Common Terms in Clinical Trial Research

Baseline: This provides a basis for assessing changes in subsequent clinical research assessments and observations. Physical exam, Lab results, and other assessments are recorded as a reference point at your first visit.

Concomitant Medications (ConMeds): Prescriptions, over-the-counter medications, and supplements a clinical research participant has taken along with study interventions. This will include all medications you are taking and will continue to take throughout the study. You will be required to report all medication changes to the study site staff.

Double-blind Study: A clinical research study where neither the participant nor the clinical researcher knows what study treatment the participant is receiving.

Single-blind Study: A clinical research study where the research investigator will know what treatment you receive. The treatment will not be known by the clinical research participant.

Study Intervention: The treatment given to study participants. This is also known as Investigational Product (IP), or Study Drug.

Randomization: This is when you are enrolled in the main portion of the clinical research study, and the study intervention has started.

Questionnaire: A list of medical and clinical research study relevant questions for the study participant to answer. This is usually a requirement put in place by the clinical study sponsor.

Sponsor: The group or company in charge of or that pays for a clinical research study.

Protocol: A document outlining a complete description of a clinical research study. This will include the plans and procedures that the clinical study will require.

Probability: The likelihood or chance that a result may occur within a specified group.

Primary Endpoint: The primary study result measured that is used to answer the main research question.

Open Label: A type of clinical research study where the participants and research staff know which treatment you are given. This is the opposite of a blinded clinical study.

Objective: The purpose or goal of a clinical research study.

Efficacy: How well a clinical study treatment works in a particular study.

Discontinue (Participant): To remove a study participant from a clinical research study.

Discontinue (Study Treatment): To stop the clinical study treatment with a participant.

Blood Draw: Taking a sample of blood from a potential clinical research study participant using a needle. This is a requirement for most clinical studies.

Adverse Event: Any health problem with a clinical study participant that arises during a clinical research study.