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Udemy - Clinical Trials - A Complete Guide For Professionals

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1 - Introduction To Clinical Trials

1 - What Is A Clinical Trial.mp4

MP4

32.3 MB

10 - Regulatory Submissions

11 - Course Summary And Next Steps

2 - Phases Of Clinical Trials

3 - The Clinical Trial Protocol

10 - Protocol Amendments When Plans Change.mp4

MP4

67.3 MB

4 - Key Roles And Responsibilities

11 - The Sponsor Owning The Trial.mp4

MP4

40.6 MB

12 - Contract Research Organizations Cros.mp4

MP4

28.1 MB

13 - The Principal Investigator And Site Staff.mp4

MP4

34.3 MB

14 - Regulatory Authorities Fda Ema And Beyond.mp4

MP4

38.6 MB

15 - Irbs Ethics Committees And Dsmbs.mp4

MP4

66.2 MB

5 - The Regulatory Framework

16 - Ich E6 Gcp The Gold Standard.mp4

MP4

54.4 MB

17 - Fda Regulations Us Framework.mp4

MP4

44.9 MB

18 - Ema The Clinical Trial Regulation And Global Landscape.mp4

MP4

42.3 MB

19 - The Trial Master File Tmf.mp4

MP4

40.9 MB

20 - Getting A Trial Authorized Ind Cta And Clinical Hold.mp4

MP4

82 MB

6 - Trial Operations Startup To Closeout

21 - Site Selection Qualification And Initiation.mp4

MP4

57.8 MB

22 - Patient Recruitment And Informed Consent.mp4

MP4

43.8 MB

23 - Randomization Blinding And Unblinding.mp4

MP4

93.5 MB

24 - Monitoring Sdv Rbm And Site Visits.mp4

MP4

47.5 MB

25 - Protocol Deviations And Trial Closeout.mp4

MP4

97 MB

7 - Clinical Trial Systems And Technology

26 - Ctms The Trial Management Backbone.mp4

MP4

82.3 MB

27 - Edc Electronic Data Capture.mp4

MP4

27 MB

28 - Iwrsivrs Randomization And Supply Management.mp4

MP4

23.4 MB

29 - Etmf Medical Coding And Central Labs.mp4

MP4

15.2 MB

30 - The Integrated Ecosystem Safety Epro And Data Standards.mp4

MP4

187.2 MB

8 - Clinical Data Management

31 - Case Report Forms Design And Completion.mp4

MP4

91.5 MB

32 - Data Cleaning Queries And Validation.mp4

MP4

74.4 MB

33 - Database Lock The Critical Milestone.mp4

MP4

80.8 MB

34 - Statistical Analysis Plans And Clinical Study Reports.mp4

MP4

149.2 MB

9 - Safety Monitoring And Pharmacovigilance

35 - Adverse Events Saes And Causality.mp4	MP4	94 MB
36 - Sae Reporting Timelines And Obligations.mp4	MP4	68.8 MB
37 - The Dsmb Independent Safety Oversight.mp4	MP4	77.5 MB
38 - Risk Management Plans And Signal Detection.mp4	MP4	143.6 MB

8 - What Is A Protocol And Why It Matters.mp4

MP4

46.5 MB

9 - Anatomy Of A Protocol Key Sections.mp4

MP4

86 MB

4 - Phase I Firstinhuman Studies.mp4

MP4

71 MB

5 - Phase Ii Proof Of Concept.mp4

MP4

42.2 MB

6 - Phase Iii Pivotal Trials.mp4

MP4

39.8 MB

7 - Phase Iv And Postmarketing Studies.mp4

MP4

76.4 MB

43 - Key Takeaways And The Clinical Trial Ecosystem.mp4

MP4

58 MB

44 - Your Next Steps In Clinical Research.mp4

MP4

69.1 MB

39 - The Common Technical Document Ctd.mp4

MP4

81.6 MB

40 - Nda And Bla Us Marketing Applications.mp4

MP4

86.1 MB

41 - Maa European Marketing Authorization.mp4

MP4

56 MB

42 - Ectd Electronic Submissions And Publishing.mp4

MP4

136.3 MB

2 - Why Are Clinical Trials Necessary.mp4

MP4

35.3 MB

3 - The Drug Development Lifecycle.mp4

MP4

51.1 MB

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Udemy - Clinical Trials - A Complete Guide For Professionals

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