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