The Only Crash Course To Clinical Research You’ll Ever Need (full 5 hour OFFICIAL video)

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

[calvinonyemaechi]

So I have been rewatching this video for one whole month. I also bought the book and have been dissecting that as well. I’m just one month I landed a CRC position from the knowledge I got from Dan. I have absolutely no experience but I literally watched all of Dan’s videos for knowledge, terminology and confidence going in. Just wanted to state that for anyone looking for guidance into getting in clinical research. Thank you for alll your work Dan!!!

[AnupamBam]

@ 1:24 - Overview of the clinical trial ecosystem
@1:18:49 - Clinical trial phases
@1:42:32 - Regulatory aspects
@2:35:32 - Source documents
@3:15:21 - Study visits
@3:37:53 - Monitoring visits - overview
@3:48:07 - SDV/SDR
@3:55:02 - Individual monitoring visits
@4:16:38 - Career trajectory

[christinerose]

Ive been in Clinical research for 11 years and have never heard it broken down like this. THANK YOU for taking the time to do this! Chipping away an hour a day and taking notes. Just when you thought you knew it all.

[ataelbizanti]

Wow honestly these are the moments I forgo every bad thing about the Internet and see it as truly a miracle. I just completed my masters working in pre clinical research and going into the typical PhD route but started to feel like perhaps a career in clinical research is equally as fulfilling given I had a bit of experience as an undergrad, but I still felt like it’s not my place, and here I am now making coffee and feeling like I just started a new master’s. Thank YOU thank YOU will be commenting again when I hopefully land my first step in this field and you will be acknowledged

[beautywellnessbydestini]

Landed a CRC position with barely any experience using this video. It was so helpful!

[tasnimfarzana]

I'm completely new to clinical research and I just got hired as a CRC. Your comprehensive videos gave me such a great overview and understanding of clinical research that was extremely crucial for my new position. Not only does this video give a good overview of research as a whole, but it also gives clear explanation on every detail about research! This video helped me out big time, Thank you!

[thissssssunnn]

Hey Dan, just wanted to say thank you so much for this video. I actually just graduated with my Bachelor's degree a few weeks ago and I was fortunate enough to land a CRC position with no prior clinical experience. This video really lent me some amazing introductory knowledge and terminology for my first day at the job, so I know what's going on. Very grateful!

[AlongSamXiong]

The fundamental clinical research knowledge this video bestows upon you is so valuable! Whether you are coming from a place with clinical research experience or not, understanding the clinical research ecosystem will allow you to climb/grow so much faster in this industry! I jumped into this field about 7 months ago and it's crazy how applicable this knowledge is in my every day tasks.

[seanwang]

I'm currently interning at a biotech company with many products in the late stages of the clinical trial phases and this video was able to teach me SO much that I needed to know! Now I am able to understand what my colleagues are talking about! Thank you!

[DrAyeshaJB]

Took me 3 weeks to get through this video (taking notes, going back to things, theres a lot packed in!) But so worth it! Now onto GCP and IATA. Thank you for your hard work Dan 🙏🏼

[RachelleMD]

I officially begin my career in CR next week as a CRC! Thank you so much for this video, you are amazing and I appreciate the way you break everything down! Thank you Dan!

[hibaal-khadraa]

Thank you so much Dan, I have been a CRC for 2 years and by watching your video I have all the dots connected regarding a full complete clinical trial. You basically answered all my questions in a very simple informative way You R AMAZING

[priscamaduka]

So grateful I stumbled on this video. It is all I have ever needed to get adequate insight for an entry into clinical research. Good work Dan!

[marissavillegas]

Subject-specific reports to the IRB, e.g. protocol deviations, and IRB's response/acknowledgement also goes in the source files. Easier for study monitor to determine and review if a deviation that was discovered during an interim visit has been reported to the IRB.

[yingliu]

This is amazing! I am a graduate student with background in pharmacy and public health. Basically I am a professional. But I cannot tell you how much I learned from this video! So informative and clear! Well done, Dan!

[syeduzair]

The best video on Clinical Research. What a great service. Thanks Dan

[michaeloloche]

Thank you Dan, and Happy Father's Day. You are my mentor. I was able to get into the clinical research industry after I watched one of your videos where you advised one to offer oneself for an unpaid internship position at a site. I did just that and I am a CRC today. Hoping to be like you someday.

[liacharlet]

Thank you for this great video! I have worked through it completely and have just received a job offer as an in-house CRA with no work experience. The line managers I had the interview with seemed pleasantly surprised and asked me "where I got all my knowledge from". I am sure that the holistic knowledge from this video helped me to get the job. I'm really looking forward to starting my career in clinical research.

[normadenisesaenz]

Your ability to explain is top tier 👌🏽

[seagull]

I just started a CRC role this week and I've been watching this video over the last few days to reinforce what I've been learning in my training. Super helpful!