Who Is Who on a Cancer Trial Team

Part of Understanding Cancer Trials: The people, your safety, and your rights.

About 4 minutes. Free, in your language, no account needed.

This is general education about clinical research — not medical advice, and not a way to join a study. Talk to your own doctor about your situation.

A lot of people can be involved in a study, and the titles are not always explained. Knowing who does what makes it much easier to know who to ask.

The people you are most likely to meet

The principal investigator. The doctor with overall responsibility for the study at that hospital. In cancer studies this is usually an oncologist. They are responsible for your safety within the study.

Sub-investigators. Other doctors on the team who can carry out study duties. You may see them more often than the principal investigator.

The research nurse or study coordinator. In practice, this is often the person you deal with most. They arrange visits, explain what will happen, take measurements, answer questions, and are usually the first point of contact when something is wrong. Many people find this is the person who knows them best.

Your own oncologist and your usual care team, who may or may not be the same people as the study team. If they are different, it is worth asking how they will communicate with each other.

Pharmacists, radiographers, laboratory staff and phlebotomists, who handle the treatment, the scans, and the samples.

People you may not meet

The sponsor. The organization responsible for the study overall — a company, university, hospital group, or government body. They design the study and pay for it. You will not usually meet them.

The monitor, sometimes called a CRA. Someone who visits the site to check that the study is being run according to the protocol and that the records are accurate. They may look at your records for this purpose. That should be explained to you during consent.

The ethics committee or IRB. The independent group that reviewed and approved the study before it started, and that continues to oversee it. You will not usually meet them, but you can usually contact them, and their contact details should be on your consent documents.

The data monitoring committee. An independent group of experts who look at the accumulating results while the study runs. The next lesson explains what they do.

Who to ask about what

• How a visit works, when something is scheduled, a form, a practical problem — the research nurse or coordinator.
• A symptom, a side effect, anything about your health — the study team's medical contact, following the instructions you were given. Use the emergency number if it is urgent.
• Whether to take part, and what it means for your overall care — your own oncologist.
• A concern about how you are being treated, or something that does not feel right — the principal investigator first. If that is not comfortable or does not resolve it, the ethics committee or the hospital's patient advocacy office.

You are allowed to ask who someone is

If someone comes to see you and you do not know their role, you can ask. You can ask who they work for, and whether they are part of your care team or part of the study team.

That is a normal question, and a reasonable person will answer it plainly.

In short

• The principal investigator is the doctor responsible for the study at your hospital.
• The research nurse or study coordinator is usually your main day-to-day contact.
• Sponsors, monitors, ethics committees and data monitoring committees exist in the background, and you can usually contact the ethics committee directly.
• Match the question to the person: practical to the coordinator, medical to the study medical contact, decisions to your own oncologist, concerns to the investigator or ethics committee.
• Asking someone who they are and who they work for is always reasonable.