PowerPoint Presentation - Rochester, NY...sign, symptom, or disease temporally associated with the use of a investigational product or Other protocol-imposed intervention, regardless

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REINTERATE THE RESOURCE YOU USE IS THE CTCAE

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Lung ventilation perfusion scan typically used to diagnose a pulmonary embolism

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STATE WHOSE ROLE IT IS TO ASSESS AES –provide the instructions from the protocol so that it’s consistent with study specific definitions

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LEAD WITH HERE ARE 2 LOCAL IRB EXAMPLES OF AE POLICES. 1) RSRB AND 2) WIRB

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GIVE EXAMPLES OF EACH OF THESE OR AS TIME PERMITS, ASK THE ATTENDEES IF THEY HAVE ANY EXAMPLES TO SHARE.

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