The Only Crash Course To Clinical Research You’ll Ever Need (full 5 hour OFFICIAL video)
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- เผยแพร่เมื่อ 31 พ.ค. 2024
- 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
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!!!
Thanks so much can I interview you?
@@dansfera yes you could actually, how would it work?
Just dm me LinkedIn or insta and lets make it happen!
Hey Calvin, congratulations. I am looking for a mentor in this field, can you help? Thanks
@@calvinonyemaechi8463 whats your ig or LinkedIn?
@ 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
Thank you! Much needed
Thanks 🙏
This should be pinned to the top
Thankyou, really helpful🤝
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.
Wow! That really means a lot. Thanks!
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!
This was of great help! Thanks so much, really appreciate it Dan.
Thanks a ton Dan...I am getting my basics clear👍🏻👍🏻
Thank you so much! I'm gonna watch an hour a day! this is great thank you for the resource :)
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
Thank you ❤️ good luck you’re making the right decision
Thank you Thank you Dan for sharing this Information !!! Very useful !!!!
Well put together, regular recaps.. A good value for data👍🏽
Thank you so much Dan . Just obtained the Good Clinical Practice certificate. Thank you once again.
Thank u Dan for your clear explanation.
I can't thank you enough!!! I stumbled upon these videos and am just so happy. These are phenomenal, Dan! Thank you for making these GEMS!!!
I appreciate you
Excellent material and presentation !!
This video is tremendously helpful, and I really appreciate how careful you are to be clear and repeat yourself! One question - is there any possibility of having captions added at some point in the future?
Hey Dan, this was so helpful! Thank you for breaking down CTs in a easy to understand way. Learned so much in a short time
Thanks so much Dan for this informative video. I am a pharmacist and this video is a good entry for me to this industry.. Thanks again for your time a effort to help people.
VERY HELPFUL. THANKYOU SO MUCH.
The most comprehensive course ever. I Read the book and now watching this video to reinforce my learning helps a lot.
Thanks Dan
Very important topic. Thanks for sharing
Good job , thank you for the information
tysm for this video! very helpful for new CRAs!
Great!! I was waiting for it. Thank you so much for every thing you do for the clinical recherche. I learn lot
I appreciate it very much thank you
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!
Glad i could help
Landed a CRC position with barely any experience using this video. It was so helpful!
Ayyye! That’s what I like to hear!
what was your pay then if you don’t mind me asking?
Great video looking up for further videos
Just got my copy of the book in. Thank you for all you do.
This video is loaded with informations.
Thank you.
Thanks, Dan for such a great presentation. It explained everything about clinical research in detail. I really appreciate it.
I appreciate you watching and commenting thank you. Please subscribe and like!
You have really taught it wonderfully...Dan...thanks for the course
❤️
Wow! Thank you! Half way watched this and already benefited. Taking my CITI courses as required for my new position as a CRN and so much of what you taught here as well as the content in your book and the info on your podcast has helped me so much. So Grateful
Thank you so much Dan. Quite Informative!
You're such a great teacher and I enjoyed every bit of this training. I ordered the book yesterday. Great job!
Thanks so much
Thanks for the class today
This has been incredibly helpful, all your videos are!
I appreciate it
Thanks a lot DAN . Really appreciate the efforts in imparting knowledge. It was amazingly informative.
Thanks a lot
thanks for you knowledge transfer
What a great video. Thank you. This is extremely helpful!
Thanks so much
Glad you put this information out there. I can't believe I watched the whole thing. I did watch it in FF for some parts, and then slowed it down when I needed to take notes. I got a job, and am using this to help train me up in what I need to know... remind me of what I am learning. Thank you!
love it....thank u...share it with a friend please!
Thanks a lot Dan! That is a wonderful overview.
So grateful and excited to come across this video. I am trying to achieve a career change from administration to clinical Research. I have a degree in Biochemistry, an MBA and PMI-PMP. Thank you Dan for this amazing video. Putting out my job applications and hoping to land an interview soon.
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 🙏🏼
Excellent effort!
Thanks for pursuing excellence
Thanks for watching
Well done prof!
Wow. Thank you so much Dan, you are amazing 👏 ❤. This video was absolutely helpful and very informative 👍.
Thanks so much
The best video on Clinical Research. What a great service. Thanks Dan
Wow. Thank you
A new subscriber from SG.Thanks a lot.😊
❤️
This video is loaded!💯 Thank you Dan.
Thank you
Hello Oluropo,
Hope you’re well ? Could you please tell me the best way to contact you . I have few questions I’d like to ask . Thanks in advance.
Thanks Dan, this is an invaluable overview for anyone interested in getting into or already working in the industry.
Thank you
Dan 🙏🏻 THANK YOU so much for all the efforts and your dedication , love for your work.
I appreciate that!
@@dansfera I am through my technical interview , definitely the credit must be shared with you. 🤝
Which company interview did you gave @priya ??
@@devendrajadhav390 May I ask why do you need this info?
Great job, thank you terribly
Thank you Soo much Dan. Your videos helped me alot to understand about clinical research.
🙏🏻
Thank you so much for the guidance that is so very needed and hard to come by. Its been put into an easy to understand format and in easily digestible increments. You sir are a god send! 💖
I appreciate it
I cant tell you how much I have learned from you! Thank you for making this useful video! You should do a TED on the dynamics of clinical studies!
Lol I am sure non clinical people would find that riveting 😂
Thanks so much! I appreciate.
Thanks 😊
You found your purpose. I'm impressed!!!
Corinne Lienou What do you mean? Can you please elaborate?
@@pseller4052 q
Thanks for the knowledge share
Dan, this is a really good video . I have only been a RNS for 5 months and this is so very helpful Thank you !👏
Thanks 😊
Hey Dan, such a great video! I got a lot from it.
I appreciate you
Thanks Amazing, definitely just found this video !
Glad you liked it!
Just stumbled upon your channel - my workplace linked your video as a resource to those of us who are new to clinical research! I learned a lot so thank you - from a fellow Latina in clinical research :)
Welcome to Guru Nation. The journey is the destination.
Nicely done. Simple and cleanly presented. Should be quickly understood by everyone. Kudos.
Thanks so much
Thank you for this video Dan! I recently received an offer thanks to your wisdom. Appreciate you sharing!
Fantastic!
Hi Dan,
I've been working as a Lead data manager, so basically from the CROs end, this was really informative with respect to what happens at the sites end. Makes me look at things from different perspective when it comes to the tasks that the site needs to perform. Thank you for this video very informative!
❤️
It's great course, thank you so much!
Thanks so much
I’m loving the audiobook! I’m only about an hour in but it’s great, thank you. Love that you go off script and discuss topics in more detail. I’ve been in research for many years-fantastic so far.
Thanks so much
Nicely explained Mr.Dan..it helped me while my CT course. Thanks
Thanks 😊
Hey Dan, Thank you so much for this! Cannot appreciate you enough.
Much ❤️
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.
Thank you so much Guru.
You're most welcome
thanks for these videos and books man
Thank you for supporting
This is such a great video. Very clear, easy to undersatnd with all the curcial information for clinical trial industry. Dan you absolute legend!!
I'm a data manager and I found myself hard to understand what is going on in sites for some data entry situation but with this now I get to know different function and it's verrrryyy helpful. I'm recommending this video to all my collegues!!!
Thank you!
@@jennytai4294 hey there! I am currently working as pharmacy technician and doing certification course in data analyst. I got an offer for CRC role. I was thinking of going for it and hopefully I can switch later into research analyst. Do you have any advice on that?
This is so informative and educational. Thanks a lot Dan for your effort in making this detailed one. I will definitely go to Audible book.
Thank you
I found this video as a fantastic way to wrap-up all the content after studying all the CRC materials. Before that, It would've been just too much info at once :D Thank you
Thank you for this video, so helpful
So glad!
This was great! Thanks!
Thank you
Great lecture, I gain alot
Dan, this is so good. Your teaching is very clear. I wish I had more teachers in my past like you. I plan to get your book too. I'm doing all of this learning to help me as a business analyst developing IT systems to support clinical research processes. To do that, I need to fully understand the business processes of CR.
Wow, thank you!
thank you very informative!
Juliet Wahome 🙏🏻
Great content! You really took the time and went through it all. The CRA typically reports directly to the CTM/CTL and they review their work. Line Managers manage metrics and employee productivity etc. Everyone gets a line manager, even the line manager has a line manager lol.
Who is the last line manager’s line manager? Comes back to the first like a serpent eating its tail 😂
Sir excellent work i pray to my God .I believe in Lord Sri vemkatehswara swamy . about your knowledge and God plese do good to him in future also every time
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!
I am so glad!
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.
Much ❤️
Awesome- and super simplified-wowww...I do a lot of FDA approved studies in South Africa as a PI-
Thank you
Thank you, Dan! I found your video and website so helpful. I am a pharmacist and my only work experience is in a community pharmacy. I have a 5 years gap in my career, during this time I moved to another country and had two kids, but I often felt discouraged and got the feeling that I lost the direction in my career. I've been looking for awhile for someone to explain thoroughly and accurate how do the things work in this industry and now I feel more optimistic and ready to open a door to Drug Development. 🙂
I’m very happy to hear. Keep me posted.
@ Daniela frunza have you pursued this direction instead of retail pharmacy?
We are always thankful to u sir and very fruitful class 🙂
😊
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!
You got this!
Thank you for the words of encouragement! Now that I am a few months into my CRC role I can say that it's been both very rewarding and challenging. I work in oncology at a large site and I mostly do data management. I keep coming back to the core principles that you cover in this video, and also I've been watching some of the other videos on your channel. Glad that I've found the content you've been putting out. It's all super helpful and I've definitely grown my industry knowledge over the last few months from watching. Thanks again!
It's great.It will be better to get a caption.Thanks DS that I know clinical trail more.
I've got the book, I'm almost done with my GCP . Thank You for all the knowledge you share with us! I hope to find a job soon
You can do it!
I am so happy I found your channel! You are great at explaining things! Question about how many CRC's are typically working together on one study?
1-3
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.
Excellent reminder
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!
Thanks so much!
Hello,
I am studying for the CCRC exam and have been a clinical research coordinator for almost 3 years. A lot of the information on Phases is new to me as I work on the tissue collection side of Biobanking. Thank you for this information
Welcome to Guru Nation
Great video dan. Thanks for sharing!
I just joined a BI Analytics project to pull clinical data in. The domain knowledge is totally new to me, but your video definitely helped out a lot.
Congrats!
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
I am so glad to hear that. Thank you so much.
Thanks!
thank you much appreciated
Been in clinical research now for 14+ yrs and "accidentally" stumbled into it back in 2008 after coming off maternity leave. Even after all these yrs I still have some knowledge gaps so loving your vid.
Thanks for sharing!
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.
That made my day thanks!
Michael oloche. Pls bro .How can I get internship program on CRA? Email me Luckyef@hotmail.com
I like this course.
thanks alot!!!
Thanks 😊
Thanks Dam! Keep it up and you will see me in class
You bet