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How Often Do Clinical Trial Registration Records Need to Be Updated?

FDA-regulated research must be updated at least once every 12 months with the dates of the changes indicated. If there are any changes in recruitment status or if the study is completed, information must be updated within 30 days of that event.

On the other hand, ICMJE requires information be updated every six months.

Therefore, in order to be compliant with both the FDA and ICMJE, at Dartmouth you must:

  • Update registration records every six months with dates of changes indicated
  • Update records within 30 days of any enrollment status changes or study completion
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