Get the CCDM Exam Dumps (V8.02) to Pass Your SCDM Certified Clinical Data Manager (CCDM) Certification Exam on the First Try

1. The result set from the query below would be which of the following?

SELECT Pt_ID, MRN, SSN FROM patient

2. What is the main reason 21 CFR Part 11 requires that EDC systems maintain an audit trail?

3. Which competency is necessary for EDC system use in a study using the medical record as the source?

4. A study collects blood pressure.

Which is the best way to collect the data?

5. When reviewing local lab data from a paper study, a Data Manager notices there are lab values not entered.

What should the Data Manager request data-entry personnel do?

6. All of the following are preparation processes the data manager needs to take prior to database closure EXCEPT:

7. Which is the most important reason for why a data manager would review data before a monitor reviews it?

8. An organization is using an international data exchange standard and a new version is released.

Which of the following should be assessed first?

9. What action should a data manager take if an investigator retires in the middle of an EDC trial and the replacement does not agree to use EDC for the remainder of the trial?

10. Which list should be provided to support communication with sites regarding late data and queries?

11. The primary reason for system validation is to:

12. During testing of an ePRO system, a test fails.

Which information should be found in the validation documentation?

13. In an EDC study, an example of an edit check that would be inefficient to run at data entry is a check:

14. 1.According to the FDA Guidance for Industry, Providing Regulatory Submissions in Electronic Format (April 2006) and Good Clinical Data Management Practices (GCDMP, May 2007), which of the following is the most acceptable for a derived field?

15. Which of the following factors can be tested through a second test transfer?

16. Query rules were tested with test data for each logic condition within each rule.

Which of the following types of testing was conducted?

17. A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy of an antiviral to counteract a new epidemic. The stated primary efficacy endpoint is 3-month survival.

Which data element is needed for the primary efficacy endpoint?

18. Which is a minimum prerequisite that should be in place before choosing an EDC system?

19. Which method would best identify inaccuracies in safety data tables for an NDA?

20. A study numbers subjects sequentially within each site and does not reuse site numbers.

Which information is required when joining data across tables?

21. A Data Manager is importing data from an external facility.

Which is commonly checked first?

22. Which metric will identify edit checks that may not be working properly?

23. Which of the following is a best practice for creating eCRFs for a study?

24. Which is the best way to see site variability in eligibility screening?

25. What method is used for quality control of the query resolution process?

26. The Medical Dictionary for Regulatory Activities (MedDRA) structure is in which of the following hierarchical orders, from most specific to least specific?

27. Which Clinical Study Report section would be most useful for a Data Manager to review?

28. Which metric reveals the timeliness of the site-work dimension of site performance?

29. Which document describes what study subjects expect with respect to data disclosure during and after a study?

30. Which document contains the details of when, to whom, and in what manner the vendor data will be sent?

31. A study is collecting ePRO assessments as well as activity-monitoring data from a wearable device.

Which data should be collected from the ePRO and activity-monitoring devices to synchronize the device data with the visit data entered by the site?

32. What should be done if the site continues to provide inconsistent data after several re-queries?

33. What are the first logical specifications that need approval when building an efficient EDC database?

34. A study has an expected enrollment period of one year but has subject recruitment issues. Twelve new sites are added toward the end of the expected enrollment period to help boost enrollment.

What is the most likely impact on data flow?

35. What does 21 CFR Part 11 dictate in regards to a minimum expectation of EDC training prior to access?

36. Which of the following SOPs are required for management of an EDC system?

37. Which of the following roles commonly requires data entry and update privileges in an EDC application used in a clinical study?

38. A study is collecting pain levels three times a day.

Which is the best way to collect the data?

39. An international study collects lab values. Sites use different units in the source documents.

Which of the following data collection strategies will have fewer transcription errors?

40. Which of the following is the best reason for a statistician to review the case report form prior to using it in a study?

41. Which statement is true regarding User Acceptance Testing (UAT) in an EDC application?

42. In an EDC study, user training and access must be monitored and addressed when all the following situations occur EXCEPT:

43. A data manager takes the INTERSECTION data in two tables wanting only the 50 records common to both tables.

What operation did the data manager perform?

44. A Data Manager is drafting a report for clinical operations staff for support in responding to questions about milestone-based site payments.

Which is the most important information to display?

45. Which of the following laboratory findings is a valid adverse event reported term that facilitates auto coding?

46. Every database lock should follow documented approval of which stakeholders?

47. With the implementation of EDC, which company Standard Operating Procedure (SOP) would require updates for new procedures of handling data?

48. Which is the best reason why front-end checks are usually kept minimal, when compared to back-end checks, in a paper-based clinical study?

49. To ensure data quality and efficient integration of data, which of the following best describes the main topic that should be covered in initial discussions with a vendor providing the external data?

50. Electronic submission standards require that an individual subject's complete CRF should be provided as what type of file:

51. A sponsor may transfer responsibility for any or all of their obligations to a contract research organization.

Which of the following statements is true?

52. Which information is most useful in working with sites to catch up a backlog of unresolved queries at sites?

53. Which of the following statements would be BEST included in a data management plan describing the process for making self-evident corrections in a clinical database?

54. ACME Intervention Co. is testing a new carotid artery stent in patients with coronary artery disease, in hopes of proving superiority over the current standard of care. After a subject signs consent, the surgeon enrolls the patient and retrieves information on which stent to use, but the surgeon does not share this information with the subject. Yesterday, the surgeon was instructed to use the control stent. Today, the surgeon has completed two surgeries: the first one the surgeon was instructed to use the control stent; the second one the surgeon was instructed to use the test stent.

In what type of trial is the surgeon participating?

55. In development of CRF Completion Guidelines (CCGs), which is a minimum requirement?