The simple answer is yes. The safety information should be provided to the sponsor from the investigator at the completion of use or as agreed as a condition of providing the product for its intended use. The sponsor should submit the safety information as part of the DSUR or PSUR depending on the status of the product being used. If there are clinical data that are relevant, sponsor's often include these data as anecdotal, for completeness and transparency. Because the clinical data are not from the sponsor's well controlled study, the data generated by the investigator is not part of the sponsor's data set.
Best,
Dar
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Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
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Original Message:
Sent: 11-Apr-2022 01:54
From: Anonymous Member
Subject: DSUR - Inclusion of Emergency use/Single Patient INDs
This message was posted by a user wishing to remain anonymous
Hi All,
For DSUR preparation - Do sponsor (commercial) has to include information of Emergency use/Single Patient INDs conducted by Investigator in DSUR.
Please guide/provide your inputs.
Thanks in advance.
Regards