Scientific Concepts & Research Design
8%of exam
Study DesignTrial PhasesEndpointsStatistics
Ethical & Participant Safety
19%of exam
Product Development & Regulation
13%of exam
Clinical Trial Operations (GCPs)
23%of exam
Study & Site Management
22%of exam
Site LifecycleIP HandlingEnrollmentSite Budget
Data Management & Informatics
15%of exam
ALCOA+Data ToolsSource DocumentsRecord 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
Safety, then dose, then confirm, then market
Phase I: safetyPhase II: dosingPhase III: confirmsPhase IV: post-market
Study Design Terms
- 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
- 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
Respect, Beneficence, and Justice guide ethics
Respect: honor autonomyBeneficence: maximize benefitJustice: distribute burdens fairly
AE vs SAE
AE
- Any untoward occurrence
- Any severity level
SAE
- Death or life-threatening
- Hospitalization or persistent disability
Meets seriousness criteria
AE/SAE Reporting Timeline
- Non-serious AE occurs→Document per protocol schedule
- SUSAR, fatal/life-threatening→Report within 7 days
- SUSAR, other serious→Report within 15 days
- Expected SAE occurs→Report per protocol schedule
- Immediate hazard identified→Notify sponsor and IRB now
Informed Consent Essentials
- Voluntary participation
- No coercion, withdraw anytime
- Consent timing
- Before any study procedure
- Ongoing process
- Re-consent for new information
- Required elements
- Risks, benefits, alternatives, purpose
- Illiterate participant
- Oral consent plus impartial witness
- Assent
- Child's agreement, age-appropriate
- LAR
- Legally authorized representative signs
GCP's Top Principle
Participant rights beat science and society
Participant welfare firstScience interests second
SAE vs SUSAR
SAE
- Serious criteria met
- May be expected
SUSAR
- Serious and unexpected
- Suspected drug causal link
Unexpected plus causality
Consent Scenario Picker
- New safety information emerges→Update ICF, re-consent participants
- 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
- 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 2
- Participant welfare over science
Assent vs Consent
Assent
- Child's agreement to participate
- Age-appropriate explanation
Consent
- Parent or LAR permission
- Legal standing to authorize
Child versus guardian
Adverse Event Terms
- AE
- Any untoward medical occurrence
- SAE
- Death, life-threatening, hospitalization, disability
- SUSAR
- Serious, unexpected, suspected drug-related
- ADR
- Adverse reaction with causal link
- Unexpected event
- Not in current IB
- Possibly related
- Causality can't be excluded
IND vs IDE
IND
- Drug or biologic trials
- FDA regulatory pathway
IDE
- Medical device trials
- Separate FDA pathway
Drug versus device
Regulatory Submissions
- 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
- 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
Deviation
- Unplanned protocol departure
- Reported after it happens
Amendment
- Planned protocol change
- IRB approves it first
Reactive versus proactive
GCP Roles
- 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
Audit
- Sponsor-initiated review
- Internal quality assurance
Inspection
- Regulator-initiated review
- Legal enforcement authority
Who conducts the review
Documents & Oversight
- 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
- Sponsor-initiated quality review
- CAPA
- Corrective and preventive action plan
Which Site Visit Applies
- 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
- 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
- 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
- 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
Attributable, legible, contemporaneous, original, accurate, plus four more
Complete records alwaysConsistent chronological entriesEnduring durable storageAvailable on demand
SDV vs SDR
SDV
- Compares CRF to source
- Done during monitoring visits
SDR
- Reviews source data directly
- Broader data-quality check
Compare versus review
ALCOA+ Data Quality
- 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
- 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
- Regulatory-defined years, sponsor sets
Common Traps
AE Severity vs AE Seriousness
Severity means intensity level ≠ Seriousness means SAE criteria met
Audit vs Inspection Source
Audit comes from sponsor ≠ 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 active since July 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 SUSAR: report within 7 days
- 7.Other SUSAR: report within 15 days
- 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 are sponsor-led; inspections are regulatory
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