Exam for engine

NO.12 An investigator in a multicenter trial reports multiple occurrences of an SAE to the sponsor. Who is responsible for reporting the SAEs to the remaining sites’ IRB/IECs?

NO.13 A PI on a study is a regular member of the IRB/IEC. Which of the following statements is TRUE regarding their participation in the IRB/IEC discussion and deliberation?

NO.14 A sponsor wants to transfer duties to a CRO. Which of the following statements is the MOST correct?

NO.15 While consenting a potential subject, a coordinator discovered the subject could not read. Under what conditions can this potential subject be enrolled?

NO.16 The PI may assign responsibility for IP accountability to the pharmacist provided they are:

NO.17 Who is responsible to ensure training for key staff members unable to attend the site initiation visit?

NO.18 A serious unexpected ADR is one:

NO.19 AEs that occur between study visits of a clinical trial should be evaluated by the:

NO.20 Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?

NO.21 Who takes responsibility for initiating a clinical trial?

NO.22 A printed, optical, or electronic document designed to record all of the protocol-required information and is transmitted to the sponsor is called a:

NO.23 A potential subject is interested in a new clinical trial and would like to learn more about the risks and benefits of participation. Where can they find this information?

NO.24 In order to conduct open-label, parallel group clinical trials according to sound scientific principles, which of the following design elements should be included?

NO.25 Which document confirms the PI’s agreement to permit auditing at the study site?

NO.26 Preliminary evidence suggests a low-dose anti-cancer drug given for a short period of time may reduce the risk of developing cancer in patients who are at increased risk for developing cancer. The drug has potentially serious side effects. What is the MOST important question to consider before designing a clinical trial to test this hypothesis?