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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 # 31

During an audit for a Phase II IND study, the auditor identified unreported serious protocol deviations. Which party must take prompt action to ensure compliance?

Options:

A.  

The investigator

B.  

The IRB/IEC chair

C.  

The sponsor

D.  

The CRO

Discussion 0
Question # 32

In accordance with the ICH GCP Guideline, at what intervals should the on-site study monitoring be performed?

Options:

A.  

At least weekly

B.  

Every 4–6 weeks until study close-out

C.  

In a timely manner before, during, and after the study

D.  

Once a year until study close-out

Discussion 0
Question # 33

The reviewing IRB/IEC determined that a minimal risk sponsor-investigator study is exempt from IRB/IEC review. How often, if ever, is the sponsor-investigator required to submit a continuing review to the IRB/IEC?

Options:

A.  

Every year

B.  

Every two years

C.  

Exactly one time, at study closure

D.  

There is no such requirement

Discussion 0
Question # 34

An IND application must contain all EXCEPT:

Options:

A.  

A cover sheet

B.  

Chemistry, manufacturing, and control information

C.  

Investigator’s brochure

D.  

Financial disclosure information

Discussion 0
Question # 35

Which of the following adverse events occurring during a study of an investigational new drug would require the sponsor to notify the FDA as soon as possible but in no case later than seven calendar days after the initial receipt of the information?

Options:

A.  

Aplastic anemia requiring hospitalization, mentioned in the investigator's brochure

B.  

An infection not related to the investigational drug requiring hospitalization for antibiotic therapy

C.  

Death as a result of arrhythmias (irregular heart rhythm), not mentioned in the investigator's brochure and thought to be related to the use of the drug

D.  

Death due to disease progression, mentioned in the investigator's brochure

Discussion 0
Question # 36

Sponsor must maintain drug disposition records for how long after marketing approval?

Options:

A.  

1 year

B.  

2 years

C.  

3 years

D.  

5 years

Discussion 0
Question # 37

A revised protocol added genomic testing to banked tissue samples. Before shipping samples, what must the site do?

Options:

A.  

Execute material transfer agreement

B.  

Ship under dangerous goods requirements

C.  

Obtain IRB/IEC approval for revised protocol and ICF

D.  

Notify enrolled subjects

Discussion 0
Question # 38

In accordance with the CFR, for at least how many years after the completion of a study must the clinical investigator provide the sponsor with relevant changes to financial information?

Options:

A.  

One year

B.  

Two years

C.  

Three years

D.  

Five years

Discussion 0
Question # 39

A sponsor-investigator implemented a protocol deviation in a device trial to eliminate an immediate hazard. Before applying this change to all subjects, what must occur?

Options:

A.  

Obtain IRB/IEC approval

B.  

Inform all subjects

C.  

Train sub-investigators

D.  

Document change in study file

Discussion 0
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