Need Help?
OIRB: IRB@uthscsa.edu; 210-567-8250
Logistics for your Human Study
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FDA Submissions
The Office of (OCR) can assist investigators with preparation and submission of Investigational New ( ) and Investigational Exemption ( ) applications to the . OCR has the ability to decrease investigator burden by electronically submitting to the FDA on the investigator's behalf.
When a local investigator holds an or , they are known as a -investigator. -Investigators assume the sponsor responsibilities for the study, such as ensuring the study is monitored and regular reporting to the . OCR has investigator services to assist with monitoring activities.
Guidance on IND/IDE Submissions
Contact the OCR for assistance: IRBreliance@uthscsa.edu; 210-567-8555
Sponsor-Investigators are required to complete additional training modules and assume additional responsibilities.
Learn more about required training modules.
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Agreements with Sponsors / Non-UTHSA Collaborators
Collaborating with another organization or outside entity often requires a written agreement.
The following agreements must be reviewed and approved by the Office of Sponsored Programs. Forward all agreements to OSP at contracts@uthscsa.edu
- Clinical Trial Agreements (CTA)
- Confidential Disclosure Agreements (CDA)
- Consulting Agreements (CA)
- Lab Testing Agreements (LTA)
- Material Transfer Agreements (MTA)
- Research Agreements (RA)
- Data Use Agreement (contact OSP for current template)
- Business Associate Agreement (contact OSP for current template)
The following require an IRB Agreement :
- Collaborative activities between UTHealthSA and non-UTHealthSA sites
- Deferral to an
UTHealthSA participates in the SMART IRB Agreement allowing collaboration with over 800 institutions/external IRBs.
Learn more about participating institutions signed on to the SMART IRB Agreement.
If your collaborating or is not part of SMART IRB, contact the UTHealthSA IRB.
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Study Schedule of Activities
A comprehensive schedule of activities is needed to plan study logistics. The schedule should contain:
- Study procedures, how often and when
- Locations where procedures will be performed ( ).
- Who will perform the procedures (e.g., study team, clinical providers, service providers, etc.)
- Whether the procedures are part of or only
The CTO provides a Schedule of Activities Template
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Managing Your Data
Information System (IS) in the Department of Population Health Sciences (PHS) provides a full spectrum of analytical, programming, database, administration, project management, and security experience and skills to build, deliver, support, and maintain sophisticated data management capabilities.
- Data Managment Systems - IDEAS and REDCap
- Data Managment Consulting
- Project and Security Consulting
- Learning Management and Content Development - Moodle
- Data Management
Learn more about the Information Systems Services
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Budget Development
The CTO provides budget development and negotiations services for all investigators upon request. During the budget development process the CTO will work with the team to identify the direct costs for the project.
- Items to Consider When Developing Your Budget:
- Personnel Expenses - Salary for investigators & study staff
- Study Procedures, Equipment, and Supplies
Clinical Service Fees - Depending on the nature of the study, agreements with clinical service providers (e.g., Radiology, Laboratory) may be needed.
-- Radiology can be requested using the on-line form.
-- Please note that the CTO will negotiate an agreement and pricing with each UT clinical department using the fee schedule (charge master) on behalf of the PI.
- -Participant Payment - download and use the Inst-B form to develop the payment schedule. For more information regarding participant payments use the CTO Process Guide
--If using - include the ClinCare user fees in your budget as follows: $4/card (one card per subject) and $2/payment transaction (each time you pay a participant = one transaction).
-Marketing and Advertising costs
--If conducting sponsored by a pharmaceutical or company or other for-profit entity - Learn about university's review fees
- --If an other than the university is relying on the UTHSA IRB - Learn about the fees for providing IRB services through an IRB agreement
- --If conducting funded by a federal grant or contract - Learn more about how to calculate facilities and administrative (F&A) rates from OSP
- Items to Consider When Developing Your Budget:
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Research Conflict of Interest
All UTHealthSA faculty and staff who are are required to disclose possible Conflicts of Interest related to their through . Conflicts for all study personnel are also disclosed in the research application when submitted for IRB review.
For questions about Conflicts of Interest, contact the COI Manager at COI@uthscsa.edu
Learn more about Conflict of Interest or submit a disclosure in ERMS-COI.
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Protecting Intellectual Property
often leads to the development of novel ideas, groundbreaking inventions or . It is important to protect your ideas before you publically disclose the details of one's intellectual property during a technical presentation in a public forum (seminar, conference, symposium, Grand Rounds). Contact the Office of Technology Commercialization as soon as possible.
Secure storage of the original data and observations related to is the responsiblitiy of the researcher.
Learn more or obtain assistance from the Office of Technology Commercialization (OTC).