Acrp Practice Exam Questions Questions And Answers Graded A+

Which of the following required elements should be included in a clinical trial protocol? a. The subject's responsibilities b. The alternative treatments that may be available to the subject c. The subject inclusion and exclusion criteria d. The compensation available to the subject for trial-related injury {Ans: The subject inclusion and exclusion criteria}During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? a. Clinic's appointment schedule b. Electronic medical record c. Drug accountability records d. Recruitment log {Ans: Electronic medical record}A PI wants to start a clinical trial on acute stroke patients. Most of the patients will not be conscious when they arrive at the hospital with their family. Which of the following is true regarding the unconscious patients? {Ans: They will need a LAR to consent on their behalf.}An investigator is notified by the sponsor that a study will terminate. The PI would like to continue to follow the subjects for another year. What should the PI do? a. Continue following the subjects in the study b. Request permission from the IRB/IEC to continue the study c. Consent subjects to a new IRB/IEC approved