Introduction

The Certified Clinical Research Professional (CCRP) credential is administered by the Society of Clinical Research Associates (SoCRA). The CCRP certification validates knowledge and competence in the conduct of clinical research involving human subjects.

The CCRP exam consists of 130 multiple-choice questions (100 scored, 30 unscored) to be completed in 4 hours. A passing score requires answering at least 71 out of 100 scored questions (71%) correctly. The exam is available at PSI testing centers year-round.

The exam content covers the following domains (per SoCRA’s exam content outline):

1. Research Study Start-Up — ~40 scored questions (~40%)
2. •Feasibility assessment and site selection
3. •Regulatory document preparation
4. •Institutional approvals (IRB, ancillary committees)
5. •Budget negotiation and clinical trial agreement (CTA)
6. •Informed consent requirements
7. •Investigator’s Brochure and protocol review
8. Implementation — ~50 scored questions (~50%)
9. •Study conduct (screening, enrollment, randomization)
10. •Source documentation and case report forms
11. •Monitoring and auditing
12. •Investigational product management
13. •Data management and integrity
14. •Safety reporting (SAEs, IND safety reports)
15. Closure — ~10 scored questions (~10%)
16. •Study close-out procedures
17. •Document archiving and retention
18. •Clinical study report (CSR) basics
19. •Subject follow-up requirements

Source: SoCRA — socra.org/ccrp-examination

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Recommended Resources

• •SoCRA CCRP Examination Preparation — SoCRA offers study guides and webinars (socra.org)
• •SoCRA Source Journal — Published quarterly with clinical research articles
• •ICH-GCP E6(R2) Guidelines — The foundational document; read thoroughly
• •FDA Regulations: 21 CFR Parts 50, 54, 56, 312, 812 — Available free at ecfr.gov
• •The CRA’s Guide to Monitoring Clinical Research (Berkowitz) — Practical reference
• •Fundamentals of Clinical Trials (Friedman, Furberg, DeMets) — Textbook on study design
• •GCP: A Question & Answer Reference Guide (Karlberg) — Q&A format for GCP review
• •SoCRA Certification Review Course — In-person or virtual review course offered by SoCRA
• •Clinical Research Coordinator Handbook (Spilker) — Comprehensive operational guide
• •SoCRA Practice Exams — Available through SoCRA membership

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7-Week Study Plan

Phase 1: Regulatory Framework (Weeks 1–2)

Daily Study Time: 2–3 hours

#### Week 1: ICH-GCP & FDA Regulations

Days 1–3: ICH-GCP E6(R2)

• •Read the entire ICH-GCP E6(R2) guideline (available free online)
• •Principles of GCP (Section 2) — all 13 principles
• •Investigator responsibilities (Section 4)
• •Sponsor responsibilities (Section 5)
• •Essential documents (Section 8) — know what must be in the regulatory binder
• •Protocol requirements and amendments
• •Investigator’s Brochure requirements

Days 4–7: FDA Regulations

• •21 CFR Part 50 — Informed consent (8 required elements, 6 additional elements, exceptions)
• •21 CFR Part 56 — IRB composition, functions, operations, review types (full board, expedited, exempt)
• •21 CFR Part 312 — IND application, safety reporting, annual reports
• •21 CFR Part 812 — IDE (investigational device exemptions)
• •21 CFR Part 54 — Financial disclosure by clinical investigators
• •21 CFR Part 11 — Electronic records and electronic signatures

Daily Schedule:

• •1 hour: Read and study regulatory text (highlight key sections)
• •1 hour: 20–25 practice questions on regulations
• •30 min: Make flashcards for key regulatory citations and definitions
• •30 min: Review and organize notes

#### Week 2: Ethics, IRB Oversight & Reporting

Days 1–3: Ethics and IRB

• •Belmont Report — 3 principles (respect for persons, beneficence, justice)
• •Declaration of Helsinki — key provisions
• •IRB review categories (full board, expedited, exempt)
• •IRB continuing review requirements
• •Protocol deviations vs. violations — definitions and reporting
• •Vulnerable populations (children, prisoners, pregnant women, cognitively impaired) — special protections
• •Emergency use provisions

Days 4–5: Safety Reporting

• •Adverse events (AE) vs. serious adverse events (SAE) — definitions
• •IND safety reporting (21 CFR 312.32)
• •Unanticipated problems involving risks to subjects (OHRP guidance)
• •Expedited adverse event reporting
• •SUSAR (Suspected Unexpected Serious Adverse Reaction) reporting
• •MedWatch reporting

Days 6–7: Informed Consent Deep Dive

• •8 required elements of informed consent
• •6 additional elements when applicable
• •Waiver of informed consent criteria
• •Short form vs. long form consent
• •Re-consent requirements (protocol amendments, new information)
• •Documentation requirements
• •Non-English speaking subjects

Daily Schedule:

• •1 hour: Content review
• •1 hour: 20–25 practice questions
• •30 min: Review incorrect answers
• •30 min: Flashcard review

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Phase 2: Clinical Trial Operations (Weeks 3–4)

Daily Study Time: 2–3 hours

#### Week 3: Study Start-Up, Conduct & Essential Documents

Days 1–2: Study Start-Up

• •Feasibility assessment
• •Site selection and qualification visit
• •Pre-study visit (PSV)
• •Regulatory document preparation (Form 1572, CVs, medical licenses, financial disclosure)
• •Institutional approvals (IRB, ancillary committees)
• •Budget negotiation and clinical trial agreement (CTA)
• •Pharmacy setup (accountability, storage, temperature monitoring)

Days 3–5: Study Conduct

• •Subject screening, enrollment, and randomization
• •Visit scheduling and protocol adherence
• •Source documentation (ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate)
• •Case report form (CRF) completion
• •Query resolution
• •Monitoring visits — types, preparation, follow-up
• •Investigational product (IP) management — receipt, storage, dispensing, accountability, return/destruction
• •Protocol deviation identification and reporting

Days 6–7: Essential Documents

• •Before clinical phase begins (initiation documents)
• •During clinical conduct (ongoing documents)
• •After completion/termination (close-out documents)
• •TMF (Trial Master File) organization
• •Document retention requirements (2 years after IND termination or marketing approval per 21 CFR 312.62)

Daily Schedule:

• •1 hour: Content review
• •1 hour: 20–25 practice questions
• •30 min: Review CRA/monitoring workflow scenarios
• •30 min: Flashcard review

#### Week 4: Data Management, Monitoring & Close-Out

Days 1–3: Data Management & Quality

• •Data management plan
• •CRF design and completion guidelines
• •Data entry, validation, and cleaning
• •Database lock procedures
• •Query management
• •Audit trail requirements
• •Electronic data capture (EDC) systems

Days 4–5: Monitoring & Auditing

• •Types of monitoring visits (initiation, interim, close-out)
• •Monitoring plan and report writing
• •Source data verification (SDV)
• •Audit types (sponsor audit, regulatory inspection)
• •FDA inspection process (Form 483, warning letters)
• •CAPA (Corrective and Preventive Actions)

Days 6–7: Study Close-Out

• •Close-out visit procedures
• •IP reconciliation and return/destruction
• •Final data entry and query resolution
• •Document archiving
• •Subject follow-up requirements
• •Clinical study report (CSR) basics

Daily Schedule:

• •1 hour: Content review
• •1 hour: 20–25 practice questions (mixed operations)
• •30 min: Review scenarios and case studies
• •30 min: Cumulative flashcard review

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Phase 3: Scientific Concepts & Study Design (Week 5)

Daily Study Time: 2–3 hours

#### Week 5: Research Design, Biostatistics & Special Topics

Days 1–3: Study Design

• •Clinical trial phases (I, II, III, IV) — purpose and characteristics
• •Study designs: randomized controlled trial, crossover, factorial, adaptive
• •Blinding (single-blind, double-blind, triple-blind)
• •Randomization methods
• •Primary and secondary endpoints
• •Surrogate endpoints
• •Intention-to-treat vs. per-protocol analysis
• •Equivalence, non-inferiority, superiority trials

Days 4–5: Biostatistics

• •Descriptive statistics (mean, median, mode, standard deviation)
• •Inferential statistics (p-value, confidence intervals, Type I and Type II errors)
• •Hypothesis testing (null vs. alternative hypothesis)
• •Power and sample size concepts
• •Kaplan-Meier survival curves
• •Odds ratio, relative risk, hazard ratio
• •Intention-to-treat analysis

Days 6–7: Special Topics

• •Gene therapy and cell therapy trials
• •Pediatric research regulations
• •Expanded access / compassionate use
• •Emergency research (21 CFR 50.24)
• •Good Laboratory Practice (GLP)
• •Good Manufacturing Practice (GMP) for investigational products
• •Multi-site trials and central IRBs

Daily Schedule:

• •1.5 hours: Content review
• •1 hour: 20–25 practice questions
• •30 min: Biostatistics formula review
• •30 min: Cumulative flashcard review

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Phase 4: Practice Exams & Final Review (Weeks 6–7)

Daily Study Time: 2–3 hours

#### Week 6: Full-Length Practice Exams

• •Day 1: Take full 130-question practice exam (SoCRA practice exam or third-party) — timed, 4 hours
• •Day 2: Deep-dive review of practice exam; categorize incorrect answers by domain
• •Day 3: Study weakest domain (likely regulatory or biostatistics)
• •Day 4: Take second full-length practice exam
• •Day 5: Review second exam; update weak-area list
• •Day 6: Targeted study of 2 weakest areas
• •Day 7: Rest / light flashcard review only

#### Week 7: Final Review & Exam Day

• •Day 1: Review all flashcards and high-yield notes
• •Day 2: Re-read ICH-GCP E6(R2) key sections (principles, investigator and sponsor duties)
• •Day 3: Review FDA regulations (Parts 50, 56, 312, 812) — focus on informed consent and IRB
• •Day 4: Light review; focus on SAE reporting timelines and essential documents
• •Day 5: Rest — no heavy studying; confirm exam logistics (PSI test center, valid ID)
• •Day 6: EXAM DAY — Arrive early, bring two forms of valid ID, pace yourself (~1.85 min/question)

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Daily Schedule Template

Total: 2.5–3 hours/day (suitable for working professionals)

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Key Topics — High-Yield Summary

• •ICH-GCP E6(R2): Know the 13 principles, investigator duties, sponsor duties, essential documents
• •21 CFR Part 50: All 8 required and 6 additional informed consent elements
• •21 CFR Part 56: IRB composition (5 members minimum, at least 1 non-scientist, 1 non-affiliated)
• •21 CFR Part 312: IND safety reporting timelines, annual reports, protocol amendments
• •SAE Reporting: 7-day (fatal/life-threatening) and 15-day (other SAEs) expedited reporting to FDA
• •ALCOA+: Attributable, Legible, Contemporaneous, Original, Accurate (+ Complete, Consistent, Enduring, Available)
• •Belmont Report: Respect for persons, beneficence, justice
• •Biostatistics: p-value < 0.05, confidence intervals, Type I/II errors, power

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Test-Taking Tips

1. Know GCP and FDA regulations cold — They make up ~65% of the exam
2. Focus on timelines — Know SAE reporting timeframes, continuing review schedules, document retention
3. Read questions carefully — Many questions test subtle distinctions (e.g., “must” vs. “should”)
4. Eliminate obviously wrong answers — Usually 2 of 4 options can be eliminated quickly
5. Think like a regulator — When in doubt, choose the most protective answer for subject safety
6. Know the definitions — AE vs. SAE, protocol deviation vs. violation, expedited vs. full board review
7. Don’t overthink biostatistics — Questions are conceptual, not computational
8. Review essential documents — Know which documents go in the regulatory binder and when
9. Pace yourself — 4 hours for 130 questions = ~1.85 minutes per question
10. Trust your preparation — SoCRA provides a content outline; if you’ve covered it all, you’re ready

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Sources

• •SoCRA. “CCRP Examination.” socra.org/ccrp-examination
• •SoCRA. “CCRP Examination Content Outline.” socra.org
• •ICH. “Guideline for Good Clinical Practice E6(R2).” ich.org (1996, updated 2016)
• •U.S. FDA. “Code of Federal Regulations Title 21.” ecfr.gov
• •21 CFR Part 11 — Electronic Records; Electronic Signatures
• •21 CFR Part 50 — Protection of Human Subjects
• •21 CFR Part 54 — Financial Disclosure by Clinical Investigators
• •21 CFR Part 56 — Institutional Review Boards
• •21 CFR Part 312 — Investigational New Drug Application
• •21 CFR Part 812 — Investigational Device Exemptions
• •OHRP. “Guidance on Reporting and Review of Adverse Events.” hhs.gov/ohrp
• •U.S. FDA. “The Belmont Report.” hhs.gov/ohrp
• •World Medical Association. “Declaration of Helsinki.” wma.net
• •Friedman, L.M. et al. Fundamentals of Clinical Trials. Springer.
• •Spilker, B. Clinical Research Coordinator Handbook. Lippincott.
• •Karlberg, J.P.E. GCP: A Question & Answer Reference Guide. CARE.