Page 148 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
• Standard Review
• Credentialing of Study Team
• Study Budget & Contracts Initiation
• Coverage Analysis (CTCA)
• Clinical Trial Agreement (CTA)
• Service Order Agreement (SOA)
• Service Order Worksheet (SOW)
Research Administration SOP No: A017 SOP Title: Virtual Office Navigator
• Regulatory
o Velos (Study Registration, eIRB Initiation, EPIC Integration) o IRB Approval
o Performance Site Approval (PSA)
o *Site Initiation Visit (SIV)
4.3 Pre-Study Initiation Processes
The study initiation process is demarcated by a series of ordered milestones. It is essential that the laws and regulations are followed as a base practice. Such governing mandates preside over and are observed in the institution’s policies and integrated standard operating procedures toward the establishment and reinforcement of best practices (see SOPs Titled Overview of Study Start-Up; and Securing Reimbursement for Your Study). Further, it is crucial to the sustainability of our mission that all research related services incurred at CHST are accounted for in a study budget and can be reimbursed via study finance management (see SOPs Titled Managing EPIC Billing Compliance) in compliance with the aforementioned No SOA/ No Work Rule.
Conduct Site Feasibility Assessment & Visit (*SEV)
Complete Pre-Study Start-Up Activities
Initiate Study Budget & Contract (CTA and CTCA)
Obtain Study Budget & Contracts Approvals
Obtain Regulatory Approval (IRB and PSA)
Complete Essential Documents and Regualtory Binder
Conduct the Site Initiation Visit (*SIV)
4.4 Study Maintenance
Most central to our mission Toward the Relentless Discovery of the Treatments of Tomorrow is the actual conduct of our research protocol in the acquisition of data that helps build the scientific body of knowledge to advance medical practice. Study maintenance involves a specialized set of skills and knowledge in order to provide quality and ethical treatment of our subjects and data. This phase of study life cycle requires mindful coordination of routine, concentric functions to ensure safety and integrity in the progress of the research. For more information on the nuances of carrying out each of the study maintenance objectives below, please reference the Research Administration eBook and Guide to Research Administration.