Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear Forum-

We have a situation that I haven't previously encountered.  In a clinical trial, an SAE occurred due to hospitalization, but the patient has not released the medical records to the clinical site.  The principal investigator believes it will be unrelated however he cannot give a causality until he reviews the hospital records.  If the records won't be released and a causality cannot be determined due to lost to followup, how is this reported to the FDA?

Thank you for your guidance.

When the investigator is unwilling or unable to provide causality based on the circumstances and there is not enough information for the Sponsor to assess causality, it is common practice to assume the event is related.  If that makes the event a SUSAR, then it should be reported as a 15-day report.

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Glen Park
Jersey City NJ
United States
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Original Message:
Sent: 23-May-2018 14:14
From: Anonymous Member
Subject: IND expedited reporting

This message was posted by a user wishing to remain anonymous

Dear Forum-

We have a situation that I haven't previously encountered.  In a clinical trial, an SAE occurred due to hospitalization, but the patient has not released the medical records to the clinical site.  The principal investigator believes it will be unrelated however he cannot give a causality until he reviews the hospital records.  If the records won't be released and a causality cannot be determined due to lost to followup, how is this reported to the FDA?

Thank you for your guidance.