• 80 questions

SOCRA Practice Test

Unofficial exam prep questions for SOCRA's Certified Clinical Research Professional exam, in the three content areas of its outline.

Which phase of a drug investigation generally includes 20 to 80 subjects?

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Exam mode: 50 questions, no time limit, 36 right to pass (71%).

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Unofficial practice questions, not affiliated with SOCRA (the Society of Clinical Research Associates). Bank checked October 9, 2026.

The real exam, as SOCRA describes it

Questions
130
Fee
US$510 for current SOCRA members, US$565 for non-members.
Scored questions
100. The other 30 are unscored beta test questions and are not identified.
Pass mark
71 of the 100 scored questions.
Content areas
Start-up 40%, implementation 50%, closure 10%.

Checked October 9, 2026 against SOCRA, CCRP Exam Outline. Rules change, so confirm with the agency itself before your test.

SOCRA's own exam outline page

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All 80 questions

Research study start-up 32

  • A device sponsor obtains a signed agreement from each investigator under 21 CFR 812.43(c). Which of these must it include? 21 CFR 812.43(c). Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • A draft consent form says the subject "gives up any claim against the sponsor for negligence." What does 21 CFR 50.20 say? 21 CFR 50.20. Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • A hospital's officials want a study that the IRB disapproved to go ahead. What does 21 CFR 56.112 say about them? 21 CFR 56.112. Outline: SOCRA CCRP exam outline, 1c Obtain research study approval from necessary stakeholders.
  • A sponsor is choosing sites. By ICH E6(R3) section 3.7.1, what should each investigator demonstrate besides being qualified? ICH E6(R3), Annex 1, section 3.7.1. Outline: SOCRA CCRP exam outline, 1e Select research study sites.
  • A sponsor presents a device study to an IRB as non-significant risk. The IRB decides the device is significant risk. What must the IRB do? 21 CFR 812.66. Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
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Research study start-up, continued

  • A sponsor submits an IND and FDA does not place it on clinical hold. When does the IND go into effect? 21 CFR 312.40(b). Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
  • A test article is used once in a life-threatening emergency before the IRB can meet. By when must the use be reported to the IRB? 21 CFR 56.104(c). Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
  • An electronic data system falls under 21 CFR Part 11. What must happen when a user changes a recorded value? 21 CFR 11.10(e). Outline: SOCRA CCRP exam outline, 1d Obtain research study product, related materials, equipment, tools and aids.
  • An investigator holds stock in the publicly held sponsor of a covered clinical study. Above what value is it a significant equity interest under 21 CFR 54.2(b)? 21 CFR 54.2(b). Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • An IRB disapproves a study. What must its written notice include, under 21 CFR 56.109(e)? 21 CFR 56.109(e). Outline: SOCRA CCRP exam outline, 1c Obtain research study approval from necessary stakeholders.
  • An IRB of nine meets with five members present, all of them scientists. May it vote on a new study under 21 CFR 56.108(c)? 21 CFR 56.108(c). Outline: SOCRA CCRP exam outline, 1g Evaluate research study's compliance with relevant laws.
  • By 42 CFR 11.24(a), how soon after the first human subject is enrolled must an applicable clinical trial be registered at ClinicalTrials.gov? 42 CFR 11.24(a). Outline: SOCRA CCRP exam outline, 1g Evaluate research study's compliance with relevant laws.
  • By ICH E6(R3) section 2.3.2, what trial-related training should a person assisting in a trial receive? ICH E6(R3), Annex 1, section 2.3.2. Outline: SOCRA CCRP exam outline, 1f Train research study staff members.
  • By the Declaration of Helsinki, the purposes of medical research can never take precedence over what? World Medical Association, Declaration of Helsinki (as amended October 2024), General Principles. Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
  • For financial disclosure under 21 CFR 54.2(d), whose interests are counted with the clinical investigator's own? 21 CFR 54.2(d). Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • For how long after a study is completed must an investigator promptly update the financial information given to the sponsor (21 CFR 312.53(c)(4))? 21 CFR 312.53(c)(4). Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • How does 45 CFR 46.102 define minimal risk? 45 CFR 46.102(j). Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
  • How must IRB minutes record a vote, under 21 CFR 56.115(a)(2)? 21 CFR 56.115(a)(2). Outline: SOCRA CCRP exam outline, 1g Evaluate research study's compliance with relevant laws.
  • How often should an Investigator's Brochure be reviewed, by ICH E6(R3) Appendix A? ICH E6(R3), Appendix A, section A.1.1. Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • ICH E6(R3) Appendix B asks the protocol to describe the measures taken to minimise or avoid bias. Which two does it name? ICH E6(R3), Appendix B, section B.4.3. Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
  • In expedited review under 21 CFR 56.110(b), what may the reviewer not do? 21 CFR 56.110(b). Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
  • On which form does an applicant disclose a clinical investigator's financial interests and arrangements under 21 CFR 54.4? 21 CFR 54.4(a). Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • What does an independent data monitoring committee do, by the ICH E6(R3) glossary? ICH E6(R3), Glossary, Independent Data Monitoring Committee (IDMC). Outline: SOCRA CCRP exam outline, 1g Evaluate research study's compliance with relevant laws.
  • What is the smallest number of members an IRB may have under 21 CFR 56.107(a)? 21 CFR 56.107(a). Outline: SOCRA CCRP exam outline, 1g Evaluate research study's compliance with relevant laws.
  • When an investigator delegates trial-related activities, what does ICH E6(R3) section 2.3.3 say should be kept? ICH E6(R3), Annex 1, section 2.3.3. Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • Which consent forms must carry the ClinicalTrials.gov statement of 21 CFR 50.25(c)? 21 CFR 50.25(c). Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • Which document must a sponsor obtain from an investigator before the investigator begins to take part in an IND study? 21 CFR 312.53(c)(1). Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • Which of these is an additional element of informed consent, given when appropriate, and not one of the basic elements of 21 CFR 50.25(a)? 21 CFR 50.25(a) and (b). Outline: SOCRA CCRP exam outline, 1b Create or obtain research study documents.
  • Which of these makes an investigational device a significant risk device under 21 CFR 812.3(m)? 21 CFR 812.3(m). Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
  • Which phase of a drug investigation generally includes 20 to 80 subjects? 21 CFR 312.21(a). Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
  • Which statement is the first point of the Nuremberg Code? The Nuremberg Code, point 1, as printed by the HHS Office of Research Integrity. Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.
  • Which three basic ethical principles does the Belmont Report set out? The Belmont Report (1979), Part B, Basic Ethical Principles, read in the Wikisource copy. Outline: SOCRA CCRP exam outline, 1a Coordinate the development of initial research study protocol.

Research study implementation 40

  • A 9-year-old says nothing when asked to join a study. Is that assent under 21 CFR 50.3(n)? 21 CFR 50.3(n). Outline: SOCRA CCRP exam outline, 2e Manage subjects.
  • A coordinator hands a patient a consent form in the pre-operative room and asks for a signature before surgery starts in ten minutes. Which rule of 21 CFR 50.20 is at risk? 21 CFR 50.20. Outline: SOCRA CCRP exam outline, 2e Manage subjects.
  • A coordinator sees a participant's treatment assignment by accident. By ICH E6(R3), what should the investigator do? ICH E6(R3), Annex 1, section 2.11, Randomisation Procedures and Unblinding. Outline: SOCRA CCRP exam outline, 2c Manage research study product.
  • A device sponsor determines that an unanticipated adverse device effect presents an unreasonable risk to subjects. How soon must it end the affected investigations (21 CFR 812.46(b)(2))? 21 CFR 812.46(b)(2). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • A participant cannot read. By ICH E6(R3) section 2.8.9, for how much of the informed consent discussion should an impartial witness be present? ICH E6(R3), Annex 1, section 2.8.9. Outline: SOCRA CCRP exam outline, 2e Manage subjects.
  • A site's recruitment flyer calls the investigational drug "safe and effective." What does 21 CFR 312.7(a) say? 21 CFR 312.7(a). Outline: SOCRA CCRP exam outline, 2c Manage research study product.
  • A sponsor determines that a serious and unexpected suspected adverse reaction must be reported. How long does it have to send the IND safety report (21 CFR 312.32(c)(1))? 21 CFR 312.32(c)(1). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • A sponsor first receives word of an unexpected fatal suspected adverse reaction. How soon must it notify FDA under 21 CFR 312.32(c)(2)? 21 CFR 312.32(c)(2). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • A subject on study drug is hospitalized after a car crash that the investigator thinks has nothing to do with the drug. What does 21 CFR 312.64(b) require? 21 CFR 312.64(b). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • Against which document is an adverse event judged "unexpected" under 21 CFR 312.32(a)? 21 CFR 312.32(a). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • An investigational drug is a controlled substance. How must the investigator store it, by 21 CFR 312.69? 21 CFR 312.69. Outline: SOCRA CCRP exam outline, 2c Manage research study product.
  • An investigator first learns of an unanticipated adverse device effect. What is the latest the report may reach the sponsor and reviewing IRB (21 CFR 812.150(a)(1))? 21 CFR 812.150(a)(1). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • An investigator uses a test article without consent in a life-threatening emergency under 21 CFR 50.23(a). Who must also certify the situation in writing? 21 CFR 50.23(a). Outline: SOCRA CCRP exam outline, 2g Communicate with research study stakeholders.
  • An IRB reviews research on prisoners under 45 CFR Part 46, Subpart C. What must its membership include? 45 CFR 46.304. Outline: SOCRA CCRP exam outline, 2e Manage subjects.
  • An IRB terminates its approval of a study after unexpected serious harm to subjects. To whom must it promptly report this, under 21 CFR 56.113? 21 CFR 56.113. Outline: SOCRA CCRP exam outline, 2g Communicate with research study stakeholders.
  • By 21 CFR 312.66, what must an investigator promptly report to the IRB? 21 CFR 312.66. Outline: SOCRA CCRP exam outline, 2a Execute research study.
  • By ICH E2A, after first notifying regulators of a fatal unexpected reaction, how long does the sponsor have to send as complete a report as possible? ICH E2A, section III.B.1, Fatal or Life-Threatening Unexpected ADRs. Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • By ICH E6(R3) section 2.10.1, with whom does responsibility for managing investigational product at the site rest? ICH E6(R3), Annex 1, section 2.10.1. Outline: SOCRA CCRP exam outline, 2c Manage research study product.
  • By ICH E6(R3) section 2.4.2, which of these should have a dated IRB/IEC approval before a trial begins? ICH E6(R3), Annex 1, section 2.4.2. Outline: SOCRA CCRP exam outline, 2e Manage subjects.
  • By ICH E6(R3) section 2.5.3, which protocol deviations should the investigator document? ICH E6(R3), Annex 1, section 2.5.3. Outline: SOCRA CCRP exam outline, 2a Execute research study.
  • By the ICH E6(R3) glossary, what is an audit? ICH E6(R3), Glossary, Audit. Outline: SOCRA CCRP exam outline, 2h Perform or participate in a research study audit.
  • By the ICH E6(R3) glossary, what makes a copy of a record a certified copy? ICH E6(R3), Glossary, Certified Copy. Outline: SOCRA CCRP exam outline, 2f Maintain the research study.
  • Consent is documented with a short form under 21 CFR 50.27(b)(2). Who signs the written summary of what was said? 21 CFR 50.27(b)(2). Outline: SOCRA CCRP exam outline, 2e Manage subjects.
  • During an FDA inspection of study records under 21 CFR 312.68, when must an investigator divulge subject names? 21 CFR 312.68. Outline: SOCRA CCRP exam outline, 2b Assure regulatory compliance.
  • How must informed consent begin under 45 CFR 46.116(a)(5)(i)? 45 CFR 46.116(a)(5)(i). Outline: SOCRA CCRP exam outline, 2e Manage subjects.
  • How often must an IRB conduct continuing review of approved research under 21 CFR 56.109(f)? 21 CFR 56.109(f). Outline: SOCRA CCRP exam outline, 2a Execute research study.
  • ICH E6(R3) section 2.12.2 lists qualities of source records. Which set is from that list? ICH E6(R3), Annex 1, section 2.12.2. Outline: SOCRA CCRP exam outline, 2f Maintain the research study.
  • In ICH E2A, what does the word "severe" describe about an adverse event? ICH E2A, section II.B, Serious Adverse Event or Adverse Drug Reaction. Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • On what grounds may FDA begin to disqualify a clinical investigator under 21 CFR 312.70(a)? 21 CFR 312.70(a). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • To whom may an investigator give an investigational drug, by 21 CFR 312.61? 21 CFR 312.61. Outline: SOCRA CCRP exam outline, 2c Manage research study product.
  • Under 21 CFR 50.25(a)(5), the confidentiality statement in a consent form must note the possibility of what? 21 CFR 50.25(a)(5). Outline: SOCRA CCRP exam outline, 2b Assure regulatory compliance.
  • What is a "suspected adverse reaction" in 21 CFR 312.32(a)? 21 CFR 312.32(a). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • What must each subject's case history document about informed consent, under 21 CFR 312.62(b)? 21 CFR 312.62(b). Outline: SOCRA CCRP exam outline, 2e Manage subjects.
  • When is the annual report on an IND due to FDA, by 21 CFR 312.33? 21 CFR 312.33. Outline: SOCRA CCRP exam outline, 2g Communicate with research study stakeholders.
  • Which FDA form does 21 CFR 312.32(c)(1)(v) name for submitting an IND safety report? 21 CFR 312.32(c)(1)(v). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • Which of these is a condition for research involving pregnant women under 45 CFR 46.204? 45 CFR 46.204(h) and (i). Outline: SOCRA CCRP exam outline, 2e Manage subjects.
  • Which outcome makes an adverse event "serious" under 21 CFR 312.32(a)? 21 CFR 312.32(a). Outline: SOCRA CCRP exam outline, 2d Identify, document and report research study anomalies.
  • Which protocol change may be put into effect at once under 21 CFR 312.30(b)(2)(ii), before FDA is told and the IRB approves? 21 CFR 312.30(b)(2)(ii). Outline: SOCRA CCRP exam outline, 2a Execute research study.
  • Which statement must the immediate package of an investigational new drug bear, by 21 CFR 312.6(a)? 21 CFR 312.6(a). Outline: SOCRA CCRP exam outline, 2c Manage research study product.
  • Who is given a copy of the written consent form under 21 CFR 50.27(a)? 21 CFR 50.27(a). Outline: SOCRA CCRP exam outline, 2e Manage subjects.

Research study closure 8

  • A device investigation ends. How long does the investigator have to send a final report to the sponsor and the reviewing IRB (21 CFR 812.150(a)(6))? 21 CFR 812.150(a)(6). Outline: SOCRA CCRP exam outline, 3b Develop and submit research study closure reports.
  • A marketing application is approved for the drug and indication studied. How long after that date must the investigator keep the study records (21 CFR 312.62(c))? 21 CFR 312.62(c). Outline: SOCRA CCRP exam outline, 3c Archive and retrieve research study records.
  • A significant risk device investigation is completed. How soon must the sponsor notify FDA, by 21 CFR 812.150(b)(7)? 21 CFR 812.150(b)(7). Outline: SOCRA CCRP exam outline, 3b Develop and submit research study closure reports.
  • An investigator's participation in an IND study ends with unused drug on the shelf. What does 21 CFR 312.59 require of the sponsor? 21 CFR 312.59. Outline: SOCRA CCRP exam outline, 3a Perform or participate in a research study closeout visit.
  • By 42 CFR 11.44(a), when are results for an applicable clinical trial generally due at ClinicalTrials.gov? 42 CFR 11.44(a). Outline: SOCRA CCRP exam outline, 3b Develop and submit research study closure reports.
  • For how long after research is completed must an IRB keep its records, under 21 CFR 56.115(b)? 21 CFR 56.115(b). Outline: SOCRA CCRP exam outline, 3c Archive and retrieve research study records.
  • When a trial is completed, what should the investigator/institution give the IRB/IEC, by ICH E6(R3) section 2.13? ICH E6(R3), Annex 1, section 2.13. Outline: SOCRA CCRP exam outline, 3b Develop and submit research study closure reports.
  • When must an investigator give the sponsor a final report under 21 CFR 312.64(c)? 21 CFR 312.64(c). Outline: SOCRA CCRP exam outline, 3b Develop and submit research study closure reports.

How this list was compiled: Our own questions, written to the CCRP exam outline that SOCRA (the Society of Clinical Research Associates) publishes (https://socra.org/certification/ccrp-certification-exam/exam-outline/, and the detailed outline linked from it, https://socra.org/wp-content/uploads/2026/06/2501.1-Major-Content-Outline-241007.pdf, both read 2026-10-09). Its three content areas and their shares: Research Study Start-Up 40%, Research Study Implementation 50%, Research Study Closure 10%. The bank holds 32, 40 and 8 questions in that order. Every fact was read on 2026-10-09 in the public text the question names: the Code of Federal Regulations at ecfr.gov (21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR Part 46, 42 CFR Part 11), the ICH guidelines E6(R3) and E2A at database.ich.org, the Declaration of Helsinki at wma.net, the Nuremberg Code at ori.hhs.gov and the Belmont Report in the Wikisource copy. Licence: Questions, choices and explanations are original work of this site.

How it works

This SOCRA practice test has 80 questions of our own for the CCRP exam. It is unofficial: this site is not affiliated with, endorsed by or sponsored by SOCRA (the Society of Clinical Research Associates).

Read the full guide

Three content areas

The 80 questions follow the weights of SOCRA's exam outline: 32 on research study start-up, 40 on implementation and 8 on closure.

Written from the rules the exam tests

SOCRA's preparation page says the exam assesses the Code of Federal Regulations and the ICH E6 and E2A guidelines, not state or institutional policy. Each question cites its section: 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR Part 46, 42 CFR Part 11, the ICH guidelines, or the Nuremberg Code, Belmont Report and Declaration of Helsinki.

E6(R3), not R2

The same page says exam content reflects ICH E6(R3) from January 1, 2026. The good clinical practice questions here cite R3's section numbers, which differ from R2's.

Questions and answers

Is this SOCRA test practice free?

Yes: all 80 questions, with no account. Each answer links to the section of the regulation or guideline it was written from.

How many questions are on the SOCRA CCRP exam?

130 multiple-choice questions, by SOCRA's exam outline. 100 are scored and 30 are unscored beta test questions that are not identified. Each question has one correct answer, and a wrong answer carries no penalty.

What is the passing score for the SOCRA CCRP exam?

Candidates need 71 of the 100 scored questions right, by SOCRA's exam outline. Exam mode here draws 50 questions and marks them at the same 71 in 100.

Is this the official SOCRA practice test?

No. SOCRA sends approved applicants its own reference manual. This bank is separate and unofficial: every question is our own, written from the public regulation or guideline it names.

How much does the SOCRA CCRP exam cost?

US$510 for current SOCRA members and US$565 for non-members, by SOCRA's application page read October 9, 2026. Once a qualified applicant applies to take an examination, the fee is not refunded.

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