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4th Sep 2024, 05:04 PM
#1
PI Oversight of sponsor vendor staff for DCT Teleheath elements on a CTIMP.
There's a growing number of sponsors bringing telehealth components to clinical trial.
This brings with it a growing number of requests for a PI to have oversight of staff or multiple staff that a sponsors vendor may contract or sub contract to, for whom the PI has not met.
This brings with it an uncomfortable feeling. How can a PI sign off vendor staff from a sponsor, for whom they have not met, directly trained, assessed and felt competent for the study, yet is a mandatory component of the study.
There's DCT advice around, largely for the EMA and FDA, but under local guidelines, nothing particularly related to this area.
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