The Only Comprehensive Guide To Clinical Research You’ll Ever Need (full 5 hour crash course) v.2019 (Make sure to watch in 1080p to avoid the lip sync lag)

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Timepoints

00:00 Intro To Crash Course To Clinical Research

02:24 Bird’s Eye View of Clinical Research

03:21 What/Who is a Sponsor?

04:09 Types of Sponsors

05:02 Intro to Clinical Trials, Phases and Sites

09:04 Research Protocols

10:08 Who Works at Investigate Sites?

11:24 Contract Research Organizations (CROs)

15:27 FDA, GCP, IRBs and Ethics

23:10 What are Vendors and Electronic Data Capture (EDC)?

29:16 Clarifying Private Vs Academic Sponsors

35:54 CRCs and CRAs The Backbone of Clinical Research

43:37 What Do CRCs Actually Do? (1)

47:53 Intro to Source Documents

49:30 What Do CRCs Actually Do? (2)

53:41 What is ALCOAC?

1:01:00 What Do CRAs Actually Do?

1:08:24 How Do You Become a CRA?

1:15:29 What Are Other Entry Jobs At Sites?

1:16:58 Lead CRAs & Line Managers

1:18:49 InDepth View: Clinical Phases; Phase I

1:23:48 Phase II Studies

1:30:02 Phase III Studies

1:40:11 Phase IV

1:44:22 ICH Principles Cornerstone of Clinical Research Ethics

1:59:31 Training, Certificates & More Practical Aspects

2:04:16 Regulatory Startup

2:15:26 Regulatory Maintenance

2:22:52 Protocol Amendments

2:27:20 What Does AEs, SAEs & SUSAR Mean?

2:36:05 InDepth View: Source Documents

2:41:30 What is Informed Consent?

2:50:44 Two Clinical Aspects to Rule Them All

2:51:43 Medical History

2:56:19 I/C CRITERIA & Subject Confidentiality

2:59:44 InDepth View: Adverse Events (AEs)

3:07:48 What Does ‘Breaking The Blind’ Mean?

3:09:22 Protocol Deviations

3:13:08 Schedule of Assessments

3:15:21 What Are the Types of Clinical Research Visits?

3:21:03 Visit 2/Randomization

3:28:28 Routine Study Visits

3:32:48 What Can Site Do To Reach Patients?

3:34:52 Screen Failure

3:37:53 Intro to Monitoring Visits

3:48:06 InDepth View: SDV/SDR

3:55:01 InDepth View: Monitoring Visits

4:16:38 OUTRO