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 ALCOA-C?
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 In-Depth 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 Start-up
2:15:26 Regulatory Maintenance
2:22:52 Protocol Amendments
2:27:20 What Does AEs, SAEs & SUSAR Mean?
2:36:05 In-Depth 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 In-Depth 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 In-Depth View: SDV/SDR
3:55:01 In-Depth View: Monitoring Visits
4:16:38 OUTRO