SOCRA REAL EXAM AND STUDY GUIDE LATEST
2025-2026, 200 QUESTIONS AND CORRECT
ANSWERS//ALREADY GRADED A+
Overview
The SoCRA Certification Exam Study Guide 2025–2026 offers a complete, exam-style
learning experience for clinical research coordinators, associates, and professionals pursuing
SoCRA certification. With 200 expertly crafted questions, the guide mirrors the content outline
and difficulty of the real exam, covering all key domains of clinical research operations and
compliance. Updated for 2025–2026, it ensures alignment with current regulatory guidelines and
best practices. Designed by experienced research educators, this resource provides a realistic and
structured approach to mastering the SoCRA exam while strengthening practical understanding
of ethical and regulatory responsibilities in clinical trials.
Key Features
✅ 200 Verified Questions with Correct Detailed Answers
✅ Aligned with 2025–2026 SoCRA Exam Blueprint
✅ Comprehensive Coverage of GCP, FDA, and ICH Guidelines
✅ Developed and Reviewed by Certified Research Professionals
✅ A+ Graded Content for Accuracy and Reliability
Your Complete SoCRA Exam Prep Resource
With 200 verified questions and detailed explanations, the SoCRA Certification Exam Study
Guide 2025–2026 provides the most accurate, current, and comprehensive preparation for
mastering clinical research principles and passing the certification exam with confidence.
Which FDA Form is used for Mandatory Reporting of Adverse Events and Product Problems?
A. Form 3455
B. Form 3500
C. Form 3500A
D. Form 1572 - ANSWER-C. Form 3500A
,Disclosure: Financial Interests and Arrangements of Clinical Investigators would also be known
as:
A. Form 3455
B. Form 3454
C. Form 3500
D. Form 1572 - ANSWER-A. Form 3455
Certification: Financial Interest and arrangements of Clinical Investigators would also be known
as:
A. Form 3455
B. Form 3454
C. Form 3500
D. Form 1572 - ANSWER-B. Form 3454
The investigator's financial interests with the pharmaceutical company (sponsor) or to the
outcome of the clinical investigation is reported directly to the FDA by:
A. The investigator
B. The IRB
C. The investigator's institution
D. The applicant - ANSWER-D. The applicant
The Form FDA 3455 is completed by
A. The applicant
B. The FDA
C. The investigator
D. The study coordinator - ANSWER-A. The applicant
The Form FDA 3500 is used for
,A. Financial Disclosures
B. Inspections
C. Voluntary reporting
D. Mandatory reporting - ANSWER-C. Voluntary reporting
FDA Form 3500A is used for
A. Financial Disclosures
B. Inspections
C. Voluntary reporting
D. Mandatory reporting - ANSWER-D. Mandatory reporting
Clinical Investigators financial disclosures are submitted on
A. Form FDA 1572
B. Form FDA 3454
C. Form FDA 3500A
D. Form FDA 3455 - ANSWER-D. Form FDA 3455
The FDA requires retention of investigational drug study records for?
A. Indefinitely
B. At least three years after the study has ended at the site
C. At least two years after the investigational drug's approval by the FDA
D. At least one year after the last subject completes all study interventions - ANSWER-C. At
least two years after the investigational drug's approval by the FDA
According to ICH guidelines, how long must an IRB retain its records for each research project?
A. 2 years after completion of the trial
, B. 3 years after completion of the trial
C. 3 years after the marketing application is approved
D. 5 years after the completion of the trial - ANSWER-B. 3 years after completion of the trial
According to FDA regulation, how long must an IRB retain records?
A. 2 years after the study closes at the site
B. 3 years after completion of the research
C. 3 years after the marketing application is approved
D. According to the protocol - ANSWER-B. 3 years after completion of the research
According to ICH GCP how long should investigators maintain study records?
A. 3 years after completion of the study
B. 2 years after the study is closed at the site
C. 2 years following the last approval of a marketing application
D. 3 years after the investigation is discontinued - ANSWER-C. 2 years following the last
approval of a marketing application
Which of the following best describes when the majority of case report form (CRF) data are
verified against source record information?
A. Site initiation visit
B. Termination site visit
C. Periodic site visits
D. Prestudy site visit - ANSWER-C. Periodic site visits
Which of the following should take place during periodic monitoring visits?
A. Analysis of data
2025-2026, 200 QUESTIONS AND CORRECT
ANSWERS//ALREADY GRADED A+
Overview
The SoCRA Certification Exam Study Guide 2025–2026 offers a complete, exam-style
learning experience for clinical research coordinators, associates, and professionals pursuing
SoCRA certification. With 200 expertly crafted questions, the guide mirrors the content outline
and difficulty of the real exam, covering all key domains of clinical research operations and
compliance. Updated for 2025–2026, it ensures alignment with current regulatory guidelines and
best practices. Designed by experienced research educators, this resource provides a realistic and
structured approach to mastering the SoCRA exam while strengthening practical understanding
of ethical and regulatory responsibilities in clinical trials.
Key Features
✅ 200 Verified Questions with Correct Detailed Answers
✅ Aligned with 2025–2026 SoCRA Exam Blueprint
✅ Comprehensive Coverage of GCP, FDA, and ICH Guidelines
✅ Developed and Reviewed by Certified Research Professionals
✅ A+ Graded Content for Accuracy and Reliability
Your Complete SoCRA Exam Prep Resource
With 200 verified questions and detailed explanations, the SoCRA Certification Exam Study
Guide 2025–2026 provides the most accurate, current, and comprehensive preparation for
mastering clinical research principles and passing the certification exam with confidence.
Which FDA Form is used for Mandatory Reporting of Adverse Events and Product Problems?
A. Form 3455
B. Form 3500
C. Form 3500A
D. Form 1572 - ANSWER-C. Form 3500A
,Disclosure: Financial Interests and Arrangements of Clinical Investigators would also be known
as:
A. Form 3455
B. Form 3454
C. Form 3500
D. Form 1572 - ANSWER-A. Form 3455
Certification: Financial Interest and arrangements of Clinical Investigators would also be known
as:
A. Form 3455
B. Form 3454
C. Form 3500
D. Form 1572 - ANSWER-B. Form 3454
The investigator's financial interests with the pharmaceutical company (sponsor) or to the
outcome of the clinical investigation is reported directly to the FDA by:
A. The investigator
B. The IRB
C. The investigator's institution
D. The applicant - ANSWER-D. The applicant
The Form FDA 3455 is completed by
A. The applicant
B. The FDA
C. The investigator
D. The study coordinator - ANSWER-A. The applicant
The Form FDA 3500 is used for
,A. Financial Disclosures
B. Inspections
C. Voluntary reporting
D. Mandatory reporting - ANSWER-C. Voluntary reporting
FDA Form 3500A is used for
A. Financial Disclosures
B. Inspections
C. Voluntary reporting
D. Mandatory reporting - ANSWER-D. Mandatory reporting
Clinical Investigators financial disclosures are submitted on
A. Form FDA 1572
B. Form FDA 3454
C. Form FDA 3500A
D. Form FDA 3455 - ANSWER-D. Form FDA 3455
The FDA requires retention of investigational drug study records for?
A. Indefinitely
B. At least three years after the study has ended at the site
C. At least two years after the investigational drug's approval by the FDA
D. At least one year after the last subject completes all study interventions - ANSWER-C. At
least two years after the investigational drug's approval by the FDA
According to ICH guidelines, how long must an IRB retain its records for each research project?
A. 2 years after completion of the trial
, B. 3 years after completion of the trial
C. 3 years after the marketing application is approved
D. 5 years after the completion of the trial - ANSWER-B. 3 years after completion of the trial
According to FDA regulation, how long must an IRB retain records?
A. 2 years after the study closes at the site
B. 3 years after completion of the research
C. 3 years after the marketing application is approved
D. According to the protocol - ANSWER-B. 3 years after completion of the research
According to ICH GCP how long should investigators maintain study records?
A. 3 years after completion of the study
B. 2 years after the study is closed at the site
C. 2 years following the last approval of a marketing application
D. 3 years after the investigation is discontinued - ANSWER-C. 2 years following the last
approval of a marketing application
Which of the following best describes when the majority of case report form (CRF) data are
verified against source record information?
A. Site initiation visit
B. Termination site visit
C. Periodic site visits
D. Prestudy site visit - ANSWER-C. Periodic site visits
Which of the following should take place during periodic monitoring visits?
A. Analysis of data
