Thanks Dan, so what is the difference between an electronic trial master file and a clinical trial management system? Is the eTMF a type of CTMS? If yes, what other types of CTMS are there? To my understanding, both the eTMF and the CTMS are used to collect, store and streamline the access to every non clinical information of your trial. What about clinical data? Where is this stored? Why can't both databases (non clinical and clinical) not be integrated into one? To be honest I am confused about all the eclinical solutions terminology (EDC, CTMS, CDMS, RTSM (randomised trials supply management), eCOA, eTMF...). How do they all fit together? What is the big picture...How does an integration of those solutions look like? What goes with what? What is complementary to what, what is supplementary of what? And we talk about systems and data storage files, but what are the different type of data types that can be stored? (can we store social media data, omics data, wearable devices' data etc..) What are the limitations? Sorry it is a lot of questions! My confusion can easily be spotted, I have so many questions... Would really appreciate a response, thank you very much!
Awesome video! Thanks for the info!
Trial master file,/Regulatory binder/1572
Nice recommendations
Thank you I was looking for a video like this.
Glad you found!
Financial disclosure need to be discussed on 2021 too, many forget here 🎁
Thank you, Dan. excellent video! would you please some clinical trial document management softwares?
Will try thank you
Master file is a video?
Excellent video!
Thanks so much
Thank you Dan for explaining TMF but where we put source documents or clinical documents like labs and Rx or MRI results ?
In patient source chart
Hey Dan - is the FDA 1572 form needed for all studies? I'm reading it's not needed for some studies. Can you please clarify
Yes and no 😂 depends on sponsor. 95% of time yes
very helpful video
So happy to hear
thank you! great lessons~ from Korea Quintiles CRA junior
Iqvia
nice explanation
Thanks
What is PAS?
Never heard
Full form of PI?
PI full form is Principal Investigator
very well explained!
Parul Sanghi thanks
Thanks Dan, so what is the difference between an electronic trial master file and a clinical trial management system? Is the eTMF a type of CTMS? If yes, what other types of CTMS are there? To my understanding, both the eTMF and the CTMS are used to collect, store and streamline the access to every non clinical information of your trial. What about clinical data? Where is this stored? Why can't both databases (non clinical and clinical) not be integrated into one? To be honest I am confused about all the eclinical solutions terminology (EDC, CTMS, CDMS, RTSM (randomised trials supply management), eCOA, eTMF...). How do they all fit together? What is the big picture...How does an integration of those solutions look like? What goes with what? What is complementary to what, what is supplementary of what? And we talk about systems and data storage files, but what are the different type of data types that can be stored? (can we store social media data, omics data, wearable devices' data etc..) What are the limitations? Sorry it is a lot of questions! My confusion can easily be spotted, I have so many questions... Would really appreciate a response, thank you very much!
Ctms is essentially a way to keep track of studies at the cro level.