Individual patient narratives are not required to be in the IB. Inclusion of them should be considered on a case-by-case basis. For example, if a narrative description is helpful to provide context for serious AEs, including death, that are considered related to the investigational product, it could be included. However, it is clear that not all SAEs need a narrative.
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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: 11-Nov-2019 17:47
From: Tami Ujiie
Subject: IB and safety update
Thanks Victor.
I am asking this question on behalf of my friend.
I found a CIOMS document "Management of Safety Information from Clinical Trials" that recommends inclusion of Development Core Safety Information in IB, but my friend wants to know if there is any requirement or common practice relating to the inclusion of "patient narratives" in IBs.
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Tami Ujiie RAC
Senior Manager, International Regulatory Affairs
San Jose CA
United States
Original Message:
Sent: 11-Nov-2019 15:27
From: Victor Mencarelli
Subject: IB and safety update
As I understand you would need to let your IRB who is overseeing the study and the FDA know that there are new safety findings/signals. At that point I would expect that the IRB and/or FDA would expect you to notify the trial sites and cooperating investigators at these sites and any non-central IRB that might have some level of oversight. Remember there are some instances where you might have a centralized IRB handling the over-arching regulatory requirements for a study but individual institutions may, as SOP, have their internal IRB or preferred IRB also reviewing the studies. So I would think it might not be "written in the regulations" but I would suspect that it would be something you would be "highly encouraged" to do just in the course of running a study. My thoughts always were that people involved in an investigation had a right to be made aware of the actual current situation of the test material and whether there was any new information that might impact their desire to remain in the study. Remember - study participation is, by treaty, regulation and ethical requirement, a voluntary exercise. People without the full disclosure of risks and benefits cannot be seen reasonably to be "voluntarily" participating in anything.
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Victor Mencarelli
Director Regulatory Affairs
United States
Original Message:
Sent: 11-Nov-2019 00:03
From: Anonymous Member
Subject: IB and safety update
This message was posted by a user wishing to remain anonymous
When we become aware of new safety findings during clinical trials, is there any specific regulation for updating the narratives of the IB?