Hello,
We are currently thinking of oursourcing some of our technical
services for clinical trials (e.g. Sterile prep IMPs and
radiolabelled)and I wanted to check where we stood regarding
declaring this on any clinical trial applications. We currently are
working under the section 37 exemption and therefore the Trust is
declared on the IRAS form, however if the services were outsourced,
would we need to declare the outsourced provider? The provider has
an MA(IMP) and is fine from a regulatory standpoint, it's purely
whether there is a regulatory requirement to declare them as they
will be doing the labelling and final release (rather than the
Trust)and if so where we need to declare it.
Any help or thought would be greatly appreciated.
Many Thanks
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L Watson
Lemming12@live.co.uk
NHS
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