SOP02V3 SOP for establishing and maintaining a TMF - Accord
SOP02V3 SOP for establishing and maintaining a TMF - Accord
SOP02V3 SOP for establishing and maintaining a TMF - Accord
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ACCORD/ECTU<strong>SOP</strong> Number: ACCORD/ECTU/<strong>SOP</strong>02/3.0NHS Lothian <strong>and</strong> Version: 3.0The University of Edinburgh Effective Date: 27/10/20085 Research Team – Staff <strong>and</strong> Training• Signed/dated CV of Investigators, Sub-Investigators, Pharmacypersonnel• Delegation log6 Monitoring <strong>and</strong> Audit• Risk assessment <strong>and</strong> monitoring plan• Monitoring reports• Monitoring correspondence (including telephone reports, followupletters etc)• Trial initiation monitoring visit (if applicable)• Consent Log• Final close-out monitoring visit report• Audit certificate• Clinical trial report7 Laboratories• Accreditation of all labs used (<strong>and</strong> updates)• Normal value references <strong>for</strong> all labs used (<strong>and</strong> updates)8 OtherCase Report Forms• Sample copy of CRF (<strong>and</strong> any previous versions) if not already inthe protocolGeneral correspondenceControlled Document – Do Not CopyPage 8 of 8
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