The Only Crash Course To Clinical Research You’ll Ever Need (full 5 hour OFFICIAL video)
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- čas přidán 19. 05. 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!
This was of great help! Thanks so much, really appreciate it Dan.
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.
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
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
Thank you so much! I'm gonna watch an hour a day! this is great thank you for the resource :)
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 a ton Dan...I am getting my basics clear👍🏻👍🏻
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.
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?
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
The most comprehensive course ever. I Read the book and now watching this video to reinforce my learning helps a lot.
Thanks Dan
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
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!
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
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 Dan, this is an invaluable overview for anyone interested in getting into or already working in the industry.
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!
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
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?
Just got my copy of the book in. Thank you for all you do.
Thank you Thank you Dan for sharing this Information !!! Very useful !!!!
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
This video is loaded with informations.
Thank you.
Thank u Dan for your clear explanation.
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.
The best video on Clinical Research. What a great service. Thanks Dan
Wow. Thank you
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 😊
You have really taught it wonderfully...Dan...thanks for the course
❤️
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.
Thanks a lot DAN . Really appreciate the efforts in imparting knowledge. It was amazingly informative.
Thanks a lot
This has been incredibly helpful, all your videos are!
I appreciate it
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!
❤️
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 🙏🏼
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!
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?
A new subscriber from SG.Thanks a lot.😊
❤️
tysm for this video! very helpful for new CRAs!
Nicely done. Simple and cleanly presented. Should be quickly understood by everyone. Kudos.
Thanks so much
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.
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
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?
You found your purpose. I'm impressed!!!
Corinne Lienou What do you mean? Can you please elaborate?
@@pseller4052 q
Excellent material and presentation !!
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.
What a great video. Thank you. This is extremely helpful!
Thanks so much
Wow. Thank you so much Dan, you are amazing 👏 ❤. This video was absolutely helpful and very informative 👍.
Thanks so much
Excellent effort!
Thanks for pursuing excellence
Thanks for watching
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
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!
Thanks for the class today
Thank you Soo much Dan. Your videos helped me alot to understand about clinical research.
🙏🏻
Very important topic. Thanks for sharing
Hey Dan, such a great video! I got a lot from it.
I appreciate you
VERY HELPFUL. THANKYOU SO MUCH.
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 ❤️
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!
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
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.
Nicely explained Mr.Dan..it helped me while my CT course. Thanks
Thanks 😊
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 😂
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 for this video Dan! I recently received an offer thanks to your wisdom. Appreciate you sharing!
Fantastic!
Hi Dan, this was a really great introduction of the Clinical Research process. Really appreciate all the great work you have put in here. I was always confused on the work flows in the Clinical Trials but this video made things clearer with a clear flow of information. I was looking for Clinical Data Programming tutorials and fortunately landed here on your video. I was wondering if you could guide me in a proper direction for that, that would be very highly appreciated. I'm very interested in learning/understanding CDISC standards (SDTM and ADaM), and how we can use SAS on them to produce various analyses reports; not necessarily CZcams videos but can also be any training institute. Look forward to your advice. Thank you so much and again really appreciate the incredible work with putting all this information together.
Appreciate it
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
Great video looking up for further videos
Good job , thank you for the information
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
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!
thanks for you knowledge transfer
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?
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
hey! got a CRA interview today for entry level! finished your video one more time before the interview , especially the regulatory source and visits parts. thank you Dan!
Congrats!
@ezgi babacan, did you land the job?
@@calvinking3355 yes actually, it has been 3 full months as CRA :)
@@ezgibabacan2686 That's so awesome to hear! How are you liking it?
@@calvinking3355 It’s amazing really, even covid has a great impact on the role, it is still exciting & fun job
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
Hey Dan, Thank you so much for this! Cannot appreciate you enough.
Much ❤️
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!
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!
thanks for these videos and books man
Thank you for supporting
Oncology Clinical Research Assistant here! Hopeful CRA one day. Thank you for making this video. I found it very helpful.
you will be CRA it just takes time and effort!
Dan Sfera hi
Thanks a lot for this video . How can I attend your physical training?
@@dansfera 3 years later. I am a CRM and love being at the site level.
Thanks so much! I appreciate.
Thanks 😊
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
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!
Congrats 🍾 thats big time
Congratulations on obtaining your degree and getting a research position. I have received the same lucky break. I’m a new grad with a new COVID CRC position in Phoenix, Az. I was suppose to start the doctoral program this year, but decided to take a gap year to learn about research hands on. Best of luck to you!
Hey if you don’t mind, what kind of questions were asked on your interview?
@@loriehane5114
@@loriehane5114 Hi Lorie, can you more info on the school you plan to do your doctorate program?
Awesome- and super simplified-wowww...I do a lot of FDA approved studies in South Africa as a PI-
Thank you
Thanks Amazing, definitely just found this video !
Glad you liked it!
It's great course, thank you so much!
Thanks so much
It's great.It will be better to get a caption.Thanks DS that I know clinical trail more.
Hi Dan thank you so much for this insightful and detailed video!!! I'm completely new to the Clinical Research field, and I'm really excited to get into the industry. I've been working in the Pathology industry as a Medical Laboratory Scientist since 2015/2016 and specialised in Cytology (Cellular Pathology) which includes Molecular Pathology. As you may know the lab can be quite routine and monotonous and runs on a very strict TAT to get results out; but I've been learning alot, including QA and lab management. The Pathology industry is also a place where you have to wait 20 years for your manager to retire before you can move up.... unless your environment allows for development for you to create your own niche....
So I've been watching your videos and doing online GCP courses, preparing for a CRC interview. Most CRC posts that I've seen here in South Africa requires one to have a nursing degree. I've also applied for an in-house CRA post.
Questions:
As a CRC or CRA how much does one need to know about interpreting basic lab results and also on drug pharmacodynamics?
Do you offer any crash courses or can you recommend videos on interpreting basic lab results or drug pharmacodynamics?
I am planning a new book on this
You and I have the same story!
Well done prof!
is it possible to add subtitles? I think a lot of people would watch this video, you did an amazing job, thank you
Thanks a lot Dan! That is a wonderful overview.
Dear Mr Dan,
Thank you so much for this video! I'm so grateful to you! In spite of having no clinical research background, your video helped me to get the CRA position at the big one CRO (I'm not from an English-speaking country)!
Thank you for your work and your time!
All of your subscribers appreciate it so much!
P.S. I want to buy the book to better understand the entire process of Clinical Researches. I believe that this book is worth reading.
Wish you the best things!
hello Julie... lm trying ti become a CRA any tips of what to do to get me started. thank you
@@oladosusegun6892 Hello! It depends on lots of factors actually (country, work background, degree). I really advise you to watch videos on this channel. For this one, for example, I did lots of notes and learn them all. Re-watching is a good thing, as well. Plus, for more understanding, you can get Dan's book. It helps you to get the common sense of a CRA position. I don't know if you have any experience... If not, I advise you to find a CRC position first or a clinical trial assistant. Hope that it can help you a little.
@@juliej7589 l will look at everything you pointed out and try to get his book .... lf l need your help again for futher guidance. I will reach out . Thank you
Great job, thank you terribly
Thankyou for making this, very helpful and informative. Do you have a book dedicated to Pharmacovigilance and aggregate reporting? Also, would request you to make a similar video on these topics.
Thankyou :)
We are always thankful to u sir and very fruitful class 🙂
😊
Thank you so much for providing these free resources. I'm wondering if you would think this would he applicable to CCRP exam? It seems like it is based off what I've been watching you discuss so far but wanted to ask if there are maybe other resources you'd recommend?
Thank you for this video, so helpful
So glad!
Thank you so much Guru.
You're most welcome