United States Department of Veterans Affairs

Ralph H. Johnson VA Medical Center

For Investigators: QA Manual

 The QA Manual sets forth the Basic criteria to ensure compliance with regulations and policies. Standard Operating Procedures (SOP) document the implementation of Quality System.

 

QA Manual: Table of Contents
SOP 01: Control of Quality System Documentation
SOP 02: Internal Audits
SOP 03: Quality System Reviews
SOP 04: Corrective Action Plan to Audit Findings
SOP 05: Approval and Operations for Clinical Studies
SOP 06: Performance of Clinical Studies
SOP 07: Informed Consent
SOP 08: Pre-Study Requirements
SOP 09: Investigator Agreements with Sponsors
SOP 10: Clinical Research Coordinator Selection
SOP 11: Adverse Event Report Procedures
SOP 12: Data Management
SOP 13: Regulatory Documentation
SOP 14: Study Close Out Procedures
SOP 15: PI's Responsibilities and Qualifications
SOP 16: Misconduct of Scientific Research
SOP 17:  Research and Development Committee (VA Studies Only)
SOP 18: Subcommittee on Research Safety (VA Studies Only)
SOP 19: IACUC (VA Studies Only)
SOP 20: Research Involving Investigational Devices
SOP 21: Reporting of Adverse Events in Research to the Office of Research Oversight
SOP 22: Management of Research Data
SOP 23: Use of Computerized Records for Research Recruitment
SOP 24: Information and Data Protection
SOP 25: Scanning Informed Consent Documents and HIPAA Authorization into CPRS
SOP 26:  Without Compensation (WOC)
Appedix A: Investigator Self Audit
Appedix B: Regulatory Binder Template
Appedix C: Research Service Organizational Chart
GCPG: Good Clinical Practice Consolidated Guidelines
HRPP:  Human Research Protection Program
MOU: IRB Memorandum of Understanding
MOU-c-IRB:  VA Central IRB Memorandum of Understanding
QI vs Research:  How to Determine if Activity is Quality Improvement or Research

M. Rita I. Young, Ph.D.
Associate Chief of Staff for Research

E-mail:  rita.young@va.gov
Phone: (843) 789-6707;  Fax: (843) 876-5384
Research Service
Ralph H. Johnson VA Medical Center
109 Bee Street
Charleston, SC  29401

 



Useful Research Links

Charleston VA Research Home 

 

Our Research Program 

 

For Investigators 

 

Charleston Research Institute 

 

For Veterans Interested in Participating in Research