[COLOR="#0000CD"]One of the sponsor refused to supply QP release certificate with the IMP shipment. Is it OK to go ahead or we definitely need it. But QP issued a letter stating that all trial related doucuments are kept with sponsor files.[/COLOR]
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[COLOR="#0000CD"]One of the sponsor refused to supply QP release certificate with the IMP shipment. Is it OK to go ahead or we definitely need it. But QP issued a letter stating that all trial related doucuments are kept with sponsor files.[/COLOR]
Within the terms of the legislation only the sponsor requires to hold the QP certification, therefore, unless your organsiation is the sponsor, you do not require to have the QP certification (although it is good to have if the sponsor provides it.) If the QP has issued a letter confirming it is in place and held by the sponsor, this is acceptable to investigator sites for their files.