ACTUAL QUESTIONS AND CORRECT
Answers
What is the purpose of the SOCRA To assist clinical research professionals in
Certification Program Reference preparation for the Society of Clinical Research
Manual? Associates (SOCRA) certification examination.
Who compiled the SOCRA An international task force of experts in the field
Certification Program Reference of clinical research under the direction of the
Manual? SOCRA Certification Committee.
What is FDA Form 482 used for? Notice of Inspection.
, What does FDA Form 483 Inspectional Observations.
document?
What is the purpose of FDA Form Statement of Investigator.
1572?
What does FDA Form 3454 certify? Financial Interests and Arrangements of Clinical
Investigators.
What information does FDA Form Financial Interests and Arrangements of Clinical
3455 disclose? Investigators.
What is FDA Form 3500 used for? Voluntary Reporting of Adverse Events and
Product Problems.
What is the purpose of FDA Form Mandatory Reporting by User Facilities,
3500A? Distributors, and Manufacturers.
What is the Belmont Report Ethical principles and guidelines for research
primarily concerned with? involving human subjects.
What does the Nuremberg Code The necessity of voluntary consent in research
emphasize? involving human subjects.