CTPRP EXAM 99 2026 MEDICAL ETHICS AND
REGULATORY COMPLIANCE DRILL PACK
ANSWER SHEET
◉ Who compiled the SOCRA Certification Program Reference
Manual?
Answer: An international task force of experts in the field of clinical
research under the direction of the SOCRA Certification Committee.
◉ What is FDA Form 482 used for?
Answer: Notice of Inspection.
◉ What does FDA Form 483 document?
Answer: Inspectional Observations.
◉ What is the purpose of FDA Form 1572?
Answer: Statement of Investigator.
◉ What does FDA Form 3454 certify?
Answer: Financial Interests and Arrangements of Clinical
Investigators.
,◉ What information does FDA Form 3455 disclose?
Answer: Financial Interests and Arrangements of Clinical
Investigators.
◉ What is FDA Form 3500 used for?
Answer: Voluntary Reporting of Adverse Events and Product
Problems.
◉ What is the purpose of FDA Form 3500A?
Answer: Mandatory Reporting by User Facilities, Distributors, and
Manufacturers.
◉ What is the Belmont Report primarily concerned with?
Answer: Ethical principles and guidelines for research involving
human subjects.
◉ What does the Nuremberg Code emphasize?
Answer: The necessity of voluntary consent in research involving
human subjects.
◉ What is the Declaration of Helsinki?
Answer: A set of ethical principles for medical research involving
human subjects.
,◉ What does the ICH Harmonised Guideline for Good Clinical
Practice E6 (R2) address?
Answer: Standards for the design, conduct, recording, and reporting
of clinical trials.
◉ What is the focus of ICH Clinical Safety Data Management: E2A?
Answer: Definitions and Standards for Expedited Reporting.
◉ Who governs the CCRP certification program?
Answer: The SOCRA Certification Committee.
◉ What is the main goal of the SOCRA Certification Committee?
Answer: To protect the integrity of the certification process.
◉ What stakeholders benefit from the CCRP certification program?
Answer: Public, government, regulatory agencies, academic research
institutions, and industry.
◉ What is the first section of the Candidate Handbook?
Answer: Introduction to the Society of Clinical Research Associates'
Certification Program.
, ◉ What is the purpose of the CCRP Certification Examination?
Answer: To assess the knowledge and skills of candidates seeking
certification.
◉ What does the Candidate Handbook outline regarding exam
preparation?
Answer: Guidelines for preparing for the exam.
◉ What is the significance of maintaining certification in the CCRP
program?
Answer: To ensure ongoing competence and adherence to
professional standards.
◉ What is the CCRP Certification Examination?
Answer: A certification exam for Clinical Research Professionals
offered in various locations throughout the U.S., Canada, and some
international locations.
◉ When was the CCRA examination first implemented?
Answer: August of 1995.
◉ What did the certification designation change from in January
2000?
REGULATORY COMPLIANCE DRILL PACK
ANSWER SHEET
◉ Who compiled the SOCRA Certification Program Reference
Manual?
Answer: An international task force of experts in the field of clinical
research under the direction of the SOCRA Certification Committee.
◉ What is FDA Form 482 used for?
Answer: Notice of Inspection.
◉ What does FDA Form 483 document?
Answer: Inspectional Observations.
◉ What is the purpose of FDA Form 1572?
Answer: Statement of Investigator.
◉ What does FDA Form 3454 certify?
Answer: Financial Interests and Arrangements of Clinical
Investigators.
,◉ What information does FDA Form 3455 disclose?
Answer: Financial Interests and Arrangements of Clinical
Investigators.
◉ What is FDA Form 3500 used for?
Answer: Voluntary Reporting of Adverse Events and Product
Problems.
◉ What is the purpose of FDA Form 3500A?
Answer: Mandatory Reporting by User Facilities, Distributors, and
Manufacturers.
◉ What is the Belmont Report primarily concerned with?
Answer: Ethical principles and guidelines for research involving
human subjects.
◉ What does the Nuremberg Code emphasize?
Answer: The necessity of voluntary consent in research involving
human subjects.
◉ What is the Declaration of Helsinki?
Answer: A set of ethical principles for medical research involving
human subjects.
,◉ What does the ICH Harmonised Guideline for Good Clinical
Practice E6 (R2) address?
Answer: Standards for the design, conduct, recording, and reporting
of clinical trials.
◉ What is the focus of ICH Clinical Safety Data Management: E2A?
Answer: Definitions and Standards for Expedited Reporting.
◉ Who governs the CCRP certification program?
Answer: The SOCRA Certification Committee.
◉ What is the main goal of the SOCRA Certification Committee?
Answer: To protect the integrity of the certification process.
◉ What stakeholders benefit from the CCRP certification program?
Answer: Public, government, regulatory agencies, academic research
institutions, and industry.
◉ What is the first section of the Candidate Handbook?
Answer: Introduction to the Society of Clinical Research Associates'
Certification Program.
, ◉ What is the purpose of the CCRP Certification Examination?
Answer: To assess the knowledge and skills of candidates seeking
certification.
◉ What does the Candidate Handbook outline regarding exam
preparation?
Answer: Guidelines for preparing for the exam.
◉ What is the significance of maintaining certification in the CCRP
program?
Answer: To ensure ongoing competence and adherence to
professional standards.
◉ What is the CCRP Certification Examination?
Answer: A certification exam for Clinical Research Professionals
offered in various locations throughout the U.S., Canada, and some
international locations.
◉ When was the CCRA examination first implemented?
Answer: August of 1995.
◉ What did the certification designation change from in January
2000?
