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Posted by John Lehmann on Wed, Mar 04, 2015

What’s the Best Way to Disclose Conflict of Interest?

Conflict of interest can be defined as occurring when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other.  Per the regulations, most clinical trials require disclosure of conflict of interest (COI). This is required by the investigator(s) to the sponsor, then from the sponsor to the FDA. The FDA then considers whether adequate steps are taken in the design, conduct, reporting and analysis of studies to minimize bias.

Topics: Conflict of Interest, 21 CFR 54, FDA

Posted by Sandra Maddock on Wed, Mar 04, 2015

Where is EMA Falling Short? See Audit Results!

Conflict of interest can be defined as occurring when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other.  While many may see disclosure of conflict of interest as just another form to check off the list, it’s an important aspect in a study to ensure the trial is conducted with the utmost integrity and responsibility.

Topics: Conflict of Interest, EMA, FDA

Posted by John Lehmann on Wed, Mar 04, 2015

New FDA Guidance: How Best to Disclose Conflict of Interest

Conflict of interest can be defined as occurring when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in the other.  Per the regulations, most clinical trials require disclosure of conflict of interest (COI). This is required by the investigator(s) to the sponsor, then from the sponsor to the FDA. The FDA then considers whether adequate steps are taken in the design, conduct, reporting and analysis of studies to minimize bias.

Topics: FDA Guidance, Conflict of Interest

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