My advice is to contact your CSO in advance to discuss data format (e.g. SAS transport file, Excel), regulatory format (CDISC/STDM, define.pdf), file and variable naming conventions (if not CDISC), as well as size.
It is also helpful to provide derived data as well so data alignment issues are headed off during review.
You might also consider sending your SAS code to produce analyses as well.
Good documentation always helps.
Most of the files that we submit exceed 900K MB so you are not creating any new issues.
------------------------------
Phil Lavin PhD, FASA, FRAPS
Principal
Lavin Consulting LLC
Framingham MA 01702 USA
------------------------------
Original Message:
Sent: 08-Dec-2018 14:55
From: Anne LeBlanc
Subject: Data set maximum size
Hello Anonymous
Not certain if I understand the question... The United States FDA ESG website shows statistics including upload times in minutes per GB: https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/AboutESG/ucm590817.htm
Also, the ESG Helpdesk is great about answering questions.
(ESGHelpDesk @ fda.hhs.gov)
------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States
Original Message:
Sent: 04-Dec-2018 09:46
From: Anonymous Member
Subject: Data set maximum size
This message was posted by a user wishing to remain anonymous
Hi All
I have a question on the maximum acceptable size of the data sets for the FDA. I remember that I read somewhere that the maximum size is 400 mg however, I have data sets of more than 900 mg that I need to submit.
Thanks