Transcription of Study Start-Up SS-204.01 STANDARD OPERATING …
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Study Start-Up SS-204.01 STANDARD OPERATING …
SOP For Site Initiation Visit Effective date of version: 01 April 2012 Replaces previous version : 01 June 2010 Georgia Center for Oncology Research and Education Page 1 of 15 Study Start-Up STANDARD OPERATING PROCEDURE FOR Site Initiation Visit (SIV) Approval: Nancy Paris, MS, FACHE President and CEO 08 March 2012 (Signature and Date) Approval: Frederick M. Schnell, MD, FACP Chief Medical Officer 09 March 2012 (Signature and Date) Issue Date: 01 April 2012 Effective Date: 01 April 2012 Expiration Date: 01 April 2014 Document Review Date: 01 February 2012 Primary Author: Anita Clavier, BSN, MPH Reviewer: Joni N. Shortt, RN, BSN, CCRC SOP For Site Initiation Visit Effective date of version: 01 April 2012 Replaces previous version: 01 June 2010 Georgia Center for Oncology Research and Education Page 2 of 15 I. INTRODUCTION AND PURPOSE This STANDARD OPERATING procedure (SOP) describes the processes followed by Georgia CORE when conducting a Study initiation visit to: Prepare site personnel to implement the protocol according to GCP requirements, Review Study drug administration and accountability, Provide instruction in any specialized procedures such as tissue collection, diagnostic tests and special computer programs, Provide direction for CRF completion.
SS-204.01 SOP For Site Initiation Visit Effective date of version: 01 April 2012 Replaces previous version: 01 June 2010 Georgia Center for Oncology Research and Education
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