CCRA case studies
CCRA · Put your knowledge to work in context.
The CCRA® - Certified Clinical Research Associate - credential is one of the certification programs offered by the Association of Clinical Research Professionals (ACRP), listed alongside the ACRP-CP®, CCRC®, CPI®, ACRP-MDP®, and ACRP-PM® programs. It is aimed at professionals who monitor and oversee clinical trials at investigator sites: verifying that study conduct, data, and documentation meet the protocol, Good Clinical Practice expectations, and applicable regulatory requirements. ACRP describes its certification as the most widely recognized benchmark of excellence in clinical research competency, and states that certified professionals report increased job responsibility, more employment and advancement opportunities, and recognition including promotions, bonuses, and salary increases. The exam is expected to test the working knowledge a monitor applies daily: site qualification and initiation, routine and close-out monitoring, source document and case report form verification, investigational product accountability, adverse event and protocol deviation handling, informed consent review, essential document maintenance, and the regulations and ethical frameworks that govern human subjects research. The CCRA case studies are 5 cases and about 2,927 words.
1Temperature Excursion in a −20°C Investigational Product Freezer
During a routine monitoring visit at Site 104 for a Phase II double-blind study, you review the investigational product (IP) freezer data logger. The protocol requires storage at −20°C ±5°C.
650 words, about 3 min2Outdated Consent Form and Questionable Legal Authorization
At Site 312, the central IRB approved informed consent form (ICF) version 4.0 on 3 March. Version 4.0 added a new risk about hypersensitivity reactions and a revised compensation statement.
580 words, about 3 min3A Site With Persistent Under-Enrollment and a Disengaged PI
Site 207 has a 12-month enrollment target of 24 subjects in a Phase III cardiovascular outcomes study. After 9 months, it has enrolled 3.
571 words, about 3 min4Unsupported Eligibility Value in Source and EDC
During source data verification for Subject 012-005 in a Phase I/II oncology trial, you find that the protocol requires a screening eGFR ≥50 mL/min/1.73 m². The central laboratory printout in the source file reports 47.
572 words, about 3 min5Wrong Kit Dispensed After Randomization in a Blinded Trial
At Site 045, a double-blind placebo-controlled trial uses an interactive web response system (IWRS) for randomization and kit assignment. At Visit 2, Subject 045-011 was randomized to Arm B, and IWRS assigned kit 045-011-0032.
554 words, about 3 min