Research Study Start-Up
40%of exam
Informed ConsentIRB ApprovalIND/IDEProtocol DevelopmentSite Selection
Research Study Implementation
50%of exam
Adverse EventsMonitoringProtocol ComplianceIP AccountabilityData Management
Research Study Closure
10%of exam
Close-Out VisitRecord RetentionArchivingFinal Reports
Quick Facts
- Exam
- CCRP
- Credential
- Clinical Research Professional
- Body
- SOCRA
- Questions
- 130 (100 scored + 30 pilot)
- Time
- 4 hours (240 min)
- Pass Score
- 71/100 (71%)
- Format
- Multiple choice, Prometric/paper
- Level
- Professional certification
- Blueprint
- ICH E6(R3), Jan 2026
Belmont Report Principles
Respect + Beneficence + Justice = RBJ
Respect: honor autonomyBeneficence: maximize benefitJustice: fair subject selection
IRB vs FDA Oversight
IRB
- Local ethics review
- Approves protocol and consent
- Continuing annual review
FDA
- Federal regulator
- Reviews IND and IDE
- Inspects sites nationally
Local ethics vs federal
IRB Review Type Picker
- Minimal risk, listed category→Expedited review(No convened meeting)
- Greater than minimal risk→Full board review(Convened meeting vote)
- No human subjects research→Exempt determination(IRB still decides)
- Ongoing approved study→Continuing review(At least annually)
- Significant risk device→Full IDE process(21 CFR 812)
- Nonsignificant risk device→Abbreviated IDE(IRB approval only)
- Vulnerable population enrolled→Additional safeguards(Subpart D/E rules)
- Single-patient emergency use→IRB chair approval(Exception pathway)
Ethical Foundations
- Nuremberg Code (1947)
- Voluntary consent essential
- Declaration of Helsinki (1964)
- Physician ethics guidance
- Belmont Report (1979)
- Respect, beneficence, justice
- Common Rule
- 45 CFR 46 baseline
- ICH GCP E6
- Global quality standard
- Respect for Persons
- Autonomy, protect vulnerable
- Beneficence
- Maximize benefit, minimize harm
- Justice (Belmont)
- Fair subject selection
Key CFR Parts
11=eRecords | 50=Consent | 56=IRB | 312=IND | 812=IDE
11: eRecords50: informed consent56: IRB rules312: IND drugs812: IDE devices
IND vs IDE Pathway
IND
- Drug or biologic
- 21 CFR 312
- Sponsor files with FDA
IDE
- Medical device
- 21 CFR 812
- Significant risk needs IDE
Drug vs device pathway
Key CFR Parts
- 21 CFR 11
- Electronic records, signatures
- 21 CFR 50
- Informed consent rules
- 21 CFR 54
- Financial disclosure by investigators
- 21 CFR 56
- IRB composition, function
- 21 CFR 312
- IND application requirements
- 21 CFR 812
- IDE application for devices
- 45 CFR 46
- Common Rule protections
- 42 CFR 11
- ClinicalTrials.gov results reporting
8 Consent Elements
Purpose, risks, benefits, alternatives, confidentiality, injury, contacts, voluntary
Purpose: study explained clearlyRisks: foreseeable harms listedVoluntary: refusal, no penalty
Full Board vs Expedited
Full Board
- Convened meeting required
- Majority vote needed
- Greater than minimal risk
Expedited
- One or more reviewers
- No convened meeting
- Minimal risk category only
Risk level sets pathway
Consent Elements (50.25)
- Purpose/procedures
- Study nature explained
- Risks
- Reasonably foreseeable risks listed
- Benefits
- Expected benefits described
- Alternatives
- Other treatment options noted
- Confidentiality
- Records may be inspected
- Compensation for injury
- Available treatment explained
- Contacts
- Whom to call, questions
- Voluntary participation
- Refusal allowed, no penalty
SOCRA CCRP vs ACRP
SOCRA CCRP
- One comprehensive credential
- Tests US regs plus GCP
- Renews every 3 years
ACRP CCRC/CCRA
- Role-specific credentials
- Tests ICH GCP only
- Renews every 2 years
One exam vs role-specific
IRB Requirements (56)
- Minimum members
- 5 members required
- Composition rule
- 1 scientific, 1 nonscientific
- Unaffiliated member
- At least one required
- Quorum
- Majority present, one nonscientific
- Full board review
- Convened meeting, majority vote
- Expedited review
- Minimal risk categories only
- Continuing review
- At least annually required
- Exempt research
- No ongoing IRB review
IND vs IDE Basics
- IND
- New drug, Part 312
- IDE
- Device study, Part 812
- Sponsor
- Files IND or IDE
- 30-day review
- FDA default IND wait
- Significant risk device
- Needs IDE plus IRB
- Nonsignificant risk device
- IRB approval only needed
- Form 1571
- IND application form
- Form 1572
- Statement of Investigator form
SAE Reporting Timelines
7 days fatal, 15 serious, 24h sponsor
7d: fatal or life-threatening15d: other serious SUSAR24h: investigator notifies sponsor
Deviation vs Violation
Deviation
- Minor unplanned departure
- No harm to subject
- Documented, not always reported
Violation
- Serious or willful departure
- Harms rights or data
- Reportable to IRB, sponsor
Minor vs serious departure
Safety Reporting Timeline Picker
- Fatal or life-threatening SUSAR→Report in 7 days(To FDA)
- Other serious unexpected reaction→Report in 15 days(To FDA)
- Any SAE at site→Notify sponsor in 24h(Investigator duty)
- New safety information found→Update investigator brochure(Sponsor duty)
- Unanticipated problem occurs→Report to IRB promptly(Per IRB policy)
- Annual IND status due→Submit yearly report(Sponsor to FDA)
Sponsor and Investigator Duties
- Sponsor
- Selects, monitors investigators
- Investigator
- Conducts trial per protocol
- Form 1572
- Investigator's regulatory commitments
- Delegation log
- Assigns and tracks tasks
- Sub-investigator
- Delegated trial responsibilities
- Financial disclosure
- Required under 21 CFR 54
- Training log
- Documents staff qualifications
- Site file
- Essential documents binder
SAE vs Unanticipated Problem
SAE
- Death, hospitalization, or disability
- Defined by 312.32
- Always documented at site
Unanticipated Problem
- Unexpected and related risk
- Increases risk to subjects
- Reportable to IRB
FDA term vs IRB term
AE/SAE Reporting Timelines
- SAE definition
- Death, hospitalization, or disability
- Fatal/life-threatening SUSAR
- Report within 7 days
- Other serious SUSAR
- Report within 15 days
- Investigator to sponsor
- Report within 24 hours
- IND safety report
- 15 days to FDA
- Unanticipated problem
- Report to IRB promptly
- Annual safety report
- Yearly IND summary to FDA
- Expectedness
- Judged against Investigator's Brochure
Monitoring and Data Management
- SDV
- Source data verification
- On-site monitoring
- In-person site visits
- Remote monitoring
- Off-site data review
- Risk-based monitoring
- Focuses on critical data
- CRF
- Case report form
- Query
- Data discrepancy resolution
- Source document
- Original data record
- Audit trail
- Electronic change history
Investigational Product Accountability
- Drug accountability log
- Tracks IP dispensing, return
- Chain of custody
- Receipt through disposition tracking
- Blinding
- Concealed treatment assignment
- Randomization
- Unbiased group assignment
- Protocol deviation
- Minor unplanned departure
- Protocol violation
- Serious departure harming subjects
- CAPA
- Corrective and preventive action
- Temperature excursion
- Storage condition breach
Study Document Picker
- Investigator's regulatory commitments needed→Form 1572(Statement of Investigator)
- New drug application filing→Form 1571(IND application)
- Subject permission needed→Informed consent form(21 CFR 50)
- Task delegation needed→Delegation log(Site file)
- IP shipment tracking needed→Drug accountability log(Chain of custody)
- Final study summary needed→Closure report(To IRB/sponsor)
Closure and Archiving
- Close-out visit
- Final monitoring visit
- Record retention
- 2 years post-approval minimum
- Essential documents
- Trial master file
- IP disposition
- Return or destroy product
- Final IRB report
- Study completion notice
- ClinicalTrials.gov results
- Due within 1 year
- IND withdrawal
- Sponsor closes the IND
- Archiving
- Long-term secure storage
Common Traps
Deviation vs Violation
Deviation: minor, unplanned departure ≠ Violation: harms rights or data
SAE vs Unanticipated Problem
SAE: defined by 312.32 ≠ UP: reportable to IRB
IRB Approval vs FDA Review
IRB approves the study locally ≠ FDA reviews IND and IDE
Investigator vs Sponsor Duties
Investigator conducts the actual trial ≠ Sponsor selects and monitors sites
Expedited vs Full Board Review
Expedited handles minimal risk only ≠ Full board handles greater risk
SOCRA CCRP vs Cardiac Rehab CCRP
SOCRA CCRP: clinical research role ≠ AACVPR CCRP: cardiac rehab role
Consent vs Assent for Minors
Consent: adult subject agreement ≠ Assent: minor's affirmative agreement
Last Minute
- 1.Weights: 40/50/10 by domain
- 2.130 total questions, 100 scored
- 3.Pass = 71 of 100 correct
- 4.4-hour time limit total
- 5.IRB needs minimum 5 members
- 6.Consent form has 8 elements
- 7.Fatal SAE: report in 7 days
- 8.Other serious SAE: 15 days
- 9.Investigator notifies sponsor within 24h
- 10.1572 = Statement of Investigator
- 11.IND = drugs; IDE = devices
- 12.SOCRA tests US regs plus GCP
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