Clinical Research Acronyms and Abbreviations You Should Know

April Schultz
Content Marketing Manager, Forte
March 8th, 2018

We all know there are numerous acronyms and abbreviations used in clinical research. While some can be easily deciphered, others may take some searching to find their meaning. Particularly with the recent surge in electronic systems and regulations, it can be hard to keep track of necessary abbreviations and terms.

Whether you’re new to the clinical research world or need a refresher, here’s a condensed list of common acronyms and abbreviations you may come across.

AACI: Association of American Cancer Institutes

ADR: Adverse Drug Reaction

AE: Adverse Event

ALCOA: Attributable, Legible, Contemporaneous, Original, Accurate

AMC: Academic Medical Center

API: Active Pharmaceutical Ingredient

API: Application Program Interface

ARO: Academic Research Organization

BSM: Biospecimen Management

CAPA: Corrective and Preventive Action

CBER: Center for Biologics Evaluation and Research

CCEA: Complete, Consistent, Enduring, Available

CCR: Center for Cancer Research

CCSG: Cancer Center Support Grant

Related webinar: Examining the NCI Cancer Center Support Grant

CCTO or CTO: Centralized Clinical Trials Office or Clinical Trials Office

CDASH: Clinical Data Acquisition Standards Harmonization

CDER: Center for Drug Evaluation and Research

CDM: Clinical Data Management

Related article: “Improve Data Quality with 5 Fundamentals of Clinical Data Management”

CDRH: Center for Devices and Radiological Health

CDS: Clinical Data System

CDUS: Clinical Data Update System

CFR: Code of Federal Regulations

CMO: Contract Manufacturing Organization

CMS: Centers for Medicare & Medicaid Services

CRA: Clinical Research Associate

CRC: Clinical Research Coordinator

Related article: “Deciphering the CRC Career Path: Key Skills and Responsibilities”

CRF: Case Report Form

CRMS: Clinical Research Management System

CRO: Contract Research Organization

CSO: Contract Safety Organization

CSR: Clinical Study Report

CTCAE: Common Terminology Criteria for Adverse Events

CTMS: Clinical Trial Management System

Learn more about Forte’s enterprise CTMS, OnCore Enterprise Research.

CTRP: Clinical Trials Reporting Program

CTSA: Clinical and Translational Science Award

DHHS: Department of Health and Human Services

DM: Data Manager

Related webinar: Add Data Management to Your Clinical Research Resume and Expand Your Professional Potential

DMC: Data Monitoring Committee

DSMB: Data and Safety Monitoring Board

EC: Ethics Committee

eCRF: Electronic Case Report Form

EDC: Electronic Data Capture

Learn more about Forte’s electronic data capture system, Forte EDC.

EHR: Electronic Health Record

EMR: Electronic Medical Record

ePRO: Electronic Patient-Reported Outcomes

eTMF: Electronic Trial Master File

FAIR: Findable, Accessible, Interoperable, Reusable

FDA: Food and Drug Administration

FWA: Federal-wide Assurance

GCP: Good Clinical Practice

GCRC: General Clinical Research Center

GDP: Good Documentation Practice

HIPAA: Health Insurance Portability and Accountability Act

ICF: Informed Consent Form

Related webinar: The Art of Conducting an Effective Informed Consent Discussion

ICH: International Council for Harmonization

IDE: Investigational Device Exemptions

IEC: Independent Ethics Committee

IHCRA: In House Clinical Research Associate

IIT: Investigator Initiated Trial

IND: Investigational New Drug (Application)

IRB: Institutional Review Board

ITT: Intent to Treat

IVRS: Interactive Voice Response System

IWRS: Interactive Web Response System

LTFU: Long Term Follow Up

LRAA: Local Regulatory Affairs Associate

MAC: Medicare Administrative Contractor

MCA: Medicare Coverage Analysis

Related webinar: Steps to Operationalize Your Coverage Analysis and Achieve Compliant Billing Outcomes

MRN: Medical Record Number

NCI: National Cancer Institute

NDA: New Drug Application

NHV: Normal Healthy Volunteer

NIH: National Institutes of Health

NLM: National Library of Medicine

OCT: Office of Clinical Trials

OHRP: Office for Human Research Protections

OSR: Outside Safety Report

PC: Protocol Coordinator

PD: Protocol Director

PHI: Protected Health Information

PI: Principal Investigator

PRMC: Protocol Review and Monitoring Committee

PRMS: Protocol Review and Monitoring System

QC: Quality Control

QCT: Qualifying Clinical Trial

SAE: Serious Adverse Event

SC: Study Coordinator

SDR: Source Document Review (Also Source Data Review)

SDTM: Study Data Tabulation Model

SDV: Source Document Verification

SIF: Site Investigator File

SMO: Site Management Organization

SOE: Schedule of Events

SOP: Standard Operating Procedure

Related article: “Data Collection in Clinical Trials: 4 Steps for Creating an SOP”

SPOREs: Specialized Programs for Research Excellence

SRB: Scientific Review Board

SRC: Scientific Review Committee

SUSAR: Suspected Unexpected Serious Adverse Reaction

SVT: Subject Visit Template

TMF: Trial Master File

TMO: Trial Management Organization

UADE: Unanticipated Adverse Device Effect

UADR: Unexpected Adverse Drug Reaction

Is there an abbreviation or acronym you see regularly in clinical research that isn’t listed here? If so, feel free to add it to the comments and define it.

To learn more about the fundamentals of clinical research, check out these free resources:

You can also explore the clinical trial industry’s top challenges and hear what over 900 research professionals think of the state of clinical research today. Download our free eBook State of the Clinical Research Industry Report.

 

A version of this blog post was previously published on December 20, 2013. 

32 Comments

32 thoughts on “Clinical Research Acronyms and Abbreviations You Should Know

  1. CSO: Contract Safety Organization

    SVT: Subject Visit Template

    LRAA: Local Regulatory Affair Associate

    IHCRA: In House Clinical Research Associate

  2. CMS: Centers for Medicare & Medicaid Services
    IDE: Investigational Device Exemptions
    MAC: Medicare Administrative Contractor
    MCA: Medicare Coverage Analysis
    PHI: Protected Health Information
    UADE: Unanticipated adverse device effect

  3. Thanks Kristina,

    This blog post will help readers for sure. I would also request you to add few more terms mentioned below (if you like):

    RBC – Red Blood Count
    DAWN – Drug Abuse Warning Network
    DEN – Drug Experience Network
    IPRA – International Product Registration Application
    DJD – Degenerative Joint Disease
    DSM – Diagnostic and Statistical Manual

    Keep up the good work.

    1. Hi, may I check with you what does SSDDL means? been searching online but I cant get the definition.
      Thanks

  4. What about:

    ITT – Intent to Treat
    mITT – Modified Intent to Treat
    SDTM – Study Data Tabulation Model
    ADaM – Analysis Data Model
    CDER – Center for Drug Evaluation and Research
    CBER – Center for Biologics Evaluation and Research
    CDRH – Center for Devices and Radiological Health
    ICH – International Council for Harmonization

  5. There are soooo many others that could be added to such a list. Check out other online lists such as: https://www.rochester.edu/ohsp/documents/rsrb/pdf/Acronyms.pdf
    http://www.wikidoc.org/index.php/Acronyms_of_Clinical_Trial_Terms

    ADME: absorption distribution metabolism excretion
    BLA: Biologics License Application
    DMP: data management plan
    DTS: data transfer specification
    GMP; good manufacturing practices
    GLP: good laboratory practices
    GxP: good x practices
    eDI: electronic data interchange
    IA: interim analysis
    IxRS: interactive x response systems (web, voice. …)
    SAP: statistical analysis plan
    CDISC: clinical data interchange standards consortium
    PLA: product license application

    (from research Discovery side of the house)
    SAR: structure activity relationship
    QSAR: quantitative structure activity relationship

  6. Hi April,
    Very interesting list.
    I have here some additions:
    CCRA: Certified Clinical Research Associate
    EUCTD: European Clinical Trial Directive
    ECG: Electrocardiogram
    EPR: Early Phase Response
    LPR: Late Phase Response
    IUD: Intrauterine Device.
    MedDRA: Medical Dictionary for Regulatory Activities.
    DLT: Dose-limiting toxicity
    SD: Standard Deviation
    EEG: Electro-encephalogram
    EMEA: European Medicines Evaluation Agency.
    SEP: Study Execution Plan,
    COP: Clinical Operations Plan
    CT: Computed tomography
    DNA: Desoxyribonucleic acid.
    EF: Ejection Fraction.
    IRB: Institutional Review Board.
    WHO: World Health Organization
    ULN: Upper Limit of Normal

  7. Do you know “MEDIBREV”, enormous, useful and free international dictionnary of medical acronyms on iPhone?

  8. Hi, April,

    “CTCAE: Common Terminology Criteria for Adverse Effects” is incorrect–it’s

    “CTCAE: Common Terminology Criteria for Adverse EVENTS”

    Regards,

    Susan E Caldwell, PhD
    Medical Writer Consultant
    Biotech Ink, LLC

  9. CFR: Country Feasibility Report
    IP: Investigational Product
    NIMP: Non-internventional medicinal product
    PTAV: Pre-trial Assessment Visit
    RBM: Risk-based Monitoring

  10. Hi,

    Great list!

    suggestions:
    CEC = Clinical Events Committee
    DM = Data Management
    FAS = Full Analysis Set
    ISO = International Organization for Standardization
    IVDD = In-vitro Diagnostic Device
    MD = Medical Device
    PD = Protocol Deviation OR Pharmacodynamics
    PK = Pharmacokinetics
    PPP/PPS = Per Protocol Population / Set
    PRO = Patient Reported OUtcomes
    QoL = Quality of Life
    RCT = Randomized Control Trial
    SADE = Serious Adverse Device Event
    SAP = Statistical Analysis Plan

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