One of the most challenging, or dare I say confusing aspects of the eCTD is the organization and structure of the Study Tagging Files (STFs). Many ask the question "what exactly is required for STFs?
The quick answer is clarity. The FDA requires a logicial organization to be able to determine which files belong with which study. The more logicial you can arrange them, the better off your submission is. Recognized best practice is to establish a hierarchy with each study given a specific, unique number. This makes the submission easier to read and brings improved clarity to the overall submission.
Remember, clarity is the key to success with STFs!
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