Verified CCRP Exam Dumps to Demonstrate Your Expertise: Pass Your Certified Clinical Research Professional (CCRP) Certification Exam Smoothly

1. 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?

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

3. 1.Which of the following is an example of an additional protection required when conducting research on children?

4. 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?

5. 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?

6. 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?

7. Which of the following is an adequate definition of quality assurance for the conduct of a clinical trial?

8. On 15 May 2019, a sponsor announced that its investigational compound GHB33IA will not be investigated any further and will not be pursued for a marketing approval.

According to the CFR, what is the earliest date when the site may begin to destroy the study records?

9. An investigator is working with a new sponsor to submit a cardiovascular trial to the IRB/IEC.

In accordance with the ICH GCP Guidelines, which parties should sign the protocol to confirm agreement that the trial will be conducted as agreed?

10. Which of the following entities, if any, must provide an approval before an investigator may enroll subjects in a quality-of-life research questionnaire study?

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

12. 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?

13. In accordance with the CFR, a sponsor must submit a protocol amendment to the FDA for which of the following?

14. A sponsor's monitor is conducting a site selection visit for an interventional drug trial.

In accordance with ICH GCP, which pharmacy drug storage facility information should be collected in order to determine whether the site could be selected for the trial?

15. An investigator received an updated investigator's brochure from the sponsor; the update did not include changes related to subject safety.

Which of the following parties, if any, is the investigator required to notify?

16. In accordance with the ICH GCP Guideline, which of the following can an Independent Data Monitoring Committee provide?

17. During an internal compliance review, the site study team identified that a protocol-required blood sample collection was not obtained for a majority of the subjects enrolled. In accordance with the ICH GCP Guideline, the clinical investigator should:

18. Which of the following would be considered an addendum to an investigator's brochure for an unapproved Investigational Product?

19. According to the CFR and the ICH GCP Guideline, which of the following must be submitted to the IRB after completion of the trial at the site?

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

21. 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?

22. 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?

23. 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?

24. In determining the classification of risk for a study involving a medical device, it is necessary to consider the:

25. The FDA may propose to terminate an IND during a Phase I study if the FDA finds that which of the following conditions exists?

26. In accordance with the CFR, clinical trial sponsors are required to retain records and reports after a marketing application is approved for at least:

27. 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?

28. 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?

29. 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?

30. 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:

31. For a study with a significant risk investigational medical device that could optimize the effects of radiation therapy on cancer tumors, the investigational plan states mild burns are an anticipated effect. One subject developed severe burns with blistering.

In accordance with the CFR, this effect must be reported to the sponsor and the IRB/IEC as soon as possible and at most how long after the investigator first learns of the effect?

32. Which document was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and summarizes the basic ethical principles and guidelines for the conduct of research involving human subjects?

33. 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?

34. A subject enrolled in a drug clinical trial has withdrawn from the study.

In accordance with ICH GCP, which of the following documents should be consulted to determine whether the participant should be replaced?

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?

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

37. In accordance with the ICH GCP Guideline, when a sponsor transfers trial-related duties and functions to a contract research organization (CRO), who is ultimately responsible for the quality and integrity of the trial data?

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

39. A pharmaceutical company is developing a biologic study. In accordance with ICH, which of the following items should be included in an investigator's brochure (IB)?

40. 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?

41. 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?

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

43. 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?

44. Which of the following is considered a source document?

45. In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?