The Human Study Lifecycle
Logistics for your Human Study
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The Office of Investigational New DrugInvestigational New Drug(or IND) an application filed with the FDA that includes a detailed description of the planned investigation including Phase I, II and III studies. ( INDINDInvestigational New Drug application with the FDA. ) and Investigational Device ExemptionInvestigational Device Exemptionapproval by the FDA which allows an unapproved medical device to be shipped for use for research purposes. ( IDEIDEInvestigational Device Exemption filed with the FDA ) applications to the FDAFDAabbreviation for US Food and Drug Administration. . OCR has the ability to decrease investigator burden by electronically submitting to the FDA on the investigator's behalf.(OCR) can assist investigators with preparation and submission of
When a local investigator holds an IND or IDE, they are known as a sponsor-investigatorSponsor-Investigatoris an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug/device is being administered, used or dispensed. For administrative reasons, only one individual should be designated as the sponsor. Usually, the intent of the sponsor-investigator IND/IDE is to gain scientific knowledge without seeking market approval for the drug or device. These are considered 'Investigator-Initiated' or sponsor-investigator IND/IDEs. . Sponsor-Investigators assume the sponsor responsibilities for the study, such as ensuring the study is monitored and regular reporting to the FDA. OCR has investigator services to assist with monitoring activities.
Sponsor-Investigators are required to complete additional training modules and assume additional responsibilities.
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 email@example.com
- -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 Authorization AgreementIRB Authorization Agreementan institutional agreement where an institution agrees to rely on the IRB from the other institution for the review and continuing oversight of its human research. :
- -Collaborative research activities between UTHealthSA and non-UTHealthSA sites
- -Deferral to an external IRBExternal IRBAn IRB operated by an organization other than UTHealthSA
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.
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 ( performance sitePerformance Sitea physical location where research activities or protocol-directed procedures are performed. ).
- -Who will perform the procedures (e.g., study team, clinical providers, service providers, etc.)
- -Whether the procedures are part of standard careStandard Carecare or procedures that are routinely or typically provided absent a research study. (Also called generally accepted practice, routine or conventional care) or research onlyResearch Onlya procedure or activity performed solely for the study.
The CTO provides a Schedule of Activities Template
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.
- -Research 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
The CTO provides budget development and sponsorSponsorare the agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study. negotiations services for all investigators upon request. During the budget development process the CTO will work with the researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 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 clinical servicesClinical Servicesinclude clinical care, clinical tests or clinical procedures that are delivered as part of healthcare (i.e. delivered by professional and technical staff in a clinic, hospital, laboratory, research center, etc.). 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 research 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 ClinCardClinCarda debit card used to pay participants. - 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 research sponsored by a pharmaceutical or deviceDevicean instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the USPÐNF, OR 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. company or other for-profit entity - Learn about university's review fees
- --If an institutionInstitutionany public or private entity or agency (including federal, state or other agencies). other than the university is relying on the UTHSA IRB - Learn about the fees for providing IRB services through an IRB authorization agreement
- --If conducting research funded by a federal grant or contract - Learn more about how to calculate facilities and administrative (F&A) rates from OSP
Research Conflict of Interest
All UTHealthSA faculty and staff who are engaged in researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. are required to disclose possible Conflicts of Interest related to their research through the iDiscloseiDiscloseUT Health San Antonio's application for disclosing outside professional activities including activities that could be Conflicts of Interest. system. 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
Protecting Intellectual Property
ResearchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. often leads to the development of novel ideas, groundbreaking inventions or intellectual propertyIntellectual Propertyincludes but not limited to any invention, discovery, creation, know-how, trade secret, technology, scientific or technological development, research data, works of authorship and computer software regardless of whether subject to protection under patent, trademark, copyright or other laws. . 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 intellectual property is the responsiblitiy of the researcher.
Learn more or obtain assistance from the Office of Technology Commercialization (OTC).