Great videos. Can you do a video on 'If I were an FDA Inspector/Auditor what areas would I look at during a Clinical Investigator or Sponsor/CRO inspection'
hey Mario i don't know if you remember we worked together for Janssen study PCR5001 study from IQVIA. It was totally a lovely experience working with you.
Thanks for the content. It is really helpful for me. I would like to know what books you would recommend for junior and aspiring CRAs to read to know and understand the regulations around clinical trials thoroughly.
The book I recommend is the Barnett Q&A guide to GCP/ICH. That's not only good for new/aspiring but also experienced CRAs. It's a book that you can keep re-reading as it goes from easy to complex.
I think Dan Sefra has some videos around that and they are worth checking out. I have extremely limited experience in the area so it would mostly be hypothetical.
A source worksheet is a tool that sites use to capture data. Any source needs to exist in original form out the Electronic Data Capture system so sites are provided with or, more commonly, develop their own source worksheets.
If you scroll through the videos, there are videos on the other visit types. I'll try and have a playlist available in the future to make the videos easier to find.
I’m starting as a CRA soon and this video is so so helpful I can’t thank you enough !!!
Great video!
Thanks a lot
Thank you so much! really helpful!
Loved this
thank you, Mario. Very useful video
Great videos. Can you do a video on 'If I were an FDA Inspector/Auditor what areas would I look at during a Clinical Investigator or Sponsor/CRO inspection'
hey Mario i don't know if you remember we worked together for Janssen study PCR5001 study from IQVIA. It was totally a lovely experience working with you.
Hi Sourabh, yes, I remember you from the Janssen study. It was a pleasure working with you as well. Hope you're doing well!
Thanks for the content. It is really helpful for me. I would like to know what books you would recommend for junior and aspiring CRAs to read to know and understand the regulations around clinical trials thoroughly.
The book I recommend is the Barnett Q&A guide to GCP/ICH. That's not only good for new/aspiring but also experienced CRAs. It's a book that you can keep re-reading as it goes from easy to complex.
@@MarioDeSouza Thank you very much
could you make a video about negotiation, contract, and budget? :)
I think Dan Sefra has some videos around that and they are worth checking out. I have extremely limited experience in the area so it would mostly be hypothetical.
@@MarioDeSouza thanks for the tip!
Could you elaborate on what a source worksheet is?
A source worksheet is a tool that sites use to capture data. Any source needs to exist in original form out the Electronic Data Capture system so sites are provided with or, more commonly, develop their own source worksheets.
This is very expository. Could you do a detailed video for other visits?
If you scroll through the videos, there are videos on the other visit types. I'll try and have a playlist available in the future to make the videos easier to find.
Thank God for you!! very helpful video