Study Tagging Files: What’s the Right Duration for Study Metadata?

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When submitting nonclinical study reports in regions using Study Tagging Files (STF), the duration of the study is one common piece of metadata that must be provided. The ICH eCTD STF Specification provides three options to choose from – short, medium, and long. But the ICH eCTD STF Specification doesn’t define the time periods covered by these three duration options.

Needless to say, our clients frequently ask us to help them determine which option is the correct choice for a given study. This is difficult to answer given the lack of definition, and I’m not aware of any guidance documents that address the question.

I posed this question to Phil Norwood, one of Synchrogenix’s nonclinical Subject Matter Experts. Phil agreed that there’s precious little information available to provide any guidance on this topic. However, based upon his many years of experience in this field, he recommends the following ranges as a rule of thumb for each of the study duration options:

  • Short is less than 1 month
  • Medium is between 1 and 6 months
  • Long is greater than 6 months

Have other questions regarding Study Tagging Files or eCTD submissions? Email Synchrogenix at contactus@synchrogenix.com.

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Author: Evan Richardson

Evan Richardson brings over 10 years of experience in regulatory affairs and operations to Synchrogenix. His experience includes stints with pharmaceutical, biotechnology, and medical device companies, where he's specialized in project management, system implementation, eCTD submissions and organizational training.

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