2022/09/15

Summary of acronym list in clinical trial

A clinical trial is trial conducted with patients, evaluating new treatments, drugs or devices, in patients. They can also test improved procedures of treating, preventing, screening and diagnosing disease in patients.

While conducting clinical trials, it uses a multitude of acronyms and abbreviations usually. For those who are not familiar with clinical trials, these acronyms will block for understanding.

Here, we provide some of common acronyms and terminology you will encounter. This list should provide you can get into the process of clinical trial easier.

Here’s a list of common ones.:

ADR	Adverse Drug Reaction
AE	Adverse Event
COV	Close out visit
CRC	Clinical Research Coordinator
CRF	Case Report Form
CRO	Contract Research Organization
CRA	Clinical Research Associates
CT	Clinical Trial
DM	Data Manager
DSMB	Data and Safety Monitoring Board
eCRF	Electronic Case Report Form
EDC	Electronic Data Capture
FDA	Food and Drug Administration
GCP	Good Clinical Practice
GMP	Good Manufacturing Practice
IB	Investigator’s Brochure
ICF	Informed Consent Form
ICH	International Conference on Harmonization
IEC	Independent Ethics Committee
IND	Investigational new drug
IP	Investigational product
IRB	Institutional Review Board
NDA	New drug application
PI	Principal Investigator
QM	Quality management
QV	Qualification visit
RA	Research Assistant
RCT	Randomized Controlled Trial
SADR	Serious Adverse Drug Reaction
SAE	Serious Adverse Event
SAS	Statistical Analysis System
SDV	Source Data Verification
SIV	Site initiation visit
SMV	Site monitoring visit
SPSS	Statistical Package for the Social Sciences
SSV	Site Selection Visit
Sub-I	Sub-Investigator
SUSAR	Suspected Unexpected Serious Adverse Reaction
TMF	Trial Master File
UAT	User Acceptance Testing

Do you want to plan the clinical trial for your drug/medical device which comply with regulations?

Do you want to associate suitable hospitals with your clinical trial?

Do not hesitate to contact Talent, we will not only support you throughout the market pre-accession process, but we will also provide flexible, innovative, scalable solutions to meet your requirements of clinical trials!