - Quality Assurance (QA) - Regulatory inspections 3. Research Study Closure (10%) - Perform/participate in a research study closeout visit - Essential document verification - Resolution of monitoring queries - Investigational product accountability - Develop and submit research study closure reports - IRB closure report - Sponsor final report - Regulatory authority final report - ClinicalTrials.gov final report - Archive/retrieve study records