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Study Close Out FAQ's

Study Close-Out FAQ's

 

When can I close my study?

A study can generally be closed out if the below criteria are met:

  1. No subjects are currently being enrolled in the study.
  2. No subjects are currently receiving study drug, device or participating in any study activities.
  3. No data from medical records or databases is being obtained and/or shared with other individuals or organizations.
  4. No identifiable data are being analyzed.
  5. No subjects are being contacted by telephone or mail for purposes of follow-up.

Please note that all study data must be stored appropriately for a minimum of 5 years from the date the IRB office sends you notice that they have received your final report and the study is closed out. If the study is part of a larger grant or contract, this time-frame may be longer

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