Procedures for overseeing research studies, ensuring adherence to protocols, regulatory requirements, and data integrity. CM001 Site Initation Visits Document CM001 Site Initiation and Sponsor Authorisation v8.0 (911.6 KB / 0) Document CM001-T01 Site Initiation Visit Report v7.0 (169.99 KB / 0) Document CM001-T02 Sponsor's Authorisation to Open v5.0 (161.1 KB / 0) Document CM001-T03 Regulatory Greenlight Checklist v3.0 (156.25 KB / 0) Document CM001-T04 Site Initiation Follow Up Letter v3.0 (152.75 KB / 0) Document CM001-T05 Opening an Additional Centre for a Location v1.0 (163.38 KB / 0) Document CM001-T06 Trial Set Up Process Flow v1.0 (365.15 KB / 0) CM002 Monitoring of Active Studies Document CM002 Monitoring of Active Studies v7.0 (899.21 KB / 0) Document CM002-T01 Monitoring Visit Report v5.0 (189.16 KB / 0) Document CM002-T02 Contact Report v2.0 (154.85 KB / 0) Document CM002-T03 Monitoring Visit Actions Log v4.0 (158.49 KB / 0) Document CM002-T04 Monitoring Visit Log v4.0 (151.51 KB / 0) Document CM002-T05 Performing a Monitoring Visit v3.0 (166.78 KB / 0) Document CM002-T06 Monitoring Visit Follow Up Letter v3.0 (156.56 KB / 0) CM003 Close Out Visits Document CM003 SOP Close Out Visits v8.0 (903.29 KB / 0) Document CM003-T02 Close Out Visit Report v7.0 (169.5 KB / 0) Document CM003-T03 Site Close Out Checklist v4.0 (161.54 KB / 0) Document CM003-T04 Study level close out checklist v4.0 (157.65 KB / 0) Document CM003-T05 Close Out Visit Actions Log v3.0 (153.66 KB / 0) Document CM003-T06 Close Out Follow Up letter v3.0 (152.6 KB / 0) Document CM003-T07 Close Out Process Flow v1.0 (366.07 KB / PDF) Document CM003-T08 Final close out letter template v3.0 (152.89 KB / 0) CM004 Developing a Monitoring and SDV Plan Document CM004 Developing Monitoring and SDV Plans v6.0 (978.73 KB / 0) Document CM004-T01 Monitoring Plan v5.0 (171.67 KB / 0) Document CM004-T02 SDV Plan v5.0 (181.4 KB / 0) This article was published on 2024-11-07
