Human Subject Standard Operating Procedures (SOPs)

Research Service - Administration  •  Quality Assurance
Informed Consent  •  Training & Education  •  
Pharmacy  •  Devices & Procedures  •  Investigator Study Conduct

Please note that forms listed below are to be printed and manually completed.

RESEARCH SERVICE - ADMINISTRATION
SOP Number	Title	Appendixes/ Attachments
01.01	The Human Research Protection Program	None
01.02	VAMHCS Human Research Protection Plan (HRPP)	Organizational structure of responsibilities for the VAMHCS HRPP Process flowchart for the implementation of the VAMHCS HRPP FWA – VAMHCS FWA – BREF FWA – UMB MOU – VAMHCS-UMB
01.03	R&D Committee	Worksheet for Submissions to R&D Committee (Human Studies) Flowchart Guidance on R&D Submissions Research Methods Accountability Form (RMAF) - DISCONTINUED Clinical Trials Data Sheet - DISCONTINUED Outpatient Clinic Profile VA Form 10-9012 VA Pharmacy Use Initiation Forms and Memorandum VA R&D Committee Evaluation Tool
01.05	Flowchart Guidance on R&D Submissions (not available online)	None
01.06	Establishment of the Human Research Protection Program Committee	None
01.07	Guidelines for Addressing and Responding to Research-Related Complaints and Allegations of Noncompliance with Institutional Policies Related to the Human Research Protection Program	Complaint Information Form
01.08	Addressing and Responding to Allegations of Noncompliance with Institutional Policies Related to the Human Research Protection Program	None
01.09	Conducting Human Participants Research at the VAMHCS: The Relationship of VAMHCS Research Standard Operating Procedures to the Policies and Procedures of the UMB Human Research Protections Office (HRPO)	None
01.12	Review of Research Documentation for Compliance with Privacy Requirements	None
01.13	Information Security Review of Research Protocols	None
01.14	Negotiating and Entering into Phase I, II, III and IV Clinical Trial Agreements (CTA) with Sponsors	None
01.15	Negotiating and Entering into Phase I, II, III and IV Clinical Trial Cooperative Research & Development Agreements (CRADA)	None

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QUALITY ASSURANCE
SOP Number	Title	Appendixes/ Attachments
02.01	Overview of Quality Assurance Activities	Self-Assessment Tool: Subject Records Checklist Self-Assessment Tool: Investigator Records Checklist Self-Assessment Tool: Investigator/Staff Interview Checklist Self-Assessment Tool: Informed Consent Form Review Checklist Documents Typically Subject to Audit
02.02	Audit Triggers	Sample Audit Notification Letter Determination of Audit Sample Documents Typically Subject to Audit Problem Resolution Worksheet Table of Contents of Research Service SOPs
02.03	Auditing Source Document Charts	Sample Audit Notification Letter Determination of Audit Sample Documents Typically Subject to Audit Internal Source Documents Audit Internal Source Documents Guidelines Problem Resolution Worksheet Chart Audit Log
02.04	Investigator Responsibilities for Internal Quality Assurance of Their Research Programs	None
02.05	Auditing the Investigational Pharmacy	Study Subject Worksheet Pharmacy Audit Form A: Investigational Drug Dispensing Tool Companion Tool for Pharmacy Form A Pharmacy Audit Form B: Investigational Drug Log Tool Companion Tool for Pharmacy Form B Pharmacy Audit Form C: Investigational Pharmacy Audit Report VAMHCS Investigational Pharmacy Drug Log

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INFORMED CONSENT
SOP Number	Title	Appendixes/ Attachments
03.01G	Informed Consent Guidebook	Essential and Additional Elements of Informed Consent Lay Language for Informed Consent Sample VA Form 10-1086 Tests of Understanding and Decisional Capacity Self-Assessment Tool: Informed Consent Form Review Checklist
03.02	Writing a VAMHCS Informed Consent Form	Sample VA Form 10-1086 Elements of Informed Consent
03.03	Obtaining & Documenting Informed Consent	None

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TRAINING & EDUCATION
SOP Number	Title	Appendixes/ Attachments
04.01	Stand Down SOP	Multiple, expired
04.02	Research Personnel - Mandatory Training	None
04.03	Research Personnel – Conditions for Employment or Without Compensation (WOC) Appointment	None

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PHARMACY
SOP Number	Title	Appendixes/ Attachments
05.01	Research & Investigational Drugs	Clinical Trials Data Sheet - DISCONTINUED Research Methods Accountability Form (RMAF) - DISCONTINUED VA Form 10-9012 Pharmacy Fee Form Study Drug Dispensing Log

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DEVICES & PROCEDURES
SOP Number	Title	Appendixes/ Attachments
06.01	Control and Use of Devices, Equipment and Procedures in the Conduct of a Research Study	Attestation for the Use of Devices, Equipment& Procedures… Sample credentialing/training log Sample accountability log

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INVESTIGATOR STUDY CONDUCT
SOP Number	Title	Appendixes/ Attachments
07.01	Enrollment Notes for Research Participants	Enrollment Note Algorithm Enrollment Note Form Clinical Warning Algorithm Clinical Warning Form Sample of an Enrollment Note Sample of an enrollment Note with Scanned Consent Addendum Cover Letter – Scanned Consent Process Request for Corrections – Scanned Consent Process Sample Clinical Warning
07.02G	Guidelines for Setting up a Study Binder and Regulatory Documents Binder	Clinical trials standards that may be applied during audit proceedings Guidelines for Time-Event Sheets Examples of Time-Event Sheets
07.03G	Guidance on Source Documents	Informed Consent Process Worksheet CRF-DCF Template Guidelines for Time-Event Sheets Examples of Time-Event Sheets Guidelines for Narrative Notes
[07.04G]	Regulatory Documents	Not available at this time
07.05G	Writing Standard Operating Procedures	Template of SOP format
07.06G	Study Specific SOPs	Coordinator’s Checklist for SSSOPs Assignment of Responsibilities (PI) Assignment of Responsibilities (Staff) Sample Time-Event Sheet and Guidelines
07.07G	Accepting a Protocol	List of Services
	Laboratory Processing	Not available at this time

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