IMP Transfer from one study site to another

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Also, of course a risk assessment on the IMP itself. The QP will want to assess whether the IMP still remains inside specification before transferring to another site (as per Annex 13 above). Hence your SOP will need to include this assessment and whether IMPs that are more sensitive (such as those with only limited stability data, or those which need special handling , such as cool chain IMP) would be unlikely candidates for inter-site transfer.