For anyone participating in a clinical trial, knowledge is both empowering and reassuring. This website provides helpful information to answer your questions before, during and after the clinical trial. 

Informed Consent

As the patient, you are at the heart of any clinical study — your rights and protection are a top priority. We want to make sure all patients fully learn and understand their rights before any trial, so that they can expect their rights to be honored during the trial.

Informed consent

You have the right to understand all aspects of the clinical trial, including any possible risks and benefits of participating. The informed consent process makes sure that the benefits and risks are clear to you. You will be provided with a copy of the informed consent form for reference.

Become familiar with the consent form

If you decide to participate in a trial, you’ll be asked to read and sign the consent form to confirm that the trial has been explained to you, and that you have agreed to participate.

  •  If there are any terms or language in the consent form you don’t understand, ask the trial team as many questions as you need for clarification.
  •  You can take your unsigned consent form home to discuss it with your family, friends, or doctor before making your decision. 

Learn about potential risks

  • The trial team is required to clearly explain all and any potential risks and inconveniences to you, even minor ones.
  •  When applicable, you will also be told about alternative, recognized medical therapies available.
  •  In addition, investigators must make you aware of any information that becomes available during the trial that may be relevant to you.

It’s important that you feel at ease asking members of the research team as many questions as you need, anytime, to feel fully reassured and informed.

You are absolutely entitled to ask questions about:

  •  The consent form, or details of the trial itself at any time
  •  Related procedures or potential expenses
  •  Any adverse reactions that patients experienced in other trials
  •  Any other questions about treatments

You also will have access to direct contact with a trial representative and a person from the Ethics Committee. You should always feel that the trial process is transparent and that the research team is approachable and open to giving you any answers and reassurance you need.

Personal health information from your original medical records and all data resulting from your participation is collected in the trial. Your personal health information could include physical examination details, any blood test results, X-rays, other medical procedures or tissue sample testing. Your identity is always protected through a numbering system; your name and contact details will never be disclosed, unless required by law.

Who sees your data

Information from the trial is submitted to the sponsor , to the U.S. Food and Drug Administration (FDA) and potentially to government agencies in other countries. Your name or contact information will never appear with the medical data and findings. In fact, medical knowledge is gleaned from accumulated findings across many patients, not individuals. Even trial results published in scientific journals are completely anonymous and cannot be linked to individual trial participants.

Your personal information — kept private and confidential — will be held separately in a secure location at all times. The only people with access to your personal health information in identifiable form will be:

  • The trial doctor
  • Personnel helping the trial doctor conduct the study at the facility
  •  Sponsor representatives who check at the study facility that the trial is conducted properly
  •  The Ethics Committee that reviewed the ethical aspects of the trial
  • Local and foreign regulatory authorities where required by law

You have the right to request to see your records from the trial investigator or the facility where the study was conducted. However, you may not be able to review or make a copy of your records until after the study has been completed.

Clinical trial data is highly confidential. Before the study is completed, only selected research staff, sponsor, review board and regulatory individuals are allowed to see the trial data. Sharing data with any other person before completion can compromise the validity of the study in its entirety and jeopardize patient confidentiality and privacy. The trial doctor will let you know what information they can and cannot share with you before the trial is officially over.

Participation in a clinical trial is completely voluntary, so you have the right to withdraw from the clinical trial at any time, for any reason.

If you do stop your participation for any reason, you will continue to receive care and advice on your treatment options. You will be asked to return for a final evaluation by the trial doctor, which may include a physical examination and/or laboratory tests.

When you participate in a clinical trial, your health status is closely monitored by the highly qualified, specialized clinical trial doctors who care for you.

The doctor is responsible for providing you with medical care throughout the study, and ensuring the same level of medical care and follow-up for an appropriate period after the trial, depending on the protocol.

Even if you stop the trial early, the doctor will honor the same trial patient-physician relationship, and continue your care for an adequate period.

However, a clinical trial doctor does not replace the healthcare professionals you see in your day-to-day life.

Ideally, with your permission, clinical trial doctors and your usual healthcare team collaborate to avoid repetition of tests and ensure that you get the best possible care during the trial.

Meet the Stakeholders

Each and every participant in a trial, from the sponsor to you — the patient — has responsibilities to fulfill. Here’s an introduction to the key players and each one’s role and expectations.

A clinical trial simply wouldn’t be possible without the participation of patients. Each patient’s full and diligent participation directly affects the accuracy of the study’s findings, so patients play a key role in a study’s success.

What are a patient’s responsibilities?

Tasks vary depending on the trial, but here are some simple steps that can make the process more rewarding for both you and the team following your progress:

  • Stay on top of your agenda so you can go to your study visits as scheduled
  •  Be honest and accurate when filling out any dosing diaries and/or questionnaires and hand them in as per the trial’s schedule
  •  Keep a notepad handy to track any health problems you are having and share them with study staff, even if they seem trivial
  • Check with your trial doctor first before making any changes to the study medication you are taking
  • Be sure to ask your trial doctor before taking any additional medications or getting vaccinations; the doctor will let you know which medications are allowed while you are participating
The Clinical Center at the National Institutes of Health oversees the conduct of ethical research. 

What is a trial sponsor?

The organization or person(s) that funds, undertakes, and supervises a clinical trial. 

Who can be a sponsor? 

  • A pharmaceutical, biotechnology or medical device company
  •  A university
  •  A healthcare institution such as an academic medical center, hospital or clinic
  •  A voluntary group, private agency or government health agency
  • An individual physician or healthcare provider

What are the sponsor's responsibilities in a clinical trial?

The US Food and Drug Administration (FDA) requires that sponsors of most clinical trials (ie, for trials in phase 1, 2, or 3) submit information documents regarding the objectives, goals and procedures of the clinical trial as well as information to support the quality of the medication. The FDA then reviews the application for approval or denial.

The sponsor also:

  • Obtains approval from the FDA to conduct the clinical trial and complies with regulations before, during and after the trial 
  • Selects qualified physicians (investigators) and hospitals/clinics to conduct the clinical trial 
  • Monitors the clinical trial, making sure the study protocol and Good Clinical Practices are respected and that medical records are complete and accurate 
  • Continuously monitors and evaluates all safety and efficacy information about the study drug 
  • Reports any serious, unexpected or adverse drug reactions to the FDA and investigators 
  • Keeps all stakeholders up to date on the study drug and the progress of the clinical trial and answers any questions as they arise 
  • Analyzes the results and makes them available to all stakeholders once the trial is completed

What is a clinical research coordinator? 

The study coordinator supports the investigator  to meet all their clinical trial responsibilities by handling the day-to-day logistics and reporting of the trial. Often a certified nurse, the study coordinator is also a great resource for the trial participants. 

What are the study coordinator’s responsibilities?

Study coordinators are often involved in the informed consent process and ensuring compliance with the protocol. The coordinator plays a significant role in the trial's success by ensuring that trial visits, tests and procedures are scheduled on time, and that patients understand how to take the study drug and complete the trial questionnaires or diaries. 

The study coordinator’s additional responsibilities include:

  • Preparing various document submissions
  • Identifying patients to be approached for the trial 
  •  Caring for patients, coaching them, and keeping them informed 
  •  Reporting adverse events and sending data to the sponsor throughout the trial

The hands-on leader of a clinical trial at the research site, the investigator — or trial doctor — is in charge of the conduct of the trial in their hospital/clinic, with a specific focus on patient protection and scientific validity of the trial data. 

Who is the principal investigator? 

A doctor who is fully qualified to practice medicine and to run clinical trials. All principal investigators are:

  • Licensed to practice medicine in the area where they live and work 
  • Educated, trained, and experienced in the proper conduct of a clinical trial
  • Familiar with and specialized in the medical field being studied in the trial
  • Familiar and compliant with Good Clinical Practices and other review board regulations 

Clinical trials sometimes take place in multiple locations, even countries; in these cases, each location has its own principal investigator for the research site.

What are the principal investigator's responsibilities?

While the principal investigator is personally responsible for all aspects of the trial, he or she supervises a team of professionals who all contribute to patient safety and compliance with Good Clinical Practices. In particular, the principal investigator: 

  • Makes sure the trial’s objectives, procedures and tests and potential benefits and risks are clearly explained to all clinical trial participants 
  •  Follows the protocol instructions, selects eligible patients and follows randomization and blinding procedures when applicable 
  •  Provides medical care to trial participants, monitors their safety and records all adverse effects during the trial 
  •  Notifies the sponsor and the Ethics Committee of any concerns regarding the safety or efficacy of the study drug

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