Page 5 - eBook Version 8 Book 1 of 2 JUL 2022
P. 5
eBook Manual of Operations
Book 1 of 2
Study Coordination
VOLUME 1 | REGULATORY & FINANCE
SECTION 1: Study Start-Up
R-Reg-001 Overview of Study Start-Up R-Reg-002 Study Assignments & Productivity R-Reg-003 Lab Initiation & Feasibility
R-Reg-004 Investigational Drug Services Initiation R-Reg-005 Securing Reimbursement
R-Reg-006 eResearch Guidance
R-Reg-007 Performance Site Approval
R-Reg-008 Data Dictionary
R-Reg-009 ClinCard: Subject Stipends
SECTION 2: Study Maintenance
R-Reg-100 Regulatory Binder
R-Reg-101 Clinical Research Essential Resource
R-Reg-102 Regulatory & Finance Modifications
R-Reg-103 Creating Study Logs
R-Reg-104 Internal Quality Reviews
R-Reg-105 Continuing Reviews
R-Reg-106 Reportable Events
R-Reg-107 Preparing Lab kits
R-Reg-108 EPIC Research Billing Review
R-Reg-109 Ordering Labs
R-Reg-110 Investigational Drug Orders
R-Reg-111 Managing Investigational Devices & Medical Equipment
SECTION 3: Study Close-Out
