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Amendments and Modifications

Changes to:	Who to Contact	Submission Process	Form
Performance Site	OCR	OCR modification process	Modification Form
Service Provider	CTO	VPRCTO@uthscsa.edu
Funding Source	OCR	OCR modification process	Modification Form
Sponsor Budget / Payments	CTO	VPRCTO@uthscsa.edu
Contract or Agreement	OSP	contracts@uthscsa.edu
Study Plan (Recruitment, Drug/Device, Vulnerable Populations, Procedures, Safety Monitoring Plan)	IRB of Record (follow applicable IRB process for external IRB approved protocols)	IRB amendment process (for UTHSA IRB approved protocols)	Amendment Form (for UTHSA IRB approved protocols)
Participant Payment	CTO	VPRCTO@uthscsa.edu
Test Article Storage	OCR	OCR modification process	Modification Form
Data Acquisition, Use, Release, Disposal (UTHSA IRB protocol)	IRB	IRB amendment process	Amendment Form
Data Acquisition, Use, Release, Disposal (External IRB protocol)	IRB of Record & OCR (follow applicable IRB process for external IRB approved protocols)	OCR modification process	Modification Form
Sponsor Investigator Monitoring Plan	OCR	OCR modification process	Modification Form
Coverage Analysis	CTO	VPRCTO@uthscsa.edu
Informed Consent / HIPAA (UTHSA IRB protocol)	IRB	IRB amendment process	Amendment Form
Informed Consent / HIPAA (External IRB protocol)	IRB of Record & OCR (follow applicable IRB process for external IRB approved protocols)	OCR modification process	Modification Form
Depts./Committees/Agencies with Purview over Research (UTHSA IRB protocol)	IRB	IRB amendment process	Amendment Form
Depts./Committees/Agencies with Purview over Research (External IRB protocol)	OCR	OCR modification process	Modification Form
Change to Velos eResearch	CTO		CTMS Change Request form to CTMS-Support@uthscsa.edu
Can't find a scenario that fits your situation?	You can never go wrong contacting OCR!	OCRmail@uthscsa.edu or 567-8555