CCRP study plan
CCRP · Give each week a clear focus.
8 weeks · About 6 hours per week
Clinical Research Professional Knowledge, Education, and Experience Standard
Map the Domain 1 blueprint into a written outline of the clinical research professional's scope of practice, roles, and responsibilities
Define and differentiate the core study documents (protocol, investigator's brochure, informed consent form, case report form) in your own words
List the phases of clinical research and state the purpose and typical design features of each
Draft a one-page glossary of foundational clinical research terminology
Your checkpoint
A 2-page Domain 1 concept map plus a 25-term glossary in your own words
Clinical Research Professional Knowledge, Education, and Experience Standard
Explain the purpose and key requirements of Good Clinical Practice principles and how they apply to study conduct
Describe the roles of sponsor, investigator, site staff, institutional review board, and regulatory authority in oversight
Outline the essential elements of a protocol and identify which elements drive participant safety
Summarize how study documentation and recordkeeping support data integrity
Your checkpoint
A written comparison table of stakeholder responsibilities and a 10-item protocol-elements checklist
Clinical Research Professional Knowledge, Education, and Experience Standard
Describe the informed consent process as a regulated activity, including timing, documentation, and re-consent triggers
Explain how eligibility criteria, randomization, and blinding affect participant protection and data quality
Outline safety reporting concepts including adverse events, serious adverse events, and expectedness
Identify common protocol deviations and classify each as major or minor with justification
Your checkpoint
A deviation-classification worksheet with 12 scenarios answered and justified
Clinical Research Professional Knowledge, Education, and Experience Standard & Ethical Practices and Protection of Research Participants
Consolidate Domain 1 knowledge by teaching back the study lifecycle from concept to closeout in a timed outline
Define the core ethical principles that govern research with human participants and state how each translates into practice
Identify historical cases that shaped modern research ethics and extract the specific safeguards each produced
Begin a personal error log of missed practice questions tagged by domain
Your checkpoint
A 30-question self-made Domain 1 quiz with answer key and a written ethics-principles summary
Ethical Practices and Protection of Research Participants
Analyze the informed consent process for voluntariness, comprehension, and freedom from coercion using case scenarios
Evaluate recruitment and compensation practices for undue influence and identify corrective actions
Explain protections for vulnerable populations and justify additional safeguards for each group
Apply privacy and confidentiality requirements to realistic data-handling scenarios
Your checkpoint
Four written case analyses (consent, recruitment, vulnerable populations, confidentiality) each with a defensible recommendation
Ethical Practices and Protection of Research Participants
Describe the composition, function, and review responsibilities of an institutional review board
Distinguish among exempt, expedited, and full review and justify the correct pathway for given studies
Outline reporting obligations for unanticipated problems, noncompliance, and protocol changes
Analyze conflicts of interest and describe disclosure and management strategies
Your checkpoint
A review-pathway decision tree plus eight scenarios classified by review type and reporting obligation
Clinical Research Professional Knowledge, Education, and Experience Standard & Ethical Practices and Protection of Research Participants
Integrate Domain 1 and Domain 2 concepts by answering mixed-format practice questions under timed conditions
Review every entry in your error log and rewrite the underlying rule for each missed item
Rehearse ethical decision-making by writing short justifications for scenario-based answers
Close remaining knowledge gaps identified from your error log by targeted re-study
Your checkpoint
A timed 60-question mixed practice set with a scored report and a fully resolved error log
Clinical Research Professional Knowledge, Education, and Experience Standard & Ethical Practices and Protection of Research Participants
Summarize each domain into a single high-yield review sheet written from memory
Complete a full-length timed practice exam and record per-domain performance
Identify and re-study the three weakest subareas revealed by the practice exam
Draft a test-day plan covering timing strategy, question-reading approach, and flag-and-return tactics
Your checkpoint
A full-length timed practice exam score report with a written remediation plan and test-day strategy sheet
Milestones
Week 2: Score at least 80% on a self-made 20-question Domain 1 quiz covering roles, GCP, and documentation
Week 4: Explain the full study lifecycle and all core ethical principles aloud in under 10 minutes without notes
Week 6: Correctly classify at least 7 of 8 scenarios by IRB review pathway and reporting obligation
Week 8: Achieve at least 80% overall on the full-length timed practice exam with no domain below 75%