Before enrolling in any clinical trial, all participants must meet specific eligibility criteria. These criteria are set by the study’s sponsor and reviewed by ethics committees to ensure participant safety and scientific accuracy.

At DecenTrialz, we introduce you to these eligibility principles during the pre-screening stage so that you can make informed decisions and avoid being matched with studies that are not appropriate for your individual profile.

What does “Eligibility” mean in a clinical trial?

In the context of clinical research, eligibility refers to the defined rules that determine who can or cannot participate in a particular study. These rules are based on:

• The objectives and scientific goals of the study
• The treatment or intervention being tested
• Safety considerations specific to the trial
• Characteristics required for valid data collection

Eligibility criteria are developed by the trial sponsor—such as a pharmaceutical or biotechnology company—and reviewed by Institutional Review Boards (IRBs) and regulatory agencies.

While formal eligibility is determined by the research site during screening, DecenTrialz uses a general version of these criteria in its pre-screener to help guide trial matching.

Two Types of Criteria: Inclusion and Exclusion

Eligibility is made up of two types of conditions that work together to define who can participate:

Inclusion criteria

These are the requirements you must meet in order to qualify for a study. Examples include:

• Being within a specific age range
• Having a diagnosis of the condition being studied
• Meeting certain health markers or lab values

Exclusion criteria

These are conditions or factors that would prevent you from joining a particular study, usually to protect your safety or ensure accurate results. Examples include:

• Having a co-existing medical condition that could interfere with the trial
• Being pregnant or breastfeeding
• Taking medications that may interact with the investigational treatment

See below [Inclusion & Exclusion Criteria] for more detailed examples and guidance.

Why eligibility criteria matter

These criteria are not intended to exclude individuals unfairly. Rather, they serve several essential purposes:

• Participant Safety: Minimizing health risks for volunteers
• Scientific Validity: Ensuring data collected reflects the research question
• Ethical Oversight: Guaranteeing fair treatment and regulatory compliance under IRB supervision

Even if you appear to meet most of the criteria, only the research site has the authority to confirm eligibility following a full review of your health history and study requirements.

How DecenTrialz supports the eligibility process

• We use simplified eligibility logic in the pre-screener to help suggest trials that may align with your profile
• You are never denied access to the platform if no match is found—you may update your responses at any time
• If you are uncertain about your eligibility, we encourage you to speak directly with a study team, as outlined in [Can I Speak to Someone Before Joining?]

Key Note: Eligibility is not a personal evaluation of your health, value, or importance. It is a safety-focused, scientifically determined process that ensures ethical and reliable clinical research. DecenTrialz helps you explore appropriate studies, but the final eligibility decision always rests with the clinical research team.

Inclusion & exclusion criteria

Every clinical trial is governed by a specific set of inclusion and exclusion criteria. These criteria determine who may be eligible to participate in a study and are critical for ensuring the safety of participants and the scientific reliability of the research.

Understanding these criteria can help you decide whether to move forward with a clinical trial opportunity.

What are inclusion criteria?

Inclusion criteria are the specific traits or conditions a person must meet to be considered for participation in a clinical trial. These criteria are selected to support the study’s scientific objectives and ensure participant safety.

Examples of common inclusion criteria:

• Being within a certain age range (e.g., 18 to 65 years)
• Having a confirmed diagnosis of the condition under study (e.g., Type 2 diabetes, asthma, depression)
• Meeting specific lab test results or symptom severity thresholds
• Willingness to comply with study procedures (e.g., attending clinic visits, using a mobile app, or wearing a monitoring device)
• Residing within a specific geographic radius from the trial site

Important: Meeting inclusion criteria does not guarantee that you will be accepted into the study. It means you may be considered for further screening.

What are exclusion criteria?

Exclusion criteria are the conditions, factors, or circumstances that disqualify someone from participating in a given study. These criteria are often established to minimize risks, prevent interference with study outcomes, or ensure participant well-being.

Examples of common exclusion criteria:

• Being pregnant or currently breastfeeding
• Having another serious medical condition (e.g., advanced kidney disease, active cancer)
• Taking medications that could interact with the investigational product
• Recent participation in another clinical trial (e.g., within the last 30 days)
• History of substance misuse or recent psychiatric hospitalization (depending on the study protocol)

These criteria are not personal judgments — they are protective measures designed in accordance with ethical research practices.

Why these criteria exist

Eligibility criteria are developed through careful planning by the study sponsor and reviewed by Institutional Review Boards (IRBs), ethics committees, and regulatory agencies such as the U.S. Food and Drug Administration (FDA). They are designed to:

• Safeguard participant health and minimize risk
• Ensure the investigational treatment is tested in a scientifically valid way
• Maintain consistency in study results by reducing confounding variables
• Comply with ethical and regulatory frameworks

How DecenTrialz applies these criteria

During the pre-screening process, DecenTrialz:

• Uses simplified versions of the inclusion and exclusion criteria to suggest trials that may be appropriate for your profile
• Does not make final eligibility decisions — this is always handled by the clinical research site after a detailed medical review
• Encourages you to ask questions and seek clarification if you are unsure about any eligibility factor

Key Note: Meeting inclusion criteria and avoiding exclusion criteria does not guarantee enrollment in a trial. The final determination is made solely by the clinical research team based on a comprehensive review of your medical information. DecenTrialz provides early guidance to support your exploration but does not approve or deny participation.

Healthy volunteer eligibility

Not all clinical trials are limited to individuals with a diagnosed medical condition. Many studies are specifically designed for healthy volunteers, individuals who do not have the condition being studied but are willing to participate in research that supports scientific advancement and public health.

This section outlines who qualifies as a healthy volunteer, the types of studies that may involve them, and how eligibility is determined.

Who Is considered a healthy volunteer?

A healthy volunteer is typically someone who:

• Has no chronic illness or relevant medical diagnosis
• Is not currently undergoing treatment for a serious condition
• Reports being in overall good physical and mental health
• Meets general eligibility criteria such as age, weight, lifestyle habits, and other non-medical factors

Some studies may still include additional requirements, such as:

• Body Mass Index (BMI) within a specific range
• No history of certain surgeries or substance use
• No recent participation in other clinical trials (e.g., within the last 30–90 days)

Eligibility is always defined by the research protocol and may vary from one study to another.

What do healthy volunteers contribute to?

Healthy volunteers are essential in a wide range of clinical research, particularly in:

• Phase 1 trials, which test new medications for safety, dosage, and side effects
• Preventive or wellness studies, such as vaccine trials or lifestyle interventions
• Behavioral and observational research, including studies involving digital tools, nutrition tracking, or wearable devices

By participating, healthy volunteers help researchers:

• Understand how investigational products interact with the human body
• Compare results between individuals with and without the condition being studied
• Generate baseline data that supports future medical breakthroughs

How matching works for healthy volunteers on DecenTrialz

If you indicate in the pre-screener that you are in good general health:

• The platform filters for trials actively seeking healthy volunteers
• You will not be shown condition-specific trials unless they allow participation from healthy individuals (e.g., as part of a control group)
• You may be matched with studies related to prevention, early diagnostics, general health, or lifestyle research

Even if you do not have a medical condition, you must still meet the study’s eligibility requirements. Final eligibility is confirmed by the research site after a formal screening process.

Is it safe to participate as a healthy volunteer?

Yes. All clinical trials — including those involving healthy volunteers — are subject to:

• Ethical oversight by Institutional Review Boards (IRBs)
• Compliance with national and international research regulations
• Mandatory informed consent processes

Before participating, you will receive:

• A clear explanation of potential risks, study procedures, and your rights
• Opportunities to ask questions at any time
• The ability to withdraw from the study for any reason, without penalty

Key Note: Healthy volunteers play a vital role in the advancement of medical science. Whether contributing to the development of safer treatments, preventive strategies, or digital health tools, your involvement supports future care innovations. DecenTrialz will only match you with studies suitable for individuals without a diagnosed condition, and participation is always voluntary.