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CCRC Cheat Sheet

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Scientific Concepts & Research Design

  • 8% of exam
  • Study Design Trial Phases Endpoints Statistics

Ethical & Participant Safety

  • 19% of exam
  • Informed Consent Ethical Principles Adverse Events Vulnerable Populations

Product Development & Regulation

  • 13% of exam
  • Regulatory Submissions ICH Guidelines IND vs IDE Clinical Hold

Clinical Trial Operations (GCPs)

  • 23% of exam
  • GCP Roles Essential Documents Monitoring Protocol Deviations

Study & Site Management

  • 22% of exam
  • Site Lifecycle IP Handling Enrollment Site Budget

Data Management & Informatics

  • 15% of exam
  • ALCOA+ Data Tools Source Documents Record Retention

Quick Facts

  • Exam CCRC
  • Credential ACRP Clinical Research Coordinator
  • Questions 125 (100 scored)
  • Time 180 min
  • Pass Scaled 600
  • Format Computer-based, PSI
  • Level Professional
  • Blueprint 2024 ECO

Trial Phase Progression SC

  • Safety, then dose, then confirm, then market
  • Phase I: safety Phase II: dosing Phase III: confirms Phase IV: post-market

Study Design Terms SC

  • Protocol Trial's objectives and methodology
  • Investigator's Brochure (IB) IP clinical/nonclinical data summary
  • Primary endpoint Pre-specified main outcome measure
  • Secondary endpoint Additional supportive outcome measure
  • Randomization Chance-based group assignment
  • Stratification Balances key variables across groups
  • Statistical power Detects true treatment effect
  • Blinding levels Single, double, triple mask

Clinical Trial Phases SC

  • Phase I Safety, small healthy-volunteer group
  • Phase II Dose-finding, preliminary efficacy
  • Phase III Large confirmatory efficacy trial
  • Phase IV Post-marketing surveillance

Belmont Report Principles ET

  • Respect, Beneficence, and Justice guide ethics
  • Respect: honor autonomy Beneficence: maximize benefit Justice: distribute burdens fairly

AE vs SAE ET

AE

  • Any untoward occurrence
  • Any severity level

SAE

  • Death or life-threatening
  • Hospitalization or persistent disability
  • Birth defect or important medical event
  • Meets seriousness criteria

AE/SAE Reporting Timeline ET

  • Non-serious AE occurs → Document per protocol schedule
  • SUSAR, fatal/life-threatening → Sponsor reports within 7 days
  • SUSAR, other serious → Sponsor reports within 15 days
  • Any SAE, expected or not → Report to sponsor immediately ( Protocol may exempt named endpoint events )
  • Immediate hazard identified → Remove hazard, then inform sponsor, IRB

Informed Consent Essentials ET

  • Voluntary participation No coercion, withdraw anytime
  • Consent timing Before any study procedure
  • Ongoing process Inform promptly; assess re-consent
  • Required elements Risks, benefits, alternatives, purpose
  • Illiterate participant Oral consent plus impartial witness
  • Assent Child's agreement, age-appropriate
  • LAR Legally acceptable representative consents

GCP's Top Principle ET

  • Participant rights beat science and society
  • Participant welfare first Science interests second

SAE vs SUSAR ET

SAE

  • Serious criteria met
  • May be expected

SUSAR

  • Serious and unexpected
  • Suspected drug causal link
  • Unexpected plus causality

Consent Scenario Picker ET

  • New safety information emerges → Inform promptly; assess re-consent need ( Revised ICF needs IRB approval first )
  • Participant cannot read → Oral consent, impartial witness
  • Pediatric participant enrolled → Obtain assent plus parental consent
  • Participant temporarily incapacitated → Wait, or use LAR
  • New procedure added → Re-consent before performing it

Ethical Principles ET

  • Respect for persons Autonomy and protection
  • Beneficence Maximize benefit, minimize harm
  • Justice Fair distribution of burdens
  • Belmont Report 1979 US ethics foundation
  • Declaration of Helsinki WMA human-subjects ethics statement
  • GCP Principle 1.1 Participant welfare over science

Assent vs Consent ET

Assent

  • Child's agreement to participate
  • Age-appropriate explanation

Consent

  • Parent or LAR permission
  • Legal standing to authorize
  • Child versus guardian

Adverse Event Terms ET

  • AE Any untoward medical occurrence
  • SAE Death, life-threatening, hospitalization, disability, birth defect
  • Important medical event Generally serious; may need intervention
  • SUSAR Serious, unexpected, suspected drug-related
  • ADR Adverse reaction with causal link
  • Unexpected event Nature/severity inconsistent with IB RSI
  • Possibly related Causality can't be excluded

IND vs IDE PR

IND

  • Drug or biologic trials
  • FDA regulatory pathway

IDE

  • Medical device trials
  • Separate FDA pathway
  • Drug versus device

Regulatory Submissions PR

  • IND FDA permission for drug trials
  • IDE FDA permission for device trials
  • NDA/BLA Marketing approval application
  • Clinical hold Regulator suspends the trial
  • Amendment approval IRB clears before implementation

Key ICH Guidelines PR

  • ICH E6 Good Clinical Practice standard
  • ICH E2A Safety data, expedited reporting
  • ICH E8 General trial considerations
  • ICH E9 Statistical principles for trials

Deviation vs Amendment CL

Deviation

  • Unplanned protocol departure
  • Reported after it happens

Amendment

  • Planned protocol change
  • IRB approves it first
  • Reactive versus proactive

GCP Roles CL

  • Investigator Leads trial conduct at site
  • Sponsor Funds, supplies IP, oversees trial
  • CRA/Monitor Sponsor-site link, verifies data
  • IRB/IEC Protects participant rights, safety
  • DSMB Independent safety data reviewer
  • CRC Coordinates day-to-day trial tasks

Audit vs Inspection CL

Audit

  • Sponsor, CRO or institution
  • Independent quality assurance

Inspection

  • Regulator-initiated review
  • Legal enforcement authority
  • Who conducts the review

Documents & Oversight CL

  • Trial master file Collected essential trial documents
  • Delegation log Lists staff, delegated duties
  • SDV CRF checked against source
  • SDR Direct review of source data
  • Audit Independent QA by sponsor/CRO/institution
  • CAPA Corrective and preventive action plan

Which Site Visit Applies ST

  • Before site is chosen → Pre-study qualification visit
  • Before enrollment opens → Site initiation visit (SIV)
  • During active enrollment → Routine monitoring visit
  • Trial activities conclude → Study closeout visit
  • Sponsor reviews compliance → Audit (sponsor-initiated)
  • Regulator reviews compliance → Inspection (authority-led)

Site Visit Lifecycle ST

  • Pre-study visit Qualifies site before selection
  • SIV Trains staff before enrollment
  • Monitoring visit Ongoing compliance and SDV checks
  • Closeout visit Reconciles IP, resolves queries
  • Inspection Regulator-led compliance review

IP Temperature Excursion Steps ST

  • Excursion first noticed → Quarantine product immediately
  • Details unclear → Document time and temperature
  • Sponsor confirms product stable → Resume normal use
  • Sponsor confirms product unstable → Destroy per sponsor instructions

Investigational Product Handling ST

  • IP receipt Document shipment on arrival
  • Storage excursion Quarantine, notify sponsor immediately
  • Dispensing Per investigator, correct dose
  • Accountability log Tracks every dose dispensed
  • Return/destruction Per sponsor's final instructions

ALCOA Plus Nine Traits DA

  • Attributable, legible, contemporaneous, original, accurate, plus four more
  • Complete records always Consistent chronological entries Enduring durable storage Available on demand

SDV vs SDR DA

SDV

  • Compares CRF to source
  • Done during monitoring visits

SDR

  • Reviews source data directly
  • Broader data-quality check
  • Compare versus review

ALCOA+ Data Quality DA

  • Attributable Traceable to the person
  • Legible Readable and permanent
  • Contemporaneous Recorded at time of event
  • Original First recorded, not a copy
  • Accurate Correct and error-free
  • Complete All required data present
  • Consistent Chronologically logical, no gaps
  • Enduring Durable for retention period
  • Available Accessible when needed

Data Tools & Records DA

  • eCRF/EDC Electronic data capture system
  • IWRS/IRT Randomization and IP inventory
  • Data query Flags CRF discrepancy for resolution
  • Source documents Original records behind the CRF
  • Record retention Longest: legal period or sponsor notice

Common Traps

AE Severity vs AE Seriousness

  • Severity means intensity level ≠ Seriousness means SAE criteria met

Audit vs Inspection Source

  • Audit: sponsor, CRO or institution ≠ Inspection comes from regulator

Assent vs Consent Roles

  • Assent is child's agreement ≠ Consent is legal permission

Deviation vs Amendment Timing

  • Deviation happens unplanned ≠ Amendment is pre-approved change

SDV vs SDR Scope

  • SDV checks CRF match ≠ SDR reviews source directly

ICH E6(R2) vs E6(R3)

  • R2 was prior version ≠ R3 tested from July 15, 2026

ECO vs Older DCO Term

  • ECO is current 2024 outline ≠ DCO was the prior name

Last Minute

  • 1. Weights 8-19-13-23-22-15 (six domains)
  • 2. 125 total: 100 scored, 25 pretest
  • 3. 180 minutes total exam time
  • 4. Passing score: scaled 600
  • 5. Consent obtained before any procedure
  • 6. Fatal/life-threatening SUSAR: 7 days (sponsor)
  • 7. Other SUSARs: 15 days (sponsor)
  • 8. Belmont: respect, beneficence, and justice
  • 9. ALCOA+ has nine data-quality traits
  • 10. IRB approves protocol before trial start
  • 11. ICH E6-R3 replaces E6-R2 (2026)
  • 12. Audits: sponsor/CRO/institution; inspections: regulators