Clinical Operations & Trials

Clinical operations and trials: Good Clinical Practice, protocols and IRBs, informed consent, endpoints, randomization and blinding, serious adverse events, and pharmacovigilance.

Key terms & definitions

23 terms in this pack

AMENDMENT

A formal change to an already-approved protocol

BLINDING

Masking who gets drug versus placebo to prevent bias

COHORT

A group of trial participants sharing a characteristic

COMPARATOR

The existing drug a new therapy is tested against

CONSENT

Informed ___: a participant's documented agreement to join

CTMS

Clinical Trial Management System tracking sites and progress (acronym)

DATALOCK

Freezing a clean database before the analysis begins

EDC

Electronic Data Capture system for trial data (acronym)

ELIGIBILITY

Inclusion/exclusion criteria deciding who can join a trial

ENDPOINT

The pre-defined outcome a trial measures to judge success

ENROLLMENT

Signing eligible patients into a trial

GCP

Good Clinical Practice, the quality standard for human trials (acronym)

INVESTIGATOR

The physician responsible for running a trial at a site

IRB

Ethics board protecting trial participants' rights and safety (acronym)

MONITORING

CRA visits that verify a trial's data and compliance

PASSTHROUGH

Trial cost billed to the sponsor at actual, like site or lab fees

PHARMACOVIGILANCE

The science of monitoring a drug's safety after dosing

PLACEBO

Inactive comparator given to a trial's control group

PROTOCOL

The master plan defining exactly how a trial is run

RANDOMIZE

To assign patients to arms by chance to reduce bias

SAE

Serious Adverse Event that must be reported promptly (acronym)

SITE

A clinic or hospital where trial patients are seen

SPONSOR

The company that initiates and funds a clinical trial