SOCRA Study Guide 2026
Everything you need to pass the SOCRA exam in one place: the exam format, every topic to study, real practice questions with explanations, flashcards, and full-length practice tests. Free, no sign-up needed.
📋 SOCRA Exam Format at a Glance
📚 SOCRA Topics to Study (79)
✍️ Sample SOCRA Questions & Answers
1. Which of the following is a primary responsibility of the Principal Investigator regarding adverse event management?
The Principal Investigator is responsible for ensuring all adverse events (AEs) are properly documented in the source records and reported to the sponsor. The specific timelines and methods for reporting both serious and non-serious AEs are dictated by the clinical trial protocol. Investigators report SAEs to the sponsor, not directly to the FDA.
2. A site's audit reveals that informed consent forms for 5 subjects were signed after the subjects had already undergone screening procedures. This finding is BEST classified as:
Obtaining consent after procedures begin violates the fundamental GCP principle of informed consent prior to any trial-related activities and constitutes a serious violation.
3. Source data in a clinical trial, as defined by ICH GCP, must be ALCOA-C. What does the 'C' in this acronym stand for?
The acronym ALCOA-C (or ALCOA+) refers to the standards for high-quality data. It stands for Attributable, Legible, Contemporaneous, Original, Accurate, and Complete. 'Complete' means that the data includes all pertinent observations for that subject, without missing information.
4. During a trial, who is primarily responsible for ensuring that monitoring is performed?
ICH E6(R2) and 21 CFR Part 312 place primary responsibility on the sponsor to conduct adequate monitoring to ensure data quality and subject protection.
5. What is the minimum number of IRB members?
According to FDA regulations (21 CFR 56.107), an Institutional Review Board (IRB) must have at least five members. This minimum number ensures a diverse range of expertise and perspectives are present during the review of research protocols. A larger, diverse committee helps to provide a thorough and unbiased ethical and scientific review of studies involving human subjects.
6. During an FDA inspection, an investigator is found to have multiple unreported protocol deviations. What is the MOST likely consequence?
Failure to report protocol deviations can result in FDA 483 inspectional observations, Warning Letters, or investigator disqualification proceedings under 21 CFR Part 312.