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CRF DESIGNED ACCORDING TO SOP 8.0 CASE RECORD FORM DESIGN

CRF Design and Approval Process Map for Trials Sponsored by King’s Health Partners Organisations. Clinical Trials sponsored or co-sponsored by Partner Organisations only ?. YES. NO. CRF DESIGNED ACCORDING TO SOP 8.0 CASE RECORD FORM DESIGN. YES.

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CRF DESIGNED ACCORDING TO SOP 8.0 CASE RECORD FORM DESIGN

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  1. CRF Design and Approval Process Map for Trials Sponsored by King’s Health Partners Organisations Clinical Trials sponsored or co-sponsored by Partner Organisations only? YES NO CRF DESIGNED ACCORDING TOSOP 8.0 CASE RECORD FORM DESIGN YES CRF Design delegated to Partner Organisations? NO Interdisciplinary Review by ALL involved with the CRF design (At minimum: Chief Investigator and Trial Statistician) SOP 8.CRF Design not applicable Review of the CRF designed by non-Partner Organisation (At minimum: Chief Investigator) Document Approval on CRF Review and Approval Form CRF approved by email CRF APPROVED & PRINTED CRF amendment as required in line with protocol amendments

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