As I interpret your questions -
With one IMP and multiple INDs, regardless of whether is because of multiple dosage forms or indications, you would submit the Medwatch, form and cover letter to all open INDs under which the active ingredient is being investigated.
With multiple IMPs and multiple sponsors, you would submit to the INDs of any IMP that was associated with the SUSAR under the protocol.
Similarly, you would notify all investigators conducting a protocol with an IMP that was associated with the SUSAR.
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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
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Original Message:
Sent: 10-Sep-2020 10:07
From: Anonymous Member
Subject: IND safety report submissions for IMPs with multiple open INDs & sponsors
This message was posted by a user wishing to remain anonymous
How do you handle IND safety report submissions for IMPs with multiple open INDs? Do you:
- Submit to the parent IND with a cross-reference to other open INDs in the safety report cover letter?
- Send the full safety report packet (Medwatch, form and cover letter) to the parent IND and only cover letter and form to other INDs?
- Send the full safety report packet (Medwatch, form and cover letter) to all open INDs?
- Other?
How do you handle IND submissions when there are multiple sponsor IMPs in the protocol? Do you:
- Submit to all of the open INDs for the IMP driving the reporting?
- Submit only to the IND of the IMP driving the reporting? Do you submit
- Submit only to the IND that the multiple IMP protocol was filed under?
- Other?
Do you notify all investigators for all sponsor IMPs in the protocol? Do you notify only the investigators of the IMP driving the reporting?