Glossary
Clinical research terms explained
Open dictionary of the most used terms in clinical methodology, statistics, compliance, and technology.
Methodology
Clinical monitor
CRA — professional verifying trial execution.
CRF
Case Report Form — document (paper or electronic) to collect subject data.
CRO
Contract Research Organization — runs trials on behalf of sponsors.
Double-blind
Neither subject nor investigator knows the assignment.
Exclusion criteria
Characteristics that rule out participation.
Inclusion criteria
Characteristics a subject must meet to participate.
Phase I
First clinical trial phase: safety in humans.
Phase II
Second phase: preliminary efficacy and dose-finding.
Phase III
Pivotal phase: efficacy vs. standard of care.
Phase IV
Post-marketing: pharmacovigilance in real-world use.
Placebo
Substance or procedure with no active pharmacological effect.
Primary endpoint
Main variable on which the trial decision is based.
Principal Investigator
PI — responsible for trial conduct at a site.
Protocol
Document describing the trial: objectives, design, methodology.
SDV
Source Data Verification — comparing CRF data to primary source.
Secondary endpoint
Additional outcomes, not basis for primary decision.
Site
Center where the trial is conducted.
Statistics
ANOVA
Analysis of variance — comparison of 3+ group means.
Block randomization
Technique balancing assignment within fixed-size blocks.
Chi-square
Test of independence/association between categorical variables.
Confidence interval
Range of plausible values for a population parameter.
Hazard ratio
HR — measure of effect in survival analysis.
ITT
Intention-to-treat — analysis by assigned group, not received.
Kaplan-Meier
Non-parametric estimator of the survival function.
Linear regression
Linear model of continuous variable on predictors.
Logistic regression
Regression for binary dependent variable.
Odds ratio
OR — association measure between exposure and binary outcome.
P-value
Probability of observing the result if the null hypothesis were true.
Per-protocol
Analysis only of subjects completing treatment per protocol.
Randomization
Random assignment of subjects to treatment groups.
Relative risk
RR — ratio of risks between exposed and unexposed.
Sample size
Number of subjects needed for a statistical goal.
Statistical power
Probability of detecting an effect that truly exists.
Stratification
Randomize within subgroups defined by prognostic variables.
t-test
Test of mean differences between two groups.
Regulatory
21 CFR Part 11
FDA regulation on electronic records and signatures.
AE
Adverse Event — any untoward medical occurrence.
ALCOA+
Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate.
Audit trail
Immutable record of actions on data.
BAA
Business Associate Agreement — required by HIPAA.
DPA
Data Processing Agreement — contract between controller and processor.
DPIA
Data Protection Impact Assessment — GDPR impact review.
DPO
Data Protection Officer.
EMA
European Medicines Agency — EU regulatory agency.
FDA
US Food and Drug Administration.
GDPR
General Data Protection Regulation (EU 2016/679).
HIPAA
US federal law on medical information privacy and security.
ICH-GCP
International Council for Harmonisation — Good Clinical Practice.
Informed consent
Process by which the subject agrees after adequate information.
IRB
Institutional Review Board — ethics committee for research.
Pharmacovigilance
Activity of detecting, assessing, and preventing adverse effects.
Protocol amendment
Formal modification of the protocol after approval.
SAE
Serious Adverse Event.
Sponsor
Person or entity taking responsibility for a clinical trial.
TMF
Trial Master File — essential documents archive.