Need some clarity on eCTD module 5 [Regulatives / Guidelines]

posted by jag009  – NJ, 2024-07-12 18:04 (195 d 17:15 ago) – Posting: # 24071
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Hi,

Sorry if this is off-topic but can someone shed some light on the following?

There is inadequate or incorrect use of Study Tagging Files (STF).
1) The following folders and its subsequent files in module 5.3.1.4 should be tagged, using the proper file-tag element under one applicable study:

bioananlytical report for compound A
bioanalytical report for compound B

Can someone share an example of how the above should be done?
thx
J

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