Thousands of people volunteer to take part in clinical trials every year.

Our medical advances can only happen through the efforts of many people, especially the patients who volunteer for clinical trials. When considering a clinical trial, it may help to understand the process of participation to know what to expect. We want to help you, your family, and your physician make the right decision for you.

Prescreening

In prescreening, the team will check your health. If needed, they will run tests to find out if you meet the eligibility criteriaEligibility criteriaA set of requirements (characteristics) used to determine whether a person can enroll in a study [clinical trial]; the reasons a person can be included in, or excluded from a study; used to make sure that a study includes the right participants to help answer the research questions [For example, a study may be looking to include only people of a certain age or with a certain health condition. When all participants meet the same eligibility criteria, it is more likely that results of the study are caused by the intervention being tested and not by other factors or by chance]; See also Inclusion Criteria, Exclusion Criteria listed in the protocolProtocolClinical Study; Clinical trial; a study; a written description of the study details, plan and procedures; a detailed plan of how a new drug (vaccine) will be studied. The protocol is a written plan of a clinical trial, including the goals, design, and how it will answer the questions of the trial’s purpose. The team will also review with you the instructions for taking part in the trial.

Informed Consent

Informed consent is the process in which researchers talk with people who are thinking about enrolling, or have enrolled, in a clinical trial. They will have you read an informed consent form (ICF)Informed Consent form (IC)A document that provides information about the purpose of the study, possible risks and benefits, and the participant's rights and responsibilities. Signing the consent form means that the person agrees to participate in the research; A document used to explain the details of a study (clinical trial) that describes the possible benefits and risksRiskChance (likelihood) for an event, reaction or health problem to happen of taking part. It tells you that taking part in the trial is voluntaryVoluntaryTo choose to participate; to do something by choice; to participate because a person wants to; to participate without being forced or made to and that you may leave the trial at any time.

The goal of the informed consent processInformed Consent ProcessThe process of discussing and learning about the details of a study [clinical trial] before deciding whether to participate; a process in which people (participants) are given important information, including possible risks and benefits, about a study (clinical trial) to help them decide if they want to participate in the trial; People are also given any new information that might affect their decision to continue is to protect the participants who enroll in clinical trials. The informed consent process starts when a possible participant first asks for information about a trial and continues until the trial ends.

Though an ICF covers most of the information you need to know to take part, it may not cover some questions about how the clinical trial may affect your everyday life. Visit our What to consider section for a list of questions to ask your trial team.

Screening

Once you have signed the ICF, the trial team will review your medical history, do physical exams, run tests (if needed), and decide if you qualify for the clinical trial. If the trial requires you to pause taking certain medicines, you would need to do so before starting the investigational treatment.

Study participation

What happens during trial participation depends on the type of trial. The trial team will tell you what will happen during participation and will answer any questions you have. You may need to do things such as:

  • Attend phone or in-person doctor visits (these could be days, weeks, or months apart)
  • Write in a diary or eDiary (electronic diary)
  • Fill out surveys
  • Have tests such as blood tests, X-raysX-rayAn image of the inside of the body; pictures (images) of the inside of a person’s body; a test to view and diagnose lung and bone disease, fractures, dislocations, and tumors; a type of imaging study, or others
  • Give samples, such as urine or blood

Follow-up

Once the trial is complete, the trial team may require follow-up phone calls or visits to check on your health and write down any changes that may have happened. The trial team will tell you before you join the trial if you will need to do any follow-up.

Your safety is most important

There’s nothing more important than making sure participants feel safe when taking part in a clinical trial. You can choose to leave a trial at any time, for any reason. It will not affect your medical care.