This will depend on the specific study. Sometimes they ask CRAs to close out system queries when they can and sometimes they say to please leave them for DM review. There's no general rule.
Interactive Web Response System (used to manage drug), Electronic Data Capture (used to enter data) and Clinical Trial Management System (used for many things including maintaining site lists, contacts, writing reports etc.). Glad you like the videos.
If the person is new to Oncology and as they have so many things that needs to understand terminology and also like RECIST. And how do you prepare for site and what are the things needs to understand in protocol. Like usually main focus as CRA is on Inclusion exclusion Schedule of assessment end points And prohibited medication 💊..
Hi, how would you write a query in this scenario where the exclusion criteria exclude any subject with surgery 6 months prior to screening data and the clinical site has screened and randomised a patient who had leg surgery 3 months prior to this screening? Can you tell me exactly how to issue this query?
For inclusion/exclusion criteria not being met, you first want to bring it to the attention of the study team. The only thing you might want to query (assuming you're not on-site and looking at the source) is "please confirm that data for leg sugery being done 3 months is correct as entered." If you're on-site, you need guidance from the study team. This subject will likely be withdrawn from the study and your query should be explicit with their instructions. For example, "per source, leg surgery was done 3 months prior to screening. If data is confirmed correct as entered, please withdraw the subject from the study as subject should be excluded from the study per protocol."
Thank you, Mario! Keep making the videos, it helps new CRAs!
Great, video, thank you!
It’s super helpful. Thank you so much for making amazing videos.
very helpful, thanks
Nice video as always !
your videos are very informative, thank you Mario
Can a CRA close system queries?
This will depend on the specific study. Sometimes they ask CRAs to close out system queries when they can and sometimes they say to please leave them for DM review. There's no general rule.
what is the difference between IWRS, EDC and CTMS. Thank you for the videos. Really helpful
Interactive Web Response System (used to manage drug), Electronic Data Capture (used to enter data) and Clinical Trial Management System (used for many things including maintaining site lists, contacts, writing reports etc.). Glad you like the videos.
@@MarioDeSouza Thank you for your response. Very helpful.
I have a question how to write a query as data manager?
I think all the same concepts apply for DM. Don't lead the sites. Clearly state what is the issue, why it may be incorrect and ask the site to verify.
Can this be the same way for Clinical Data Managers as well?
Yes, all the same principles for query writing would apply to the CDM role as well.
Hey can you make video for entry level CRA for oncology studies
Sure. Anything specific about them you'd like me to cover?
If the person is new to Oncology and as they have so many things that needs to understand terminology and also like RECIST. And how do you prepare for site and what are the things needs to understand in protocol.
Like usually main focus as CRA is on
Inclusion exclusion
Schedule of assessment
end points
And prohibited medication 💊..
Hi, how would you write a query in this scenario where the exclusion criteria exclude any subject with surgery 6 months prior to screening data and the clinical site has screened and randomised a patient who had leg surgery 3 months prior to this screening? Can you tell me exactly how to issue this query?
For inclusion/exclusion criteria not being met, you first want to bring it to the attention of the study team. The only thing you might want to query (assuming you're not on-site and looking at the source) is "please confirm that data for leg sugery being done 3 months is correct as entered." If you're on-site, you need guidance from the study team. This subject will likely be withdrawn from the study and your query should be explicit with their instructions. For example, "per source, leg surgery was done 3 months prior to screening. If data is confirmed correct as entered, please withdraw the subject from the study as subject should be excluded from the study per protocol."
@@MarioDeSouza thank you
How can I reach you
Email: theclinicalresearchguy@gmail.com
@@MarioDeSouza I contacted you in your email. Thank you
Can a CRA close system queries?