Can you explain how flags work? I would love to implement those, but have never seen them in Cayuse HE.
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Daniel R. Kirienko, Ph.D.
Preferred pronouns: he, him, his
IRB Compliance Lead
Office of Research Integrity
Rice University| 350 Allen Center | 6100 Main Street, MS 16 | Houston, TX 77005
Tel: 713.348.3586
dk32@rice.edu------------------------------
Original Message:
Sent: 05-26-2023 07:03
From: MK Karafonda
Subject: FDA Inspection/Survey with HE
Having asked my colleagues, the recommendations center around giving the auditor specifically what they ask for via printed materials or PDFs on a flash drive, rather than giving blanket access. This keeps the focus solely on the requested information. If you're using flags, flagged FDA studies can be identified via reporting.
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MK Karafonda
Sr Product Manager
Cayuse
Original Message:
Sent: 05-23-2023 14:37
From: Anonymous Member
Subject: FDA Inspection/Survey with HE
This message was posted by a user wishing to remain anonymous
Has anyone gone through or experienced a FDA Inspection/Survey? How did you showcase Cayuse HE to the inspector, narrowed which studies were FDA studies, etc? Did you download everything on a flashdrive drive for them? Provided them a Cayuse account?