Weekend Sale Limited Time 70% Discount Offer - Ends in 0d 00h 00m 00s - Coupon code: merry71

Free Certified Clinical Research Professional (CCRP) Practice Questions

Exams4sure Dumps

Exam style questions across every CCRP domain

Last Update 1 day ago
Total Questions : 130

Start with our free CCRP practice questions, carefully crafted to mirror the domains, phrasing, and difficulty of the real Clinical Research Professional exam. Each CCRP exam question comes with a detailed rationale that explains not just which answer is correct but why the others fall short. That's how concepts stick. Use the free set to benchmark yourself: identify your SOCRA weak domains, see where you're losing marks, and build a focused study plan in minutes.

CCRP PDF

CCRP PDF (Printable)
$46.5
$154.99

CCRP Testing Engine

CCRP PDF (Printable)
$51
$169.99

CCRP PDF + Testing Engine

CCRP PDF (Printable)
$63.9
$212.99
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

Free Exams Sample Questions