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CCRP Cheat Sheet

Practice this exam

Research Study Start-Up

  • 40% of exam
  • Informed Consent IRB Approval IND/IDE Protocol Development Site Selection

Research Study Implementation

  • 50% of exam
  • Adverse Events Monitoring Protocol Compliance IP Accountability Data Management

Research Study Closure

  • 10% of exam
  • Close-Out Visit Record Retention Archiving Final 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 MCQ; test center or remote
  • Level Professional certification
  • Blueprint ICH E6(R3), Jan 2026

Belmont Report Principles RE

  • Respect + Beneficence + Justice = RBJ
  • Respect: honor autonomy Beneficence: maximize benefit Justice: fair subject selection

IRB vs FDA Oversight RE

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 RE

  • 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 RE

  • 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 RE

  • 11=eRecords | 50=Consent | 56=IRB | 312=IND | 812=IDE
  • 11: eRecords 50: informed consent 56: IRB rules 312: IND drugs 812: IDE devices

IND vs IDE Pathway RE

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 RE

  • 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 RE

  • Purpose, risks, benefits, alternatives, confidentiality, injury, contacts, voluntary
  • Purpose: study explained clearly Risks: foreseeable harms listed Voluntary: refusal, no penalty

Full Board vs Expedited RE

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) RE

  • 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 RE

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) RE

  • 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 RE

  • 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 RE

  • 7 days fatal, 15 serious, 24h sponsor
  • 7d: fatal or life-threatening 15d: other serious SUSAR 24h: investigator notifies sponsor

Deviation vs Violation RE

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 RE

  • 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 RE

  • 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 RE

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 RE

  • 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 RE

  • 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 RE

  • 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 RE

  • 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 RE

  • 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

SOCRA CCRP Certified Clinical Research Professional

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