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Accrual
Acknowledged
Active-Observations
Active-Treatment
Administrative-Change
Adulteration
Adverse-Event
Affiliated-Institution
Agent
Agent-of-the-Institution
Allegation-of-Noncompliance
Amendment
APHIS
Applicable-Clinical-Trial
Appreciation-Payment
Appropriate-Institutional-Official
Assent
Assurance-of-Compliance
Assured-Institution
Attend
Authorization
Authorized-Institutional-Official
Authorized-Representatives
Autonomy
Belmont-Report
Benefit
Benign-Behavioral-Intervention
Billing-Risk
Biological
Biopsy
Body-Cavity
Bonus-Payment
Breeding-Protocol
Capacity
Case-Report-Form
CDA
Certificate-of-Confidentiality
Children
Class-Project
Classified-Research
ClinCard
Clinical-Equipoise
Clinical-Investigation
Clinical-Purpose
Clinical-Research
Clinical-Services
Clinical-Trial
Clinical-Use
Co-Principal-Investigator
Code-of-Federal-Regulations
Coded
Coercion
Cognitively-Impaired
Collaborating-Individual-Investigator
Collector
Community-Based-Participatory-Research
Compassionate-Use
Compensation
Compensation-for-Services-Rendered
Competence
Competitive-Enrollment
Completed
Confidential-Disclosure-Agreement
Confidentiality
Conflict-of-Commitment
Conflict-of-Interest
Consent
Consent-Signed
Consultant
Continuing-Noncompliance
Continuing-Review-of-Research
Conventional-Care
Cooperative-Research
Covered-Entity
CTA
Custom-Device
Customer-Satisfaction-Survey
Data-Management-Center
Death-As-An-Endpoint
Debriefing
Deception
Declaration-of-Helsinki
Deficiency
Department-Managed-Procedure-Room
Designated-Reviewer
Deviation/IACUC
Deviation/IRB
Device
DHHS
Did-Not-Consent
Dietary-Supplement
Dissent
DLAR-Managed-Areas
Drug
Drug-Claim
Electronic-Medical-Record
Embryo
Emergency-Use
Emergency-Violation
Employee
Engaged-in-Research
Enrolled
Enrollment
EpicCare-Link
Equitable
eResearch
Euthanasia
Ex-Officio
Exception
Exempt-Human-Subjects-Research
Existing-Data
Existing-Specimen
Expanded-Access
Expedited-Review
Experimental
Experimental-Endpoints
Expired-Medical-Materials
Exploitation
External-IRB
External-UPIRSO
Fabrication
Falsification
FDA
FDA-Approved
FDA-Regulated-Research
Federal-Wide-Assurance
Fetus
Financial-Records
Financial-Sponsor
Finder's-Fee
Finding-of-Noncompliance
Follow-up-as-Planned
Freund's-Adjuvant
Generalizable-Knowledge
Guardian
Halt
Handicapped
Health-Information
Health-Science-Center
Health-Surveillance
HHS
Housing-Room
HUD-Clinical-Investigation
Human-Subject
Human-Subjects-Research
Humane-Endpoints
Humanitarian-Device-Exemption
Humanitarian-Use-Device
IACUC-of-Record
IDE
Identifiable
Identifiable-Biospecimen
Identifiable-Private-Information
Identifiable-Sensitive-Information
Identified
iDisclose
Immediately-Life-Threatening-Disease
Impaired-Decision-Making-Ability
In-Vitro
In-Vivo
Incapacitated
Incompetent
Incomplete-Disclosure
IND
Individual-Investigator-Agreement
Individually-Identifiable-Health-Information
Individually-Identifiable-Private-Information
Inducements
Informed-Consent
Initial-Review-of-Research
Innovative-Therapy
Institution
Institutional-Organized-Research-Unit
Institutional-Review-Board
Institutionalized
Intellectual-Property
Interaction
Internal-UPIRSO
Intervention
Intervention-Stopped-Early---Follow-up-Complete
Intervention-Stopped-Early---Following
Interventional-Study
Interventional-Study-Purpose
Invasive
Investigational-Device-Exemption
Investigational-Devices
Investigational-Drug
Investigational-New-Drug
Investigator-Initiated
IRB-Authorization-Agreement
IRB-of-Record
Key-Personnel
Legally-Authorized-Representative
Legally-Effective-Informed-Consent
Life-threatening
Limited-IRB-Review
Major-Change-or-Modification
Major-Survival-Surgery
Mature-Minor
Medical-Device
Mentally-Disabled
Minimal-Risk
Minimizing-Risk
Minor-Change-or-Modification
Minor-Survival-Surgery
Morbund-Condition
Multicenter-Research
Multisite-Research
Neonate
New-Drug-Application
Non-Assured-Institutions
Non-Exempt-Human-Subjects-Research
Non-Human-Research
Non-Interventional-Research
Non-Pharmaceutical-Grade-Compound
Non-Pharmacologic-Measures
Non-Regulated-Research
Non-Surgical-Procedure
Non-Survival-Surgery
Non-Therapeutic-Research
Noncompliance
Nonsignificant-Risk-Device
Nonviable-Neonates
Observational-Study
Observational-Study-Model
Observational-Study-Time-Perspective
Off-Site-Research
Office-of-Human-Research-Protections
Office-of-Laboratory-Animal-Welfare
OIACP
OIRB
Onsite-Monitoring
ORCA
ORU
Parental-Permission
Performance-Site
Pharmaceutical-Grade-Compound
Plagiarism
Pre-Screen
Pre-Screen-Failure
Pregnancy
Principal-Investigator
Prisoner
Privacy
Private-Information
Procedure-Room
Procedures-That-Are-Expected-To-or-May-Cause-More-Than-Momentary-Pain-or-Distress
Program-Evaluation
Prompt-Report
Protected-Health-Information
Protocol
Protocol-Directed
Publicly-Available-Data/Specimens
Quality-Assurance
Quality-Improvement
Quorum
Re-Screening
Recorded
Recruitment
Reduction
Referred
Refinement
Regulatory-Binder
Regulatory-Sponsor
Reimbursement
Related-Adverse-Event
Relying-Institution
Remote-Monitoring
Replacement
Repository
Research
Research-Misconduct
Research-Only
Restraint
Retrospective-Research
Reviewing-IRB
Risk
Run-In/Wash-Out
Screen-Failure
Screened-Participant
Screening
Serious-Adverse-Event
Serious-Noncompliance
Service-Provider
Severely-Debilitating
Significant-Deficiency
Significant-Risk-Device
sIRB
Site-Evaluation-Visit
Site-Initiation-Visit
Source-Document
Specialized-Skill
Sponsor
Sponsor-Monitoring
Sponsor-Investigator
Sponsor-Investigator-IND/IDE
Standard-Care
Standard-Practice
Study-Operations-Center
Sub-Investigator
Subject-Statuses
Substantial-Impairment
Substantive-Changes
Substantive-Clarification
Surgery
Surrogate-Consent
Survival-Surgery
Suspension-of-Research
Systematic-Investigation
Terminal-Procedure
Termination-of-Research
Test-Article
Therapeutic-Research
Treatment-Team
Treatment-Use-of-a-Humanitarian-Device
Unanticipated-Adverse-Device-Effect
Unanticipated-Problem-Involving-Risk-to-Subjects-or-Others
Unapproved-Device
Undue-Influence
Unexpected-Adverse-Event
Unidentifiable
USDA
USDA-Covered-Species
UT-Health-Physicians
VA-Research
Viable
Violation
Voluntary
Withdrawn

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Electronic Medical Record

(EMR) - digital version of a medical chart that contains all of a patient’s medical history from one provider or facility.

Embryo

early stages of a developing organism, broadly used to refer to stages immediately following fertilization of an egg through implantation and very early pregnancy (i.e., from conception to the eighth week of pregnancy).

Emergency Use

when an unapproved drug or device is used to treat a patient in an emergency situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval. Emergency means life-threatening (drug & device), severely debilitating (drug), or serious disease or condition that needs immediate treatment (device).

Emergency Violation

a departure from the approved protocol without prior IRB approval that occurs in an emergency situation, such as when a departure from the protocol is required to eliminate apparent immediate hazard to the subject.

Employee

is a person who is hired for a wage, salary, fee or payment to perform work for an employer. Employees are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.

See also: Agent of the Institution
Engaged in Research

in general, an institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; (3) the informed consent of human subjects for the research; 4) whenever the institution receives a direct HHS award to support such research, even if all of the human subjects activities will be performed by agents or employees of another institution.

Enrolled

screened participants are enrolled if eligibility is verified (meet all inclusion criteria and none of the exclusion) and they consent to continue in the study.

Enrollment

the process of seeking eligible participants and obtaining their consent to participate in the research. Enrollment generally starts with recruitment, leading to screening for eligibility, and consent to enroll in the study.

EpicCare Link

The Epic web-based EMR portal that allows secure access to select patient information for designated users.

Equitable

fair or just; used in the context of selection of subjects, to indicate that the benefits and burdens of research are fairly distributed.

eResearch

Velos eResearch is UT Health San Antonio's designated Clinical Trial Management System (CTMS). Velos eResearch is a web-based application designed to centralize the management tasks needed to conduct a clinical trial including study statuses, subject enrollment and activity, study calendars, budgets and billing.

Euthanasia

The humane destruction of an animal accomplished by a method that produces rapid unconsciousness and subsequent death without evidence of pain or distress, or a method that utilizes anesthesia produced by an agent that causes painless loss of consciousness and subsequent death (AWR).

Ex-Officio

a member by virtue of the office held by the individual.

Exception

a one-time, intentional action that departs from the IRB approved protocol for a single subject. An exception is identified before it occurs and is under the control of the investigator.

Examples include (but are not limited to): enrollment of a single subject who does not meet all eligibility criteria for a study, but the investigator and sponsor have agreed this subject should be enrolled. 

Exempt Human Subjects Research

research that meets the regulatory definition of human subjects research and qualifies for exemption.

Existing Data

data in the records or on the shelf prior to IRB review and was created for a reason other than the proposed research. All data included in the request to analyze existing data must exist at the time the research is proposed.

Existing Specimen

specimen on the shelf prior to IRB review and was created for a reason other than the proposed research. All speciments included in the request to analyze existing specimens must exist at the time the research is proposed.

Expanded Access

use of an investigational (unapproved) drug or device when the primary purpose is to diagnose, monitor, or treat a patient's disease or condition. The distinction between expanded access and the use of an investigational drug (or device) in research covered under an IND/IDE is that expanded access uses are not primarily intended to obtain information about the safety or effectiveness of a test article. Although not considered research, the FDA requires IRB approval prior to non-emergency use.

See also: Compassionate Use
Expedited Review

review process when one or more a designated IRB member review a business item instead of at a convened meeting of the board.

Experimental

term often used to denote an intervention (e.g., drug, device, procedure.) that is unproven or scientifically yet to be validated with respect to safety and efficacy. Often used to denote FDA approval has not yet been obtained. A procedure may be considered experimental without necessarily being part of a formal study (research) to evaluate its usefulness.

Experimental Endpoints

The scientific aims and objectives of the study. Experimental endpoints are used to determine when animals have completed the study, and can be transferred or euthanized.

Expired Medical Materials

Materials such as drugs, fluids, or sutures that have exceeded the to be used by date or expiration date.

Exploitation

when one has unfair advantage over another. Often raised as a concern when paying (offering inducements to) vulnerable populations (e.g., economically disadvantaged or institutionalized individuals). Paying economically disadvantaged individuals the same amount as would be paid to others who are not disadvantaged may be seen as unduly influential. However, paying these individuals less to reduce undue influence may be seen as exploitative.

External IRB

An IRB operated by an organization other than UTHealthSA

See also: Reviewing IRB
External UPIRSO

adverse events and unanticipated problems experienced by subjects enrolled by investigator(s) at an institution not affiliated with UTHSCSA.

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UT Health San Antonio

8403 Floyd Curl Dr
San Antonio, TX 78229

210-567-8270
vpr@uthscsa.edu

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