Trial Title: Trigger for Monitoring Visit Visit trigger: Date of previous visit: Visit Information Date of visit: Site name: Site address: PI: Site personnel <include role> present: Monitor(s): <include role> <specify which patients were reviewed for Consent & Eligibility, Trial patients and SAEs, SDV, etc. If appropriate, also indicate the CRFs CRFs reviewed: reviewed.> Version of Monitoring Plan used at visit: Report Information Date report sent: Site personnel report sent to: Deadline for response: Report Sections General Comments/Major Findings Summary of Monitoring Performed At Site Attachments Signatures Appendices Appendix 1 On-site Monitoring Visit Report Actions (CAPA) Research Team – – <List actions in Appendix 1 for research team> General Comments/Major Findings The monitor would like to thank staff for their help and hospitality during the visit. <add additional comments or major findings> Summary of Monitoring Performed At Site
Trial Title: Trigger for Monitoring Visit Visit trigger: Date of previous visit: Visit Information Date of visit: Site name: Site address: PI: Site personnel present: <include role> Monitor(s): <include role> Trial patients and CRFs reviewed: <specify which patients were reviewed for Consent & Eligibility, SAEs, SDV, etc. If appropriate, also indicate the CRFs reviewed.> Version of Monitoring Plan used at visit: Report Information Date report sent: Site personnel report sent to: Deadline for response: Report Sections General Comments/Major Findings Summary of Monitoring Performed At Site Attachments Signatures Appendices Appendix 1 – On-site Monitoring Visit Report Actions (CAPA) – Research Team <List actions in Appendix 1 for research team> General Comments/Major Findings The monitor would like to thank staff for their help and hospitality during the visit. <add additional comments or major findings> Summary of Monitoring Performed At Site
PRISM%20Monitoring%20Visit%20-%20Report%20v1.0%2020-06-2016.docx