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 [e-mail]

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.