Use Free CCRP Exam Questions that Stimulates Actual EXAM [Q38-Q58]

NO.38 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?

NO.39 What is included in the Statement of Investigator (Form FDA 1572)?

NO.40 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:

NO.41 A subject has creatinine 1.6 mg/dL, slightly above eligibility (#1.5). Investigator believes this is normal for size. When can subject be enrolled?

NO.42 In a completed multi-site Phase I drug study using remote EDC, who ensures the system complies with accuracy and reliability requirements?

NO.43 Which of the following statements about the initial IND application submission by a sponsor to the U.S. Food and Drug Administration is correct?

NO.44 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?

NO.45 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?

NO.46 According to ICH GCP, who besides the sponsor should approve the financial aspects of a clinical trial?

NO.47 In accordance with the CFR, the sponsor (who is not a sponsor-investigator) is responsible for which of the following?

NO.48 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?

NO.49 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?

NO.50 In order to adequately monitor a clinical trial, the monitor must be familiar with each of the following, EXCEPT the:

NO.51 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?

NO.52 When can an IRB/IEC review a study using expedited review?

NO.53 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?

NO.54 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?

NO.55 The sponsor of a multi-institutional clinical trial provided a site with information regarding a newly identified unanticipated adverse event attributed to study drug administration. The site’s investigator has a subject actively receiving this study drug. Which of the following is the site investigator’s responsibility to the subject?

NO.56 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?

NO.57 A company’s CEO wants to commercially promote a device under an IDE study. This plan:

NO.58 Which of the following is one of the responsibilities of an investigator who is NOT a sponsor?