ACRP-CP study guide
ACRP-CP · Work through your exam, one topic at a time.
The ACRP Certified Professional (ACRP-CP®) is a credential awarded by the Association of Clinical Research Professionals to clinical research professionals who pass a standardized certification exam. ACRP describes it as a mark of excellence recognizing demonstrated proficiency across the diverse roles and functions that make up a clinical study team, which makes it a fit for coordinators, monitors, project managers, regulatory and data staff, and others with broad cross-functional exposure rather than deep specialization in a single job title. The ACRP-CP study guide has 8 sections and about 2,736 words.
01Scientific Concepts and Research Design
A trial exists to answer a question, so the first examinable concepts are the hypothesis and the endpoints that test it. A primary endpoint is the single pre-specified measure that drives sample size and the statistical conclusion; secondary endpoints support or explore, and exploratory endpoints generate hypotheses rather than confirm them.
359 words, about 2 min02Ethical and Participant Safety Considerations
Ethics content clusters around three frameworks: the Belmont principles (respect for persons, beneficence, justice), the Declaration of Helsinki, and the GCP and regional regulations that operationalize them. For each, move from principle to practice: respect for persons becomes informed consent plus additional protections for those with diminished autonomy; beneficence becomes favourable risk–benefit assessment and ongoing safety monitoring; justice becomes fair subject selection and fair distribution of burdens and benefits.
343 words, about 2 min03Medicines Development and Regulation
Regulatory questions reward a clean map of the development timeline. Preclinical work (pharmacology, toxicology, GLP safety studies) supports an IND in the US or a CTA in the EU, which permits human dosing.
356 words, about 2 min04Clinical Trials Operations (GCP and ICH)
ICH E6 defines GCP as a standard for designing, conducting, recording and reporting trials involving human subjects, and operational questions test who owns what. The sponsor initiates, manages and finances the trial; selects investigators; provides the investigator brochure; ensures monitoring; handles regulatory safety reporting; and owns the trial master file.
321 words, about 2 min05Study and Site Management
Site management spans feasibility and selection through activation, conduct and close-out. At feasibility you assess patient pool, competing trials, equipment, staffing and regulatory turnaround; at selection you confirm the site can recruit to target and comply with the protocol.
343 words, about 2 min06Data Management and Informatics
Data management questions test the path a data point travels: source document, entry into the eCRF, validation, query, resolution, coding, and lock. Know the standards: CDASH governs what is collected at the site, SDTM governs how it is submitted, and controlled terminology plus MedDRA and WHO Drug dictionaries standardize coding.
333 words, about 2 min07Leadership and Professionalism
Leadership content is less about management theory than about behaviour under pressure: accountability, integrity, conflict-of-interest management, mentoring, and willingness to escalate. A research leader is expected to model GCP compliance, make decisions transparently, delegate with clear authority and documented training, and build an environment where staff report errors without fear.
333 words, about 2 min08Communication and Teamwork
Communication in trials is a planned, documented activity rather than a courtesy. A communication plan maps stakeholders - participants, site staff, monitors, sponsor functions, vendors, regulators, IRB/IEC - to what they need, when, through which channel, and who owns delivery.
348 words, about 2 min