Clinical trial glossary

Clinical trial terms, explained plainly

Short definitions first, then what each term means in practice for the people running a study: sponsors, sites, data managers and monitors.

B C D G I M N O P R S

B

Regulatory

Biologics License Application (BLA)

The application to FDA to market a biological product in the US.

Study design

Biomarker

A measurable characteristic that indicates a biological process, disease or response to treatment.

C

Data and documents

Case Report Form (CRF)

The form, paper or electronic, that records the protocol-required data for each participant.

Study design

Clinical Trial Endpoints

The outcomes a trial measures to answer its questions: primary, secondary and exploratory.

Outcomes and measurement

COA Types: PRO, ClinRO, ObsRO, PerfO

The four types of clinical outcome assessment: PRO, ClinRO, ObsRO and PerfO.

D

Data and documents

Database Lock

The point where the trial database is closed to changes before final analysis.

G

Ethics and oversight

Good Clinical Practice (GCP)

The international ethical and scientific quality standard for clinical trials (ICH E6).

I

Ethics and oversight

Institutional Review Board (IRB)

The independent committee that reviews research to protect participants' rights and welfare.

Randomisation and supply

IRT / IWRS

Interactive response technology: systems that randomise participants and manage trial drug supply.

M

Outcomes and measurement

Minimal Clinically Important Difference (MCID)

The smallest change in an outcome that patients would consider meaningful.

N

Study design

Natural History Study

An observational study of how a disease progresses without the intervention being tested.

O

Regulatory

Orphan, Breakthrough and Fast Track

FDA programmes that support development of drugs for rare or serious conditions.

P

Study design

Pragmatic Clinical Trial

A trial designed to test effectiveness in real-world practice rather than ideal conditions.

R

Outcomes and measurement

Reference Interval (Normal Range)

The range of lab values expected in a healthy reference population, often called the normal range.

Monitoring and quality

Risk-Based Monitoring (RBM)

Focusing monitoring effort on the data and processes that matter most.

S

Study design

Sample Size Calculation

Working out how many participants a trial needs to detect the effect it is looking for.

Monitoring and quality

Source Data Verification (SDV)

Checking that CRF data matches the original source records.

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Data and documents

Ethics and oversight

Monitoring and quality

Outcomes and measurement

Randomisation and supply

IRT / IWRS

Regulatory

Study design

In-depth guides

More terms, explained in full guides

ALCOA+

The data integrity principles regulators apply to trial records.

21 CFR Part 11

FDA rules for electronic records and electronic signatures.

Computer system validation (CSV)

Showing a system is fit for its intended use.

eCOA

Electronic clinical outcome assessments.

RTSM

Randomisation and trial supply management.

CTMS

Clinical trial management systems, compared with EDC.

eTMF

Electronic trial master files, compared with EDC.

Decentralized clinical trial (DCT)

Trials with activities away from traditional sites.

ICH E6(R3)

The latest revision of Good Clinical Practice.

EU CTR

The EU Clinical Trials Regulation and CTIS.

Bayesian trial design

Designs that update evidence as data accrue.

Diversity action plan

Plans for enrolling representative populations.

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