Study guide
ACRP-CP study guide
Read a lesson, then practice the ideas you want to remember.
Lessons
- CRO Oversight, Vendor Management & Transfer
- The Eleven ICH E6 Principles of GCP & Guidel
- Sponsor & Investigator Responsibilities and
- Staff Training, Qualifications & Delegation
- Emergency Unblinding Protocols & Subject Saf
- Investigational Product Lifecycle, Labeling,
- IP Shipping, Receipt, Temperature Monitoring
- IP Storage, Dispensing, Accountability Logs
- Investigator's Brochure, Instructions for Us
- Protocol Submission, Approval & Amendment Pr
- Regulatory Reporting Requirements Before and
- Stakeholders, Regulatory Institutions & Glob
- Computerised Systems, Data Governance & Audi
- Data Validation, Edit Checks, Discrepancy /
- Electronic Data Capture, eCRF Design & Clini
- Medical Coding, SAE Reconciliation, Data Tra
- Phases of Clinical Research & Translational
- Endpoints, Sample Size & Biostatistical Conc
- Interim Analyses, DSMB/IDMC Oversight & Effi
- Randomization Schemes, Stratification, Blind
- Study Designs: Parallel, Crossover, Factoria
- Trial Registration, Results Transparency & C
- Confidentiality, Privacy & Protection of Par
- Essential Records Before, During and After t
- Source Documentation, ALCOAC Principles & Me
- Trial Master File and Investigator Site File
- Quality Audits, Regulatory Inspections, Non-
- Monitoring Visit Types: Site Selection, SIV,
- Risk-Based Quality Management & Quality Mana
- Risk-Based Monitoring, Centralized Monitorin
- Biological Samples & Hazardous Goods: Collec
- Contractual Agreements: Clinical Trial Agree
- Protocol Review, Operational Feasibility & I
- Site Facilities, Equipment Maintenance, Cali
- Site Feasibility Assessment, Capability Anal
- Site Initiation Preparation, System Access &
- Managing Lost to Follow-Up, Subject Withdraw
- Subject Recruitment Strategies, Advertising
- Subject Retention, Compliance, Visit Schedul
- Screening, Eligibility Verification & Inclus
- Protocol Compliance, Waivers vs. Violations
- Record Retention, Archiving Requirements & P
- Investigational Site Close-Out Activities &
- Conflict of Interest, Research Misconduct &
- Ethical Principles: Beneficence, Non-Malefic
- Historical Milestones: Nuremberg Code, Belmo
- Vulnerable Populations — Free Study Guide 2026
- Assent in Minors & Legally Acceptable Repres
- Informed Consent Elements, Process & Ongoing
- IRB/IEC Composition, Functions, Review Types
- Adverse Events vs. Adverse Drug Reactions &
- Causality Assessment, Expectedness, Referenc
- Expedited Reporting Timelines & Periodic Saf