Are there any restrictions on disseminating statistical reports to investigators outside our organization who were involved in a clinical trial?
Although the third party licensing agreement requires both a Sponsor and a CRO to carry a MedDRA subscription, there are no restrictions on disseminating statistical reports to investigators outside your organization who were involved in a clinical trial. In this case, the intent is of a business nature and not to distribute the MedDRA terminology. The MSSO realized that MedDRA codes sometimes appear in this data.
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