Clinical Study Protocol not a amended

Home Forums Where do I file…. ? Clinical Study Protocol not a amended

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      Lucy Ridley

      Hi All,
      Please can you advise how where to file an amendment of a Clinical Study Protocol after the decision of not amending it ? Usually draft copies are not filed only the final document, but this is an unusual situation and from an Inspection point of view would need to file this and document the decision making process and the close out activities related to this.

      Many thanks


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