Welcome to the SOM Clinical Research Glossary
Quickly look up the meaning of words, acronyms, or abbreviations commonly used in clinical research:
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- Adverse Drug Reaction (ADR)
- Adverse Event (AE)
- Adverse Reaction (AR)
- Age of majority
- AIR (Activities Interests and Relationships)
- ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate)
- ALCOA Plus, ALCOA+
- ALICE
- Ancillary review
- Applicable Clinical Trial (ACT)
- Applicable regulatory requirements
- Approved drug
- Arm
- Aspirational benefit
- Assent
- Assessment
- Association for Clinical and Translational Science (ACTS)
- Association for the Accreditation of Human Research Protection Programs (AAHRPP)
- Association of Clinical Research Professionals (ACRP)
- Attrition
- Audit
- Audit report
- Audit trail
- Award
- Baseline
- Baseline assessment
- Benefit
- Bias
- Billing Coverage Analysis (BCA)
- Biobank
- Biologic
- Biological Product
- Biological specimen
- Biologics License Application (BLA)
- Biomedical Research Imaging Center (BRIC)
- Biospecimen
- Biospecimen Processing Facility (BSP)
- Blinding
- BLUE
- Breach of confidentiality
- Budget
- Budget justification
- Budget period
- Budget revision
- Business Associate
- Business Associate Agreement (BAA)
- Carolina Data Warehouse for Health (CDW-H)
- Case Report Form (CRF)
- Causality
- Cayuse
- Ceded review
- Centers for Disease Control and Prevention (CDC)
- Centers for Medicare & Medicaid Services (CMS)
- Centralized monitoring
- Certificate of Confidentiality (CoC)
- Certified copy
- Child
- Clinical and Translational Science Awards (CTSA) Program
- Clinical development
- Clinical investigation
- Clinical monitor
- Clinical research
- Clinical Research Accountability Unit (CRAU)
- Clinical Research Associate (CRA)
- Clinical Research Coordinator (CRC)
- Clinical Research Management System (CRMS)
- Clinical Research Support Office (CRSO)
- Clinical significance
- Clinical study
- Clinical trial
- Clinical Trial Agreement (CTA)
- ClinicalTrials.gov
- Clinical Trials Quality Assurance (CTQA) Program
- Coded
- Code of Federal Regulations (CFR)
- Cohort
- Co-investigator
- Collaborative Institutional Training Initiative (CITI)
- Collateral benefit
- Commercial Institutional Review Board (IRB)
- Common data model
- Common Rule
- Common Terminology Criteria for Adverse Events (CTCAE)
- Compensation
- Competitive Renewal
- Complaint
- Compliance
- Computable Phenotype
- Concomitant medication
- Confidential Disclosure Agreement (CDA)
- Confidentiality
- Conflict of Interest (COI)
- Conflict of Interest Office
- Consent capacity
- Continuing noncompliance
- Continuing review
- Contract
- Contract Research Organization (CRO)
- Control group
- Coordinating Center (CC)
- Corrective and Preventive Action (CAPA) Plan
- Data
- Data acquisition
- Data and Safety Monitoring Board (DSMB)
- Data and Safety Monitoring Committee (DSMC)
- Data and Safety Monitoring Plan (DSMP)
- Database
- Database Management System (DBMS)
- Data encryption
- Data entry
- Data Integrity
- Data Management and Sharing Plan (DMS Plan)
- Data Management Plan (DMP)
- Data Management System (DMS)
- Data Monitoring Committee (DMC)
- Data Use Agreement (DUA)
- Deferral
- Delegation of Authority (DOA) Log
- Demographic data
- Department of Health and Human Services (DHHS)
- Direct benefit
- Direct cost
- Disapproval
- Discontinue
- Disease registry
- Dosage regimen
- Dose Limiting Toxicity (DLT)
- Double blinding
- Drug
- Drug toxicity
- ECRT (Effort Certification and Reporting Technology)
- Efficacy
- Effort
- Electronic Case Report Form (eCRF)
- Electronic Data Capture (EDC)
- Electronic Health Record (EHR)
- Electronic Informed Consent (eIC)
- Electronic Medical Record (EMR)
- Elements of informed consent
- Embryonic Stem Cell Research Oversight (ESCRO) Committee
- Encounter
- Encounter Level Data
- Encryption
- Endpoint
- Engaged
- Enrolled
- Enrollment
- Environment, Health and Safety (EHS)
- Epic
- Essential document
- Exclusion criteria
- Exculpatory language
- Exempt review
- Expanded access
- Expedited review
- Experimental drug
- Experimental group
- Export Compliance Office
- Export control
- Fabrication
- Falsification
- Family Educational Rights and Privacy Act (FERPA)
- FDA Form 482
- FDA Form 483
- FDA Form 1571
- FDA Form 1572
- Feasibility assessment
- Federalwide Assurance (FWA)
- Food and Drug Administration (FDA)
- Food, Drug and Cosmetics Act
- Free text data
- Full board review
- Funder
- Generalizability, Generalization
- Good Clinical Practice (GCP)
- Grant application
- Grant Number
- Guardian
- GxP
- Health literacy
- Healthy volunteer
- HIPAA authorization
- HIPAA covered entity
- HIPAA (Health Insurance Portability and Accountability Act)
- HIPAA Privacy Rule
- Humanitarian Device Exemption (HDE)
- Humanitarian Use Device (HUD)
- Human Research Protection Program (HRPP)
- Human subject
- Human Subjects Research (HSR)
- Hypothesis
- Identifiable biospecimen
- Identifiable private information
- Identifier
- Impartial witness
- Inclusion criteria
- Inclusion/Exclusion (I/E) criteria
- Independent Ethics Committee (IEC)
- Independent IRB
- Indication
- Indirect benefit
- Indirect Facility & Administrative (F&A) costs
- Individual Conflict of Interest (COI)
- Industry
- Industry Contracting (IC)
- Industry sponsored study
- Informed Consent Form (ICF)
- Informed Consent (IC)
- Inspection
- Institution
- Institutional Biosafety Committee (IBC)
- Institutional Conflict of Interest (COI)
- Institutional Integrity and Risk Management (IIRM)
- Institutional Official (IO)
- Institutional Privacy Office (IPO)
- Institutional Privacy Officer
- Institutional Review Board Information System (IRBIS)
- Institutional Review Board (IRB)
- Interaction
- International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9CM)
- International Council for Harmonisation (ICH)
- Intervention
- Interventional study
- Investigation
- Investigational device
- Investigational Device Exemption (IDE)
- Investigational drug
- Investigational Drug Service (IDS)
- Investigational New Drug (IND)
- Investigational New Drug (IND) safety report
- Investigational plan
- Investigational product (IP)
- Investigator
- Investigator agreement
- Investigator-initiated study
- Investigator's Brochure (IB)
- In vitro
- In vivo
- IRB application
- IRB approval
- IRB Authorization Agreement (IAA)
- IRB expiration
- IRB of record
- Just-in-Time (JIT)
- Key information
- Label
- Labeling
- Legally Authorized Representative (LAR)
- Legally effective informed consent
- Life-threatening adverse event
- Limited dataset
- Lineberger Comprehensive Cancer Center (LCCC)
- Local considerations
- Long form
- Longitudinal study
- Long Term Follow-Up (LTFU)
- Lost to Follow Up (LTFU)
- Manual of procedures (MOP)
- Material transfer agreement (MTA)
- Medical device
- Medical monitor
- Medical record
- Medical Record Number (MRN)
- Memorandum of understanding (MOU)
- Minimal risk
- Minor
- Monitor
- Monitoring
- Monitoring report
- Multicenter study
- Multisite study
- National Institutes of Health (NIH)
- New Drug Application (NDA)
- NIH National Library of Medicine (NLM)
- NIH Public Access Policy
- No Cost Extension (NCE)
- Nonclinical study
- Noncompliance
- Nondisclosure agreement (NDA)
- Nonsignificant Risk (NSR) medical device
- Nonsignificant Risk (NSR) medical device study
- North Carolina Translational and Clinical Sciences (NC TraCS) Institute
- Not Human Subjects Research (NHSR)
- Notice of Award (NOA)
- Notice of privacy practices
- Not reasonably available (as it applies to locating a parent)
- Observational study
- Observational Study Monitoring Board (OSMB)
- Office for Human Research Protections (OHRP)
- Office for Innovation, Entrepreneurship and Economic Development (IEED)
- Office of Clinical Trials (OCT)
- Office of Human Research Ethics (OHRE)
- Office of Research Communications (ORC)
- Office of Research Development (ORD)
- Office of Research Information Systems (ORIS)
- Office of Research (OoR)
- Office of Research Support and Compliance (ORSC)
- Office of Sponsored Research (OSR)
- Office of Technology Commercialization (OTC)
- Office of the Vice Chancellor for Research (OVCR)
- Office of University Counsel (OUC)
- Off-label use
- On-site monitoring
- Open-label trial
- Organizational Conflict of Interest (COI)
- Outcome
- Package insert
- Parent
- Parental permission
- Participant
- Participant engagement
- Participant partners
- Participating site
- Patient Centered Outcomes Research Network (PCORnet)
- Patient level data
- Patient registry
- Personnel Profile and Training System (PaTS)
- Pharmacogenomics
- Pharmacokinetics (PK)
- Phase
- Phase 1
- Phase 2
- Phase 3
- Phase 4
- Pilot study
- Placebo
- Placebo effect
- Plagiarism
- Plain language
- Possibly related to the research
- Pragmatic trial
- Preclinical research
- Principal Investigator (PI)
- Privacy
- Privacy board
- Privacy Rule
- Private information
- Procedure
- Program officer
- Promptly Reportable Information (PRI)
- Prospective study
- Protected Health Information (PHI)
- Protocol
- Protocol amendment
- Protocol deviation
- Protocol Review Committee (PRC)
- PubMed Central (PMC)
- Quality Assurance (QA)
- Quality Control (QC)
- Quality Improvement (QI)
- Query
- Questionnaire
- Quorum
- Radiation Safety Subcommittee (RSS)
- Radioactive Drug Research Committee (RDRC)
- RAMSeS (Research Administration Management System & electronic Submission)
- Randomization
- Randomized
- Reasonable possibility
- Recruitment
- Recruitment period
- Recruitment plan
- Recruitment status
- REDCap (Research Electronic Data Capture)
- Registry study
- Regulatory binder
- Reliance agreement
- Relying Institution
- Repository
- Research
- Research administrator
- Research Compliance Program (RCP)
- Research Coordination & Management Unit (RCMU)
- Researcher
- Research misconduct
- Research personnel
- Research plan
- Research registry
- Research study
- Research team
- Research team members
- Responsible conduct of research
- Retention
- Retention plan
- Retrospective study
- Reviewing IRB
- Reviewing IRB Institution
- Rights
- Risk
- Risk-based monitoring
- Root cause
- Root Cause Analysis (RCA)
- Safety
- Safety and Security Committee
- Schedule of activities (SOA)
- Schedule of Assessments
- School of Medicine (SOM)
- Scientific Review Committee (SRC)
- Screen failure
- Screening
- Screening log
- Sensitive Information (SI)
- Serious Adverse Event (SAE)
- Serious and Unexpected Suspected Adverse Reaction (SUSAR)
- Serious noncompliance
- Severity
- Short form
- Short form consent
- Side effects
- Significant Risk (SR) medical device
- Significant Risk (SR) medical device study
- Single blinding
- Single IRB (sIRB)
- Site Initiation Visit (SIV)
- Site investigator
- Site Master File (SMF)
- SMART IRB
- Society of Clinical Research Associates (SoCRA)
- SOM Conflict of Interest Committee (COIC)
- Source data
- Source documents
- Sponsor
- Sponsored Program Office (SPO)
- Sponsored Research Agreement (SRA)
- Sponsor-investigator
- Standard of Care (SOC)
- Standard Operating Procedure (SOP)
- Stopping rules
- Stratification
- Structured data
- Study
- Study Coordinator (SC)
- Study design
- Study documentation
- Study monitor
- Study population
- Study site
- Sub-investigator
- Subject
- Subject binder
- Subject chart
- Subject identification number/code
- Suspected Adverse Reaction
- Suspension
- Target enrollment
- Termination
- Test article
- Therapeutic misconception
- Tolerability
- Toxicity
- Trial
- Trial Master File (TMF)
- Unanticipated Adverse Device Effect (UADE)
- Unanticipated Problem Involving Risk to Subjects or Others (UPIRSO)
- UNC Health
- UNC Health Network Entities
- UNC Health Privacy Office
- Underserved population
- Unexpected adverse event
- University of North Carolina at Chapel Hill
- Visit
- Volunteer
- Vulnerable populations
- Washout Period
- Welfare
- Well-being
- Work Instruction (WI)
- Written
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