Essential Acronyms in Clinical Research
Clinical research is a demanding field where precision and standardization are crucial to ensure reliable and reproducible results. Professionals in this sector use numerous acronyms and technical terms daily for protocols, reports, or discussions with international partners. While these abbreviations are practical, they can often seem confusing to newcomers or those unfamiliar with the field.
The keywords are grouped into several categories:
1. General Acronyms: Terms frequently used by research teams.
2. Phases and Study Types: The various stages and methodologies of clinical trials.
3. Regulations and Organizations: Agencies and laws governing clinical research.
4. Data and Reports: Tools and processes related to data collection and analysis.
5. Drugs and Devices: Terms specific to investigational products and medical devices.
Whether you are collaborating with a Clinical Research Organization (CRO), participating in a trial as an investigator, or seeking to better understand study results, this blog article will guide you in mastering the essential vocabulary of clinical research.
General Acronyms
ADR - Adverse Drug Reaction
A harmful response to a drug administered under normal conditions.
AE - Adverse Event
An undesirable medical event occurring in a patient during a clinical study.
CI - Chief Investigator
The lead investigator responsible for a clinical study across multiple sites.
CRA - Clinical Research Associate
A professional supervising clinical trials to ensure compliance.
CRC - Clinical Research Coordinator
Coordinates clinical trial activities at a specific site.
CRF - Case Report Form
A structured form completed by investigators or medical staff to document clinical data
eCRF - Electronic Case Report Form
An electronic version of the case report form.
CRO - Clinical Research Organization
An organization managing clinical trials on behalf of sponsors.
CTA - Clinical Trial Agreement
A legal agreement between parties involved in a clinical trial.
EC - Ethics Committee
A committee overseeing the ethical aspects of a clinical study.
GCP - Good Clinical Practice
International standards ensuring the quality of clinical studies.
IRB - Institutional Review Board
A committee reviewing ethical aspects and protecting participants.
LAR - Legally Authorized Representative
A person legally authorized to consent on behalf of a participant.
PI - Principal Investigator
The person responsible for conducting the clinical study.
SAE - Serious Adverse Event
A severe undesirable medical event requiring special attention.
SOP - Standard Operating Procedure
Standardized documented procedures. Document what you do, do what you document.
BA/BE - Bioavailability/Bioequivalence
Studies comparing the availability of a drug or its generic equivalent.
FIM - First-in-Man
The first administration of a compound to humans.
NIS - Non-Interventional Study
A study where no experimental treatment is administered.
P1, P2, P3, P4 - Phases 1 to 4
Successive phases of evaluating a drug or medical device.
PD - Pharmacodynamics
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PK - Pharmacokinetics
The study of the fate of drugs in the body.
PMS - Post-Marketing Surveillance
Monitoring adverse effects after a product is marketed.
RCT - Randomized Controlled Trial
A clinical trial where participants are randomly assigned to groups.
Regulations and Organizations
CDISC - Clinical Data Interchange Standards Consortium
Consortium setting standards for clinical data exchange.
EMA - European Medicines Agency
European regulatory body for medicines.
FDA - Food and Drug Administration
U.S. regulatory body overseeing drugs and food.
HIPAA - Health Insurance Portability and Accountability Act
U.S. law governing health data confidentiality.
ICH - International Council for Harmonisation
An organization setting standards for clinical trials.
ICH is the organization responsible for creating the ICH E6 GCP guideline and other harmonized standards.
ISO - International Organization for Standardization
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MHRA - Medicines and Healthcare products Regulatory Agency
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Data and Reports
CSR - Clinical Study Report
Report detailing the results of a clinical trial.
DM - Data Management
The design and configuration of forms and controls to simplify data collection, ensure data quality, and support efficient monitoring.
DMC - Data Monitoring Committee
Committee monitoring data to ensure study integrity.
DSMB - Data Safety Monitoring Board
Committee monitoring data safety to protect patients.
ePRO - Electronic Patient-Reported Outcome
Patient-reported outcomes collected through electronic tools.
RWE - Real-World Evidence
Evidence obtained from real-world (ie subject at home, work, daily life).
SAS - Statistical Analysis System
Software used for statistical analyses.
SDV - Source Data Verification
The process of verifying that data manually transcribed from paper records into the eCRF matches the original source.
Drugs and Devices
ANDA - Abbreviated New Drug Application
Application for a generic drug.
BLA - Biologics License Application
Application for approval of a biological product.
IMP - Investigational Medicinal Product
Experimental drug used in a clinical study.
IND - Investigational New Drug
A new drug under experimental development.
IP - Investigational Product
Experimental product used in a clinical study.
MD - Medical Device
Product category. An instrument or implant used to prevent, diagnose, or treat diseases without pharmacological means.
MD Class I,II,III - Medical Devices Categories
Risk-based classification of medical devices (e.g., Class I, II, III in the U.S.; Class I, IIa, IIb, III in the EU) with legal implications for clinical trials.
UDI - Unique Device Identifier
Unique identifier for a medical device.
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