Reference
Clinical Trial Glossary
Plain-language definitions of cardiovascular clinical trial terminology — for patients and sponsor teams.
Clinical trials use specialized terminology that can be confusing for patients and unfamiliar to staff joining the field. This glossary defines the terms you'll encounter most often in cardiovascular trials at Amavita Research and other sites. Each definition is written in plain language, with a longer technical note where it helps.
A
- Adverse Event(AE)
- Any new or worsening medical problem that happens during a trial. Reported to the trial team and reviewed for whether it's related to the study treatment.
- Ambulatory Blood Pressure Monitoring(ABPM)
- A 24-hour blood pressure recording using a portable monitor. Used in hypertension trials to capture true blood pressure across daily activities.
- Arm (study arm)
- One of the groups in a randomized trial. For example, a 2-arm trial might have a "treatment arm" and a "control arm."
B
- Baseline
- Your starting state measured before you receive any study treatment. Used as the reference point for measuring change later in the trial.
- Blinded (Single-blind, Double-blind)
- When patients (single-blind) or both patients and trial team (double-blind) don't know which study arm a patient is assigned to. Reduces bias in measuring outcomes.
C
- Case Report Form(CRF)
- The document where the trial team records your data at each visit. Increasingly electronic (eCRF).
- Clinical Research Coordinator(CRC)
- The trial team member who manages day-to-day study logistics, schedules visits, and is usually your main contact.
- Confidentiality Agreement(CDA)
- A legal agreement between the sponsor and the trial site protecting trial information from disclosure. Signed before detailed protocol review.
- Consent (Informed Consent)
- The process by which you receive complete information about a trial and voluntarily agree to participate. Signed before any study procedures.
- Contract Research Organization(CRO)
- An organization that sponsors hire to manage trial operations across sites. Some CROs also own and operate sites directly.
- Control Arm
- The group in a trial that receives standard care or placebo rather than the new treatment, used as comparison.
D
- Data Safety Monitoring Board(DSMB)
- An independent group of physicians and statisticians who review trial data periodically and can recommend stopping a trial early for safety or efficacy reasons.
- Diagnostic Procedure
- A test done to identify or measure a medical condition (ECG, echocardiogram, blood test). Many trials include diagnostic procedures at scheduled visits.
E
- Eligibility Criteria
- The medical and personal characteristics that determine who can or cannot enroll in a specific trial. Includes inclusion criteria (you must have these) and exclusion criteria (you can't have these).
- Endpoint (Primary, Secondary)
- The measurable outcome a trial is designed to detect. A "primary endpoint" is the main thing the trial is trying to prove; "secondary endpoints" are additional outcomes.
- Enrollment (First Patient Enrolled, FPE)
- The point at which the first patient at a site signs consent and begins the study.
F
- First-In-Human(FIH)
- The first time a new treatment is given to human participants, after preclinical animal and laboratory testing.
- FDA Form 483
- A list of observations issued by the FDA after a site inspection. Findings range from minor to significant. A "clean inspection" means no Form 483 was issued.
G
- Good Clinical Practice(GCP)
- The international standard for conducting clinical trials ethically and scientifically. The current version is ICH-GCP E6(R3).
H
- HIPAA (Health Insurance Portability and Accountability Act)
- U.S. law that protects the privacy of your medical information. Trial sites are required to follow HIPAA for all participant data.
I
- ICH-GCP E6(R3)
- The current International Council for Harmonisation Good Clinical Practice guideline. Sets the standard for how trials should be designed, conducted, recorded, and reported.
- Informed Consent Form(ICF)
- The document you sign to confirm you understand the trial and voluntarily agree to participate.
- Institutional Review Board(IRB)
- An independent committee that reviews and approves every trial before patients can enroll. Required by federal regulations.
- Investigational Product(IP)
- The drug, device, or treatment being tested. Also called study drug or study medication.
- Investigator (Principal Investigator, PI)
- The physician responsible for conducting the trial at a specific site. Signs off on protocol decisions and patient safety.
M
- Master Services Agreement(MSA)
- A contract between a sponsor and a CRO or site organization that sets terms for multiple future trials. Speeds up individual trial contracting.
- MedDRA
- A standardized medical terminology used for coding adverse events across trials.
N
- NCT Number
- The identifier ClinicalTrials.gov assigns to every registered trial (e.g., NCT06369298). Use this to look up trial details on the ClinicalTrials.gov website.
O
- Open-Label
- A trial where everyone (patient and trial team) knows which study arm the patient is in. Different from blinded trials.
P
- Phase 1, 2, 3, 4
- The four phases of clinical trial development. Phase 1: first in humans, focus on safety. Phase 2: small group, tests early efficacy. Phase 3: large studies for approval. Phase 4: after approval, long-term monitoring.
- Placebo
- A treatment with no active ingredient (often a sugar pill or saline infusion) used as a comparison in some trials.
- Protocol
- The detailed plan for a trial — who can enroll, what treatments are given, what measurements are taken, when. Approved by IRB before enrollment begins.
- Protocol Deviation
- Any departure from the trial protocol. Minor deviations are documented; major deviations may affect a patient's eligibility to remain in the trial.
Q
- Quality Assurance(QA)
- The systematic processes a site uses to ensure trial data and conduct meet GCP standards.
R
- Randomization
- Random assignment of patients to study arms, used to reduce bias. Usually done by computer after consent.
- Run-in Period
- A period before the main trial where patients are observed or given placebo to confirm eligibility or adherence before randomization.
S
- Sample Size
- The number of participants a trial enrolls. Calculated to give the study statistical power to detect the planned effect.
- Screen Failure
- A patient who consented and was screened but didn't meet eligibility criteria. Common in trials with strict criteria.
- Site (Trial Site)
- The physical location where the trial is conducted. A "site" can be a hospital, academic medical center, or independent investigator-led practice like Amavita Research.
- Sponsor
- The company or organization paying for and managing the trial. Usually a pharmaceutical or medical-device company, sometimes a nonprofit or government agency.
- Standard of Care
- The current accepted treatment for a condition. Trials usually compare new treatments against standard of care.
- Study Visit
- A scheduled appointment during the trial. Visits typically take 1-3 hours and include measurements, sample collection, and treatment administration.
T
- Treatment Arm
- The group in a randomized trial that receives the new treatment being tested.
V
- Vital Signs
- Standard measurements at every visit: blood pressure, heart rate, respiratory rate, temperature, weight.
W
- Washout Period
- A period when a patient stops taking a previous medication before starting the trial, to clear the previous treatment from the body.
- Withdrawal
- When a patient leaves the trial before it ends, either voluntarily or because the trial team decides it's in the patient's interest. You always have the right to withdraw.
Need a term defined that's not here? Email us at research@amavita.health and we'll add it.
Keep exploring
More resources for patients and sponsors evaluating cardiovascular clinical trials.