* 1. What is your email address (to receive results of the evaluation)?

* 2. Have you ever worked as a Monitor for clinical trials?

* 3. If yes, how many years did you monitor trials?

* 4. Have you ever worked as a Data Manager?

* 5.  Which of the following contributes most to clinical data quality?

* 6.  A risk-based approach to study monitoring is:

* 7. Which of the following is/are NOT a component of risk-based monitoring?

* 8. If EDC, handhelds, or other technology are used in a trial, which of the following is necessary for you to understand relative to the risk-based monitoring approach:

* 9. Company A is sponsoring a very complex study protocol (multiple subject cohorts, crossover design, short treatment phases, several steps to preparing treatments, multiple assessments on strict timeline). Consequently, they have identified site selection as a critical process to the success of the study. Which of the following should be among the highest priority considerations in qualifying a site for this trial?

* 10. A Monitor is reviewing a subject’s clinic chart and sees that the current medications include a medication for hypertension, and further that the dose was increased after the subject started participating in the study. While untreated hypertension is an exclusion, the medical history CRF does not identify the presence of hypertension or this medication. Please select the best answer.

Table 1.  Please use the following table for Questions 11-16:

Table 1.  Please use the following table for Questions 11-16:

* 11. According to Table 1, which site currently has the highest rate of screen failures?

* 12. According to Table 1, which site has the poorest compliance in data collection? Note: no screen failure data were captured.

* 13. According to Table 1, which of the following changes to the table would help you target sites with data compliance issues?

* 14. According to Table 1, which site(s) are you most concerned about with respect to SAE rates?

* 15. The Study sponsor identified several critical risks to the success of the study. One was the risk of subjects not completing the study. One site appears to be an outlier compared with the others with respect to subjects completed per protocol. What does the table tell you about potential contributing factors.

* 16. Sites 6 and 8 each had three changes in Study Coordinators from the time of the initial IRB submission. Based on the performance data, which of these sites might you be more concerned about and why?

Table 2:  Please use the following table to choose the best possible answer to each description below for Questions 17-22:

Table 2:  Please use the following table to choose the best possible answer to each description below for Questions 17-22:

Figure 1.  Please use the following graph for Questions 23-25:

Figure 1.  Please use the following graph for Questions 23-25:

* 23. According to Figure 1, which site had the best response from Word of Mouth?

* 24. Site 5 wants to run another television ad. Would you recommend that approach based on the data in Figure 1?

* 25. According to Figure 1, What recruitment approach has been the most effective for site 7?

* 26. In a study of a new wound care ointment, subjects participate in 14 clinic visits for lesion rating and treatment. Lesion ratings (scale of 0-7). For inclusion, the initial rating (visit 1) must be 0 or 1. At later visits, a rating may decrease 1 point from 2 back to 1, but ratings rarely decrease 2 or more points between visits, and once a rating of 5 or greater is seen it is not expected to decrease. Lesion rating was identified by the study Sponsor’s clinical risk analysis as a critical/high risk data element. As the Monitor taking a risk-based approach, what would you plan to mitigate this risk?

Table 3.  Please use the following table for Questions 27-28:

Table 3.  Please use the following table for Questions 27-28:

* 27. In another study medication dosing was identified in the Monitoring plan as a critical/high risk data element. Therefore, Data Management generates a report of subject-reported dosing data for central review/monitoring (Table 3). Per protocol, subjects were instructed to use at least 5 doses per day and to apply at least 5 drops/dose, until symptoms resolved, or for a maximum of 5 days. Subjects record dosing using a handheld device to transmit diary information to data management.  In order to have maximum oversight on dosing compliance, you should:

* 28. Central review of this kind of dosing report information (Table 3) can help you assess:

* 29. With risk-based monitoring, you will spend much less  time onsite:

* 30. The Principal Investigator announces that “The study is approved” what do you do next:

* 31. As input to the study monitoring plan, you were asked to participate in a risk assessment to identify the critical data and processes affecting study success. Which of the following is/are part of this activity?

* 32. We would like your comments on how we can improve the self assessment tool or any other comments you may have.

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