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16th Feb 2021, 07:06 PM
#1
Same person acting as both sponsor AND site staff - inappropriate?
Hi all,
I would appreciate your thoughts and experience on having the same person acting as TM for sponsor and TC for site (and potentially entering data too)? This means being on both site and sponsoir delegation log.
It doesn't seem appropriate in my eyes having access to both trial management and patient identifiable data....but this is the way our organisation is moving. We are mainly CTIMPS.
I understand staff resources are a factor, but I would have thought it is a practice to be discouraged, especially for CTIMPS.
I have asked our GCP team but there are being non commital, presumably as there are no specific regulations regarding this.
Thank you,
TrialsAdvice
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