Hi Vasundhara,
I am not sure what mitigation actions you refer to, but I am not aware of any hard line on when a financial disclosure becomes a disqualifying factor. Many considerations will make the assessment of conflict of interest more or less of a concern. For example, number of other investigators and overall contribution of the investigator, objectivity of the study endpoints, whether the study is blinded, etc. When I have had an investigator with an apparent conflict, I have addressed in a statement signed by the investigator declaring that in their opinion conflict did not influence how study data was managed.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 07-Jul-2021 21:27
From: Vasundhara Pathak
Subject: Investigator's positive financial disclosure
Hi all,
When do you consider Investigator's positive financial disclosure as a concern. If the mitigation actions have been taken is it fine to include investigators with positive financial disclosure (>25k)?
Thanks