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 key facts

  • The SOCRA CCRP exam has 130 multiple-choice questions, of which 100 are scored and 30 are unscored beta questions. Source
  • Candidates have 4 hours to complete the SOCRA CCRP exam. Source
  • To pass the SOCRA CCRP exam, candidates must correctly answer 71 of the 100 scored questions. Source
  • SOCRA CCRP candidates get up to 3 retests, must wait 14 days after an unsuccessful attempt, and must show proof of 6 hours of GCP education before a 4th attempt. Source
  • SOCRA CCRP certification must be recertified every three years. Source
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📋 SOCRA Exam Format at a Glance

130
Questions
240 min
Time Limit
71.00%
Passing Score

📚 SOCRA Topics to Study (60)

✍️ Sample SOCRA Questions & Answers

1. Which of the following is a primary responsibility of the Principal Investigator regarding adverse event management?
✓ To document all adverse events and report them to the sponsor according to the protocol-specified timelines and procedures.

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. Source data in a clinical trial, as defined by ICH GCP, must be ALCOA-C. What does the 'C' in this acronym stand for?
✓ Complete

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.

3. What is an FDA Form 483?
✓ A written list of inspectional observations issued to a facility at the close of an FDA inspection

FDA Form 483 is issued by an FDA investigator at the conclusion of a facility inspection and documents conditions or practices observed that may constitute violations of applicable regulations. The recipient is expected to respond with a corrective action plan.

4. What is the minimum number of IRB members?
✓ 5

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.

5. Which document specifically tracks the movement of investigational product from the manufacturer to the investigator site?
✓ Chain of Custody / Shipping manifest

The chain of custody or shipping manifest documents the transfer of IP from origin to destination, ensuring accountability at every step.

6. A non-biometric electronic signature must use at least:
✓ Two distinct identification components, such as a user ID and a password

Section 11.200(a) requires non-biometric e-signatures to use at least two distinct identification components, such as an ID code and a password.

🎯 Free SOCRA Practice Tests

📖 SOCRA Guides & Articles

Your SOCRA Study Path
1. Learn with Flashcards → 2. Drill Practice Tests → 3. Take the Full Exam Simulation

What Practice Test Geeks adds beyond an AI chat for SOCRA

An AI chatbot can quiz you, but it can't reproduce the exam conditions or keep your record. Here you get:

  • A timed, full-length SOCRA mock exam — 130 questions in 240 minutes with a 71% pass mark, modeled on the official exam's question count and time limit, followed by a score report broken down by exam domain.
  • A fixed SOCRA question bank: the same test every attempt, so your score is comparable from one try to the next instead of changing with every regenerated quiz.
  • Progress saved on your device: completed tests, scores and missed questions stay in My Progress, so you can retake only what you got wrong.
  • A printable SOCRA cheat sheet you can print or save as a PDF.
  • SOCRA flashcards built from the same question bank.
  • Free SOCRA practice tests with the correct answer shown after each question.
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How this page was made: written with AI tools and published by Nathan Beja, founder of Practice Test Geeks, who is responsible for its content. Exam facts are checked against the official sources listed below. Not reviewed by a subject-matter expert. Editorial policy

Sources & references

Exam facts on this page (fees, format, dates, passing scores) are checked against these official sources; the date is our last check. Editorial policy

  1. socra.org — Renewal, score validity, retake fee, retake policy, score release, test delivery, registration deadline, test dates, time limit, exam format · verified Oct 2026