Monitor access to medical records – confidentiality agreements

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      Hi all,

      The Medicines Australia Clinical Trial Agreement template has provisision for the sponsor or delegate to perform monitoring and each party and their personnel must not disclosure confidential information. We are finding that some sites are asking clinical trial monitors to sign additional confidentiality agreements to get access to medical records, in some cases police checks have also been requested. Monitors signing confidentiality agreements in their own capacity seems to be uncessaery given the CTRA covers confidentilaity, and for some sponsors, against their policy. I’d be interested ot hear if anyone else has come across this and how it is handled.



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