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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 # 21

An investigator received an updated informed consent form (ICF) from the sponsor for a study closed to enrollment. Subjects are only in long-term follow-up. The change related to frequent radiation imaging at screening, with no change to drug safety profile. Who must the investigator notify first?

Options:

A.  

Sub-investigators

B.  

Participants in long-term follow-up

C.  

The IRB/IEC

D.  

No notification is required

Discussion 0
Question # 22

An approved investigational device exemption (IDE) permits a device to be:

Options:

A.  

Shipped lawfully for the purpose of conducting a clinical study

B.  

Sold and marketed for profit

C.  

Used on a patient who is not enrolled on a clinical study

D.  

Marketed as a humanitarian device

Discussion 0
Question # 23

In a Phase III cardiovascular trial, who is responsible for ongoing clinical trial safety evaluation?

Options:

A.  

IRB/IEC

B.  

Sponsor

C.  

FDA

D.  

Pharmacist

Discussion 0
Question # 24

If a subject experiences a serious adverse event related to the study drug and only minimal information is available, the investigator must submit the information to the:

Options:

A.  

IRB/IEC immediately, then sponsor when full details are available

B.  

Sponsor and IRB/IEC immediately, then update later

C.  

Sponsor and IRB/IEC within five days

D.  

Sponsor and IRB/IEC within seven days

Discussion 0
Question # 25

Before approving a research protocol, an IRB/IEC must determine compliance with which of the following requirements?

Options:

A.  

A plan for the publication of study results is in place

B.  

The selection of subjects is equitable

C.  

The investigator has adequate access to patients eligible for the trial

D.  

The sponsor is qualified to provide oversight of the trial

Discussion 0
Question # 26

According to 21 CFR Part 11, each electronic signature must be unique and:

Options:

A.  

Transferable to family

B.  

Identical to handwritten signature

C.  

Reassignable after validation

D.  

Cannot be reused or reassigned

Discussion 0
Question # 27

An investigator’s responsibilities for conducting clinical trials include:

Options:

A.  

Maintaining IRB meeting minutes

B.  

Observing preclinical drug effects

C.  

Maintaining financial documentation for study staff

D.  

Administering or overseeing investigational drug administration

Discussion 0
Question # 28

A sponsor is permitted to charge for an investigational drug but must provide what documentation?

Options:

A.  

CMS approval letter

B.  

Orphan product evidence

C.  

IRB attestation of institutional cost burden

D.  

Evidence of potential clinical benefit and significant advantage

Discussion 0
Question # 29

In accordance with the CFR, which body must determine that a study meets the criteria for minimal risk?

Options:

A.  

The clinical investigator

B.  

A data safety monitoring board

C.  

The reviewing IRB/IEC

D.  

The medical monitor

Discussion 0
Question # 30

In accordance with the ICH E2A Guideline, the sponsor must report an adverse event that is life-threatening, unexpected, and associated with the investigational drug to the regulatory authority as soon as possible but no later than how many calendar days after first knowledge of the event?

Options:

A.  

1 day

B.  

7 days

C.  

10 days

D.  

15 days

Discussion 0
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