GREAT Registry (Follow-up)
https://clinicaltrials.gov/ct2/show/NCT01658787
What is being investigated?
GORE aortic products for abdominal aortic aneurysms.
Who is the PI?
Dr. Mendes
Who is the sponsor and/or CRO? How to contact them?
Sponsor: Gore
CRO: Fortrea
Contact: Vance, Amanda amanda.vance@fortrea.com
Where to enter data and upload images?
EDC: iMedidata https://login.imedidata.com/login?service=https%3A%2F%2Fwww.imedidata.com%2F
Images: NA
eTMF: NA
Upcoming Visits
This is a registry with contiguous follow-up windows. This means that there are no "out-of-window visits", any visit they come in for can be matched into one of the windows.
this is up to date as of 05 June 2023.
Tips/Quirks
Back up coordinator: Soumya Sidana
This is a rather disorganised study. The sponsor/protocol has very vague definitions on what is required or expected. Monitoring has been loose (I don't think they ever monitored).
My suggestion is - do your best with it, try to keep an eye out for patients who come in for follow-ups, report AEs as you get notified about them, etc. Do NOT be a perfectionist with this study.
Rebecca is aware that this study is disorganised and I think she is going to try talk with the sponsors to see if we could end early. All this is to say - speak with her if you have any concerns about this study, she knows it is a challenging one to manage.
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