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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
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Pre-Screen
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Principal-Investigator
Prisoner
Privacy
Private-Information
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Protocol
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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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Quality Assurance

activities particular to an institution's QA program, such as those activities protected from disclosure by the Department of Veterans Affairs as part of its confidential medical quality-assurance program or other equivalent programs. (e.g., see VHA Directives or equivalent university or institutional policy)

See also: Non-Regulated Research
Quality Improvement

systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of health care in particular settings. QI involves deliberate actions to improve care, guided by data reflecting the effects QI is generally not considered research Ð however, QI activities can be research if they are also intended to contribute to generalizable knowledge.

See also: Non-Regulated Research
Quorum

the minimal number of IRB or IACUC members who must be present at a convened meeting for valid transaction of business.

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