cra monitoring visit checklist for site initiation visit

cra monitoring visit checklist for site initiation visit Effective Date: the Sponsor's Site Initiation Visit and to outline, using a checklist, the ... a) Agree with the Monitor the scheduled date, time and location of the study initiation visit. b) Ensure that the Investigator/Clinical Research Co-ordinator ... http://www.accreditgcp.com/download/site_sop/en/sop-t1-en.pdf Preparing for a Monitoring Visit Who Attends an Initiation Visit? • Sponsor/CRO: • Clinical Research Associate (CRA)/Monitor. • Medical Monitor. • Project Manager. • Site: • PI/AIs ... http://clinicaltrial.vc.ons.org/file_depot/0-10000000/0-10000/3367/folder/14779/Study_Site_Visits1.pdf INVESTIGATOR STANDARD OPERATING PROCEDURE SOP: T1/7 Effective Date ... b) Ensure that the Investigator/Clinical Research Co-ordinator ... c) Before the meeting complete the checklist contained in ... During the Site Initiation Visit a) Establish the monitoring visit schedule with the Monitor. ... cra monitoring visit checklist for site initiation visit http://www.hku.hk/ctc/download/research/book/sop_t1.pdf ICH CRA Certification Guide – September 2009 site/investigator selection, study initiation activities, study termination activities, .... c) draft ancillary forms (e.g., source documentation checklist) .... f) obtain copy of site monitoring visit log and review for completeness ... http://216.147.199.31/PDF/ICH-CRA-Guide.pdf FDA CRA Certification Guide (North America) – September 2009 site/investigator selection, study initiation activities, study termination activities, .... 3. draft ancillary forms (e.g., source documentation checklist) .... 6. obtain copy of site monitoring visit log and review for completeness ... http://216.147.199.31/PDF/FDA-CRA-Guide.pdf STANDARD OPERATING PROCEDURES FOR GOOD CLINICAL PRACTICE BY ... consent from Thomson Center for Clinical Research Practice. ... Initiation Visit and Site Training. A. Initiation Visit Preparation. B. Investigative Site Training ..... Monitoring Visit Checklist and Report(s) dated ______ ... http://www.ahcpub.com/products_and_services/TOC/SOPSP05_sample.pdf cra monitoring visit checklist for site initiation visit