CDM interveiw questions – clinical data management Interveiw questions for freshers

Hellow friends in this article I have given below Interveiw questions which can be asked in Interveiw. So do refer this questions before going for interview.

CDM interveiw questions

clinical data management Interveiw questions for freshers

0.What is clinical data management?

1.Being A CD Manager CD Is Your Contribution Going To Be CD in this company?

2.Who Is The Father Of Clinical Trials?

3. In Health Care, Can You Tell Me The Synonyms Of Ct?

4.Define The Ct?

5.Define Unapproved Therapeutic Goods?

6.What Is Ind?

7.Describe The Importance Of Inclusion And Exclusion Criteria?

8.What Is Meant By Masking Or Blinding?

9.What Is Placebo?

10.What Is A Patient File? What Information Is Available on It?

11.What Are Pre-Clinical Studies?

12.Explain The Different Phases Of Clinical Trials?

13.Describe The Scientific Names For All 4 Phases Of Trials?

14.What Are Orphan Trials?

15.What Are Pk Parameters?

16.What Is ADME?

17.What Is Bioavailability?

18.What Is Bioequivalence?

19.What Is The Range Of Participants In Each Of The Four Phases Of Clinical Trials?

20.What Is Efficacy?

21.What Is Potency?

22.What Is Nce?

23.What Are The Contents Of An Ind Application?

24.List The Responses Of Fda On And Nda(new Drug Application)?

25.State The 13 Core Principles Of Ich-gcp Guidelines?

26.Who Are The Observers Of Ich?

27.Who Are The Participants Of Pharmacovigilance?

28.What Is The Need For Pharmacovigilance?

29.Describe The Attributes Of AE?

30.Schedule Y Requirements According To Sae?

31.Role Of Principal Investigator (pi)?

32.What Is Ctms? 33.What Is Cdms?

34.What Is Ib? 35.What Is a Protocol Document?

36.What Are The Means Of Recruiting Subjects For A Clinical Trial?

37.What Are The Means Of Recruiting Subjects For A Clinical Trial?

38.What Is Informed Consent?

39.Why Is Randomization Required In A Trial?

40.What Is Crf And What Is It’s Importance?

41.What Is Data?

42.What Is a Source Document?

43.What Are The Documents Required To Be Kept At The Study Site?

44.What are Common Data Elements (cde)?

45.What Is the Audit Trail?

46.What Is Double Data Entry? What Is It’s Importance?

47.What Are The Best Solutions For Clinical Data Management?

48.Define Digitization?

49.What Is Db Closure?

50.What Is The Best Analytical Tool?

51.What Is Discrepancy Resolution? Describe The Process?

52.What Is Edc?

53.What Is Rdc?

54.What Is The Scope Of 21cfr Part11?

55.What Does Part 11 Describe?

56.What Does Subpart B Describe?

57.What Does Section 11.2 Describe?

58.What Is an Act?

59.What Is Biometrics?

60.What Is An Electronic Signature?

61.Define Closed Systems?

62.What Do 11.50 Of Part 11 Deal With?

63.What Are The Codes Of Ethics To Be Followed By The Cdm Professionals?

64.What Is The Most Recent Version Of Gcdmp Document?

65.Who Is Gramp Meant For?

66.What Is External Data?

67.What Is Clean Data?

68.What Is The Purpose Of Cdisc?

69.List The Standard Models on CD?

70.What Is The Upcoming Model In Cdisc?

71.Describe Odm Standard?

72.What Is The Importance Of Lab Standards?

73.What Is Crt Dds?

74.What Are The 4 Types Of Data Required By Sdtm For Fda Submission?

75.What Is Metadata?

76.Differentiate Between Paper-Based Trials And Electronic Trials?

77.What Is The 21 Cfr For Good Manufacturing 21st?

78.What Is The 21 Cfr For Good Laboratory Practices (glp)?

79.What Is Sdv? When Is It Required?

80.What Is Aeros? What Is ItsIts Importance?

81.Define Uard?

82.Define Risk In Clinical Trial?

83.What Is Safety In Clinical Trials?

84. What Is Raw Data?

85.Who Are Vulnerable Subjects?

86.What Is Compliance?

87.What Is A Drug?

88.What Is A Patent?

89.What Are The Contents Of The 21 Cfr Part 58 For GLP?

90.What Are The Contents Of A Clinical Trial Protocol?

91.Who Is the Sponsor?

92.What Are The Products That Are Regulated By The Fda?

93.What Is A Cro?

So all these are important questions.

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