SOCRA CCRP Exam ACTUAL EXAM QUESTIONS &
Verified ANSWERS WITH RATIONALES 2025 |GRADED
A+
When there is no additional relevant information to provide to the subject? - ANSWhen
is the informed consent process over?
Varied backgrounds, diversity and expertise
Upon earlier notification, investigations may begin - ANSHow long does it take for an
IND to go into effect? (21 CFR Part 312)
Uncontrolled (Long term expansion studies) - ANS5 Common Study Designs
Unapproved drug to be shipped lawfully for the purpose of conducting investigations of
the drug - ANSAn IND permits what? (21 CFR Part 312)
Unanticipated adverse device effect (UADE) - ANSWhat is the SAE counterpart in
device trials?
Triggered by NDA - ANSHow are study oriented FDA Inspections classified?
Triggered by data issue, complaint from study subject/staff, publication of results from
an ongoing study - ANSHow are investigator oriented FDA inspections classified?
To safeguard rights, safety and well being of all trial subjects
To pay special attention to trials that may include vulnerable subjects - ANSWhat are
the goals of an IRB? (21 CFR Part 56)
The subject only - ANS21 CFR Part 50 only requires who to sign the ICF?
The sponsor, the IRB evaluates the determination - ANSWho makes the initial
determination of SR or NSR?
the shipment of a device for the purpose of conducting investigations of the device
without complying without FDA requirements that would apply to devices in commercial
distribution - ANSWhat does an Investigational Device Exemption (IDE) permit?
The probability and magnitude of harm or discomfort anticipated in the research are not
greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological exams and tests - ANSIRB definition of
Minimal Risk
The Informed Consent Process - ANSWhen does the subject have the right to ask
questions about the study?
The Informed Consent Form - ANSWhat cannot include language that releases or
appears to release investigator, institution, sponsor or their agents from liability for
negligence?
The Informed Consent Form - ANSWhat cannot contain language that waives or
appears to waive the rights of the subject?
The FDA - ANSWho determines if Phase II/III studies are likely to yield data capable of
meeting regulatory standards for marketing approval?
temperature - ANSCore Battery for Central Nervous System
Table of Contents
surgical drapes - ANSExamples of Class II devices
Subjects may not be given the investigational drug - ANSWhat does a FDA "Clinical
Hold" mean for a proposed study?
