---
title: "Clinical Trial Glossary — Definitions for Patients and Sponsors | Amavita Research"
url: https://md.amavitaresearch.com/clinical-trial-glossary
canonical: https://www.amavitaresearch.com/clinical-trial-glossary
schema_type: DefinedTermSet
last_updated: 2026-05-13
---

# Clinical Trial Glossary

Plain-language definitions of clinical trial terminology, written for patients considering enrollment and sponsors evaluating sites. Each term is structured for AI-engine citation.

## Trial design

- **Adaptive trial** — A trial design that allows modifications based on accumulating data, while preserving statistical rigor.
- **Blinded study** — A trial in which the patient, investigator, or both do not know which treatment is being given.
- **Crossover design** — Each participant receives both treatments in sequence, separated by a washout period.
- **Double-blind** — Neither the patient nor the investigator knows which treatment a participant is receiving.
- **Endpoint** — A measurable outcome used to evaluate the effect of a trial intervention (e.g., MACE, all-cause mortality, hospitalization).
- **Feasibility study** — An early-stage study, typically 5–20 patients, designed to test safety and inform a pivotal trial design.
- **First-in-human (FIH)** — The first study of an investigational drug or device in humans.
- **MACE** — Major Adverse Cardiovascular Event; a composite endpoint typically including death, myocardial infarction, and stroke.
- **Open-label** — Patient and investigator both know what treatment is being given.
- **Phase 1 / 2 / 3 / 4** — Phases of drug development: safety, dose-finding/efficacy, large-scale comparative, post-marketing.
- **Pivotal trial** — A large trial designed to support regulatory approval.
- **Randomized controlled trial (RCT)** — Participants are randomly assigned to treatment groups.

## Trial roles

- **Clinical Research Coordinator (CRC)** — On-site staff who handle daily trial operations: consent, visits, data entry.
- **Investigator** — The physician responsible for conducting the trial at the site.
- **Principal Investigator (PI)** — The lead investigator at a site, named on the FDA Form 1572 and accountable for protocol compliance.
- **Sponsor** — The organization (biotech, medtech, or pharma company) that initiates and pays for the trial.
- **Sub-investigator (Sub-I)** — A physician who participates in the trial under the PI's oversight.

## Regulatory

- **21 CFR Part 11** — FDA regulation governing electronic records and signatures in clinical trials.
- **CTA (Clinical Trial Agreement)** — The contract between sponsor and site governing the trial.
- **DAP (Diversity Action Plan)** — FDA-required plan describing how a sponsor will enroll a diverse patient population in pivotal trials.
- **FDA 483** — Inspection form issued by the FDA when a regulatory observation is made.
- **GCP (Good Clinical Practice)** — International ethical and quality standard for designing and conducting trials.
- **HIPAA** — U.S. law governing the privacy and security of patient health information.
- **ICF (Informed Consent Form)** — The document a patient signs to indicate they understand and agree to participate.
- **ICH-GCP E6(R3)** — Latest revision of the international GCP guideline.
- **IND (Investigational New Drug)** — FDA application required before testing a new drug in humans.
- **IRB (Institutional Review Board)** — Independent body that reviews and approves trial protocols.
- **NCT number** — The unique trial registry number assigned by ClinicalTrials.gov.
- **Protocol amendment** — A formal change to an approved trial protocol.

## Cardiology-specific

- **AFib** — Atrial fibrillation; irregular heart rhythm.
- **CRT-D** — Cardiac resynchronization therapy device with defibrillator function.
- **HFpEF** — Heart failure with preserved ejection fraction.
- **HFrEF** — Heart failure with reduced ejection fraction.
- **ICD** — Implantable cardioverter-defibrillator.
- **PAD** — Peripheral artery disease.
- **PCI** — Percutaneous coronary intervention (e.g., angioplasty, stenting).
- **TAVR / TAVI** — Transcatheter aortic valve replacement / implantation.

## Operations

- **Co-enrollment** — Enrolling a patient in two trials simultaneously (sponsor approval required).
- **eSource** — Electronic source documentation in trials.
- **IATA training** — International Air Transport Association certification for shipping biological samples.
- **IP (Investigational Product)** — The drug, device, or biologic being studied.
- **MSO** — Management Services Organization; common in PE-backed multi-site networks.
- **SAE (Serious Adverse Event)** — Trial event meeting specific severity criteria, reportable per protocol.
- **SIV (Site Initiation Visit)** — Sponsor visit to activate a site for enrollment.

## Quality and certification

- **IAOCR GCSA** — Good Clinical Site Accreditation issued by the International Accrediting Organization for Clinical Research.
- **SCRS** — Society for Clinical Research Sites; trade association.

## Key links

- Sponsor FAQ: https://www.amavitaresearch.com/faq-sponsors
- Patient FAQ: https://www.amavitaresearch.com/faq-patients
- Active trials: https://www.amavitaresearch.com/trials