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CCRP Practice Questions

Certified Clinical Research Professional (CCRP)

Last Update 1 day ago
Total Questions : 130

Dive into our fully updated and stable CCRP practice test platform, featuring all the latest Clinical Research Professional exam questions added this week. Our preparation tool is more than just a SOCRA study aid; it's a strategic advantage.

Our free Clinical Research Professional practice questions crafted to reflect the domains and difficulty of the actual exam. The detailed rationales explain the 'why' behind each answer, reinforcing key concepts about CCRP. Use this test to pinpoint which areas you need to focus your study on.

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Question # 11

An investigator discovered a new serious unanticipated adverse device effect. Who must they notify?

Options:

A.  

FDA

B.  

Sponsor

C.  

Research pharmacist

D.  

OHRP

Discussion 0
Question # 12

In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?

Options:

A.  

Institution

B.  

Sponsor

C.  

Regulatory authority

D.  

Investigator

Discussion 0
Question # 13

A nonrandomized study of 30 subjects entitled "A study to evaluate the effectiveness of and to determine the common short-term side effects associated with the drug 'PainStop' for the treatment of subjects with chronic arthritis" is an example of a:

Options:

A.  

Phase I

B.  

Phase II

C.  

Phase III

D.  

Phase IV

Discussion 0
Question # 14

For a Significant Risk device study, an investigator must report within 5 working days which event?

Options:

A.  

Unanticipated adverse effect

B.  

Completion of investigation

C.  

Withdrawal of FDA approval

D.  

Emergency deviation

Discussion 0
Question # 15

A physician wants to conduct research using an approved/marketed cardiac stent for use in the carotid artery, which is not an indication for which the device is approved. In this case, the physician must obtain which of the following?

Options:

A.  

The Office for Human Research Protections (OHRP) and manufacturer approvals

B.  

IRB/IEC approval and an FDA IND

C.  

IRB/IEC approval and an FDA IDE

D.  

IRB/IEC and manufacturer approval

Discussion 0
Question # 16

A clinical investigator is planning to conduct a quality of life medical device study in the United States. The study has been designed to comply with the approved indication for use of the device. In this situation, who must approve the investigator’s proposed patient recruitment materials?

Options:

A.  

A scientific review board

B.  

The FDA

C.  

The Office for Human Research Protections (OHRP)

D.  

An IRB/IEC

Discussion 0
Question # 17

The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?

Options:

A.  

The sponsor failed to submit an accurate annual report of the study to the FDA

B.  

The reviewing IRB/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study

C.  

An investigator failed to submit safety reports to the FDA

D.  

The FDA issued a clinical hold, and 30 days have elapsed

Discussion 0
Question # 18

Which document was created as a response to unethical WWII human experiments?

Options:

A.  

Declaration of Helsinki

B.  

Nuremberg Code

C.  

Belmont Report

D.  

Food, Drug, and Cosmetic Act

Discussion 0
Question # 19

According to the ICH GCP Guidelines, what is the purpose of source documents?

Options:

A.  

To establish diverse subject enrollment

B.  

To validate insurance reimbursement

C.  

To provide a record of subjects’ investigational medical treatment

D.  

To validate reports submitted to the IRB/IEC

Discussion 0
Question # 20

An investigator received $60,000 equity interest three years after study completion. What is the financial reporting requirement?

Options:

A.  

None

B.  

Report to FDA

C.  

Report to OHRP

D.  

Report to sponsor

Discussion 0
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