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CCRP Practice Exam Questions with Answers Certified Clinical Research Professional (CCRP) Certification

Question # 6

According to the ICH/GCP Guideline, which of the following should a sponsor provide to the clinical investigator before entering into a clinical trial agreement?

A.

Staff training

B.

Adequate resources

C.

Proper equipment

D.

The protocol

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Question # 7

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

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

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Question # 8

What is included in the Statement of Investigator (Form FDA 1572)?

A.

A statement disclosing investigator financial interests

B.

A statement responding to FDA inspection observations

C.

A statement describing preclinical and human safety data

D.

A statement agreeing to comply with FDA regulations

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Question # 9

In accordance with the ICH GCP Guideline and the CFR, who is directly responsible for ensuring that an IRB/IEC will conduct the initial and continuing review of a study?

A.

The sponsor

B.

The monitor

C.

The investigator

D.

The study coordinator

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Question # 10

In accordance with the ICH GCP Guideline, which of the following should the investigator refer to when a subject returns unused medication at the completion of a study?

A.

The Investigator's Brochure

B.

The sponsor's written procedures

C.

The CRO/site agreements

D.

The investigational pharmacy's requirements

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Question # 11

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?

A.

1 day

B.

7 days

C.

10 days

D.

15 days

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Question # 12

Which countries have officially adopted ICH-GCP E6(R2) as a standard, in addition to U.S., EU, Japan, Canada, and Australia?

A.

China

B.

Switzerland

C.

Brazil

D.

India

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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:

A.

Phase I

B.

Phase II

C.

Phase III

D.

Phase IV

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Question # 14

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?

A.

Obtain IRB/IEC approval

B.

Inform all subjects

C.

Train sub-investigators

D.

Document change in study file

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Question # 15

In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:

A.

Written information to be provided to the subjects

B.

Requirements for storage of the investigational product

C.

Sponsor's SOPs

D.

IRB/IEC requirements for reporting to the regulatory authority

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Question # 16

A subject on a multi-drug regimen could not tolerate a non-investigational drug. Can the investigational regimen continue?

A.

Yes, per protocol

B.

Only after sponsor and IRB approval

C.

Only after medical monitor approval

D.

Only for a short time, then change to placebo

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Question # 17

After completion of a Phase III trial, which document should IRB/IEC retain?

A.

Occupations and affiliations of IRB members

B.

Sponsor/investigator contracts

C.

Subject enrollment logs

D.

Investigational product labels

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Question # 18

A clinical investigator wants to publish a subject’s unique results. The consent form did not mention publication. What is required?

A.

Approval from monitor

B.

Consent from subject

C.

IRB chair approval

D.

Nothing further

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Question # 19

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:

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

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Question # 20

While reviewing site records during a monitoring visit, a monitor can cite which of the following as a site violation of informed consent regulations?

A.

A subject’s signature is missing on the copy of the summary of the short form consent

B.

A copy of the consent document was not provided to a subject

C.

Only the signatures of the person obtaining consent and the witness appear on the copy of the summary of the short form consent

D.

The sponsor-generated informed consent template is missing required elements

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Question # 21

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

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

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Question # 22

In accordance with 21 CFR Part 11, in order for an electronic record to be equivalent to a paper record the electronic record must be:

A.

Printed, signed, and dated

B.

Managed within a validated computer system

C.

Entered into an electronic case report form

D.

Restricted to authorized clinical trial personnel

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Question # 23

After the sponsor’s auditor completes the final audit report for a Phase II trial with an investigational new drug, which of the following is responsible for providing the audit certificate to the clinical site?

A.

The IRB/IEC

B.

The regulatory authority

C.

The Data Safety Monitoring Board

D.

The sponsor

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Question # 24

A subject was instructed to do a glucose check 4 times a day for 10 days using an investigational glucose meter. The meter requires one new glucose test strip for each test. The subject received the meter along with 45 glucose test strips. How many unused test strips should the subject have after the 10 days?

A.

0

B.

5

C.

31

D.

35

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Question # 25

According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?

A.

OHRP

B.

Investigator/institution

C.

Regulatory authority

D.

DSMB

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Question # 26

An IND application must contain all EXCEPT:

A.

A cover sheet

B.

Chemistry, manufacturing, and control information

C.

Investigator’s brochure

D.

Financial disclosure information

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Question # 27

A research assistant on a study was recently promoted to a clinical research coordinator (CRC) role after one year on the study. In order to fulfill the significant new responsibilities, the CRC completed additional institutional training. According to ICH GCP Guidelines and 21 CFR, which of the following must be filed in the regulatory binder?

A.

The letter documenting the promotion to a CRC

B.

A brochure from the training course

C.

An updated performance review summary

D.

An updated curriculum vitae

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Question # 28

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?

A.

A scientific review board

B.

The FDA

C.

The Office for Human Research Protections (OHRP)

D.

An IRB/IEC

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Question # 29

In accordance with the CFR, which of the following statements regarding the informed consent document is correct?

A.

It is signed and dated by the subject’s legally authorized representative

B.

It is signed and dated by the IRB/IEC chair

C.

It does not identify some of the applicable mandated basic elements

D.

It identifies all of the applicable mandated basic elements

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Question # 30

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

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

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Question # 31

Which of the following statements about the FDA's authority to inspect IRB/IEC records is correct?

A.

The FDA may inspect them at reasonable times, in a reasonable manner, but may not take copies unless requested with an affidavit

B.

The FDA may inspect them at reasonable times, in a reasonable manner, and may take copies of IRB/IEC records

C.

The FDA does not have regulatory authority to inspect them

D.

The FDA may inspect them only if the IRB/IEC formally requests inspection

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Question # 32

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?

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

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Question # 33

Why would a Phase IV study be conducted?

A.

Different dosage

B.

Different schedule of administration

C.

Different off-label population

D.

Different marketing strategy

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Question # 34

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

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

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Question # 35

Which of the following identifies content that should be included in a clinical research protocol?

A.

IRB/IEC approval and meeting minutes

B.

Standard operating procedures for data collection

C.

Criteria for the selection of an investigator

D.

A summary of findings of nonclinical studies that potentially have clinical significance

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Question # 36

A physician with 20 years of experience is planning to be the site investigator for a multi-center, Phase I oncology clinical trial. In accordance with the ICH GCP Guideline, which of the following documents should the physician provide to the sponsor and the IRB/IEC?

A.

Proof of citizenship

B.

A letter of recommendation from a fellow physician

C.

A curriculum vitae

D.

A copy of medical license

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Question # 37

In an IND study, the specified dosage of an investigational product is 2 mg twice a day for 10 days. The product is available in 1 mg tablets. The subject was given 45 tablets and was instructed to take 2 mg of the product twice a day for 10 days. How many tablets should the subject have after the 10 days?

A.

0

B.

1

C.

5

D.

20

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Question # 38

A clinical investigator is developing the assent procedure for the enrollment of children into a new pediatric clinical trial. The ages of the children are described in the IRB/IEC submission. A description of which of the following must also be included in the submission?

A.

The psychological status of the children

B.

The economic status of the children

C.

The physiological status of the children

D.

The pediatrician (primary care provider notification process)

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Question # 39

During an IND study closeout, a monitor discovered remaining investigational product. Which procedures must be followed for disposition?

A.

Sponsor’s procedures

B.

IRB/IEC’s procedures

C.

Regulatory authority’s procedures

D.

Dispensing pharmacy’s procedures

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