Pass CCRP Exam to Get SOCRA Certification

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September 28, 2025

The CCRP exam is hot, and passing it requires a deep understanding of SOCRA solutions. Practicing with SOCRA CCRP dumps questions can help you reinforce your knowledge and increase your chances of passing the exam. CCRP dumps are available to help you prepare for the CCRP exam. Using CCRP exam dumps questions is one effective way to supplement your study plan and increase your chances of success on exam day. Test free Clinical Research Professional CCRP exam dumps below.

Page 1 of 4

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

CMS approval letter

Orphan product evidence

IRB attestation of institutional cost burden

Evidence of potential clinical benefit and significant advantage

2. Which of the following statements about the initial IND application submission by a sponsor to the U.S. Food and Drug Administration is correct?

It is an application to export the investigational drug

It includes the rationale for human testing and a description of the general investigational plan

It is an application for the sponsor to sell the drug for profit

It includes a disclosure of the financial interests and arrangements of clinical investigators

3. 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?

The sponsor

The monitor

The investigator

The study coordinator

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

IRB/IEC

Sponsor

FDA

Pharmacist

5. In accordance with the Belmont Report, obtaining voluntary informed consent from subjects prior to enrolling them in a clinical trial is an example of which of the following ethical principles?

Do no harm

Respect for persons

Beneficence

Justice

6. In accordance with the ICH GCP Guideline, who is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the case report forms and in all required reports?

The clinical investigator

The quality control specialist

The IRB/IEC coordinator

The contract research organization monitor

7. A study subject in a double-blinded, placebo-controlled Phase III study experienced a serious adverse event that could be related to the study drug. The clinical investigator is out of town, and the sub-investigator needs to break the blind.

Where can the sub-investigator find a description of the unblinding procedure?

The informed consent form

The Investigator's Brochure

The study protocol

The case report form

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

Written information to be provided to the subjects

Requirements for storage of the investigational product

Sponsor's SOPs

IRB/IEC requirements for reporting to the regulatory authority

9. A study coordinator is preparing an IRB submission for a Phase II oncology study.

Which document must be included?

Case report forms

Recruitment materials

Record storage plan

List of potential subjects

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

The clinical investigator

A data safety monitoring board

The reviewing IRB/IEC

The medical monitor

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11. A Phase I clinical trial is initiating. Who is responsible for ensuring that site staff are adequately informed about trial duties?

Sponsor

Program manager

IRB/IEC

Clinical investigator

12. 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?

The investigator

The IRB/IEC chair

The sponsor

The CRO

13. In accordance with the CFR and the ICH GCP Guideline, which of the following is directly responsible for submitting protocols and amendments to the IRB/IEC for review?

The Food and Drug Administration

The investigator

The sponsor

The contract research organization

14. After the completion of a Phase II IND study closeout monitoring visit, which of the following parties is responsible for maintaining the closeout monitoring report?

The investigator

The sponsor

The study coordinator

The IRB/IEC

15. For an investigational new drug study that has potential side effects of myalgia, arthralgia, and lethargy, which of the following could serve as an acceptable consent statement?

You might experience adverse events of myalgia, arthralgia, and lethargy

You might have some muscle aches, joint pain, and tiredness

You might develop symptoms of myalgia, arthralgia, and tiredness

You might have some mild side effects while taking the investigational drug

16. In accordance with 45 CFR 46, in addition to the Office for Human Research Protections (OHRP), a suspension of IRB/IEC approval must be reported to which of the following?

The local hospital's bioethics committee

The appropriate institutional officials

The Scientific Review Committee

The local hospital's medical director

17. A subject currently on a clinical trial was hospitalized for 2 days due to a SAE. The subject reported the hospitalization to the investigator at the next study visit.

According to the ICH GCP Guideline, when should the investigator report the SAE to the sponsor?

Immediately

Within 7 working days

Within 10 working days

Within 15 working days

18. In accordance with the CFR, the IRB/IEC membership must have:

At least seven individuals

A majority of individuals whose primary area of expertise is nonscientific

At least one cleric

At least one individual who is not affiliated with the institution

19. A sponsor received a report from an investigator regarding the investigator's use of an investigational device without having obtained informed consent.

The sponsor must submit a copy of the report to the FDA within:

1 day

5 working days

10 working days

30 working days

20. When can the IRB/IEC require that additional information be given to subjects as part of informed consent?

At any time, at the discretion of the IRB/IEC

At any time, but only if the sponsor agrees that the information is essential

At any time, but only if the investigator agrees that the information is essential

At any time, but only if the sponsor and investigator agree that the information is essential

Page 3 of 4

21. 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?

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

Transferable to family

Identical to handwritten signature

Reassignable after validation

Cannot be reused or reassigned

23. In order to meet recruitment goals, a sponsor is adding a new site to a multi-center study.

Which of the following documents should the sponsor obtain from a new site prior to starting research at the site?

The site’s SOPs

The delegation of duties log

The site’s accreditation certificate

The IRB/IEC trial approval documentation

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

Occupations and affiliations of IRB members

Sponsor/investigator contracts

Subject enrollment logs

Investigational product labels

25. A coordinator for an ongoing industry-sponsored, multi-site Phase II clinical trial is taking an unexpected, long-term medical absence. The trial site retains coordinator services from an external source to support clinical trial activities.

According to the ICH GCP Guideline, which of the following is responsible for implementing procedures to ensure the integrity of the clinical trial-related duties?

The sponsor

The investigator/institution

The IRB/IEC

The external source

26. In accordance with 21 CFR Part 11, a closed electronic records system must do all EXCEPT:

Maintain accurate records throughout retention

Generate audit trails

Customize access rights

Print a complete paper copy

27. An investigator discovered a new serious unanticipated adverse device effect.

Who must they notify?

FDA

Sponsor

Research pharmacist

OHRP

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

China

Switzerland

Brazil

India

29. 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?

One year

Two years

Three years

Five years

30. A clinical investigator terminated a Phase IV drug study.

In accordance with the ICH GCP Guidelines, which of the following documents should the clinical investigator maintain?

The master randomization list

The completed subject identification code list

The final trial closeout monitoring report

The audit certificate

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31. According to ICH GCP, sponsor-specific essential documents must be retained until:

2 years after last approval and no pending applications

3 years after last approval

5 years after last approval

25 years after last approval

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

To establish diverse subject enrollment

To validate insurance reimbursement

To provide a record of subjects’ investigational medical treatment

To validate reports submitted to the IRB/IEC

33. Upon completion of a study, the investigator should do which of the following?

As soon as possible, provide the IRB/IEC with a final report that summarizes the trial's outcome

Ensure that all payments from sponsor have been received

Provide the IRB/IEC a final report, but only if the study has a positive outcome

Compile site data, publish the study results, and submit the publication to the IRB/IEC as the final report

34. A study coordinator is developing an informed consent form for the first time.

As per the CFR and ICH GCP Guideline, which of the following elements must be included?

An explanation of the person to contact at the sponsor for further information regarding research subjects’ rights

A note that the qualified investigator could be financially compensated by the sponsor to conduct the clinical trial

A statement confirming that the subject has received a copy of the signed consent document

A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

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

What is required?

Approval from monitor

Consent from subject

IRB chair approval

Nothing further

36. A company’s CEO wants to commercially promote a device under an IDE study. This plan:

Requires a large advertising budget

Would violate FDA regulations

Requires IRB/IEC approval

Requires IDE approval

37. Protocol increases drug dose by 20%. Baseline: 370 mg/m². New dose = ?

400 mg/m²

420 mg/m²

444 mg/m²

492 mg/m²

38. 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:

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

Sponsor and IRB/IEC immediately, then update later

Sponsor and IRB/IEC within five days

Sponsor and IRB/IEC within seven days

39. A clinical investigator received an honorarium from the sponsor of a covered study. At what payment value must this be reported?

Any amount

$5,000

$10,000

>$25,000

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

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

It is signed and dated by the IRB/IEC chair

It does not identify some of the applicable mandated basic elements

It identifies all of the applicable mandated basic elements

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