thanks - that makes sense. Sounds like it is something that happens behind the scenes in publishing. I was thinking of data standards, which means something different to me, but I have mostly worked on later phase, clinical programs where much of the nonclinical work was already done!
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Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
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Original Message:
Sent: 02-Apr-2019 15:52
From: Ashley Clark
Subject: Study Data Standardization Plan
Hey Beth,
If I am understanding the question correctly, yes non-clinical studies are required to be in the eCTD format. These data standards are probably addressed by your publisher if you are utilizing one for your submissions. I believe this has more to do with how files are named for your upload. It's all the same content for m4, just formatting is different for final submission. Hope to start a dialogue!
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Ashley Clark RAC
Gainesville FL
United States
Original Message:
Sent: 27-Mar-2019 14:00
From: Beth Weinberg
Subject: Study Data Standardization Plan
Maybe I'm just out of the loop on this, but I was surprised to see nonclinical studies listed in the example Study Data Standardization Plan: https://www.fda.gov/downloads/forindustry/datastandards/studydatastandards/ucm447119.pdf
Is this a requirement? Our nonclinical CROs don't seem to know how to handle this.
thanks!
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Beth Weinberg
Regulatory Affairs Lead
Carmel IN
United States
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