Answer Happy

A Data Monitoring Committee has the primary responsibility of: O A Determining if there are any conflicts of interests impacting patient safety O B. Ensuring all study participants are informed of all risks of the study OC. Making recommendations to Sponsors and IRBs regarding continuation and termination of studies D. A and B O E. All of the Above Question 9 2 pts A Data Monitoring Committee typically includes: O A. Individuals with clinical expertise related to the disease and treatments being studied O B. Principal Investigarer O C. Ethicist O D. Biostatistician O E A and B OF. A, B and C OG. A. C and D O H. All of the above
2 Question 6 The only federally mandated step for dealing with conflicts of interest in research studies involving human subjects is: O A. Investigator must not participate in a research study where he has an equity interest in company sponsoring study O B. IRB review of all financial conflicts OC. Disclosure of the conflict(s) O D. All of the above Question 7 2 pts Sponsors have Clinical Research Associates or a CRO monitor study sites for: O A. Informed Consent ompliance O B. Adverse Event Reporting O C. Data Accuracy of Case Report Entries O D. Adherence to Protocol O E. All of the Above
Using a placebo in a clinical trial is unacceptable O A. in life-threatening diseases O B. in case of potential irreversible damage when there is effective treatment available O c. when patients are adequately informed of risks involved in participating in a placebo controlled study O D. in studies of diseases where there is spontaneous remissions E. A and B F. A, B and D G. All of the above