The screening process and informed consent

Before joining a clinical trial, you’ll go through screening and informed consent—this page explains what to expect and what to do if you don’t get into the trial.

The screening process

Pre-Screening is the first step to find out if you might be a good fit for a clinical trial. It usually happens by phone, email, or video call. A study coordinator will ask you questions about your health, and you can learn more about the study before going any further.

If the study coordinator thinks you will be a good fit, they will set up a Screening Visit to see if you qualify for the trial. This usually happens in person and includes answering more questions and doing medical tests, like bloodwork, an MRI, or strength tests. A screening visit can take several hours and might feel tiring. Before you do the screening visit, you will go through an informed consent process.

Informed consent

Informed consent is the process of learning all the important details about a study so you can decide if you want to join. This usually happens during the screening visit, but sometimes it’s done by phone or video call.

During informed consent, you will learn about:

  • The purpose of the study
  • What you’ll be asked to do
  • What tests and procedures will happen
  • How often you’ll need to come in for visits
  • The risks and benefits
  • How your data will be used

You will get all this information in a paper or digital document called an Informed Consent Form. If you decide to join the study, you’ll sign this form.

You can change your mind and stop being part of the study at any time, for any reason.

Learn more about informed consent with this video from the Center for Information and Study on Clinical Research Participation (CISCRP).

What questions should I ask?

The pre-screening, informed consent, and screening process is not just for the study team—it’s also for you. This is your chance to ask questions, learn everything you need to know, and decide if the clinical trial is right for you. At the same time, the study team is checking to see if you qualify.

Here are some good questions to ask:

  • How long will the trial last, and what will I need to do?
  • How will the treatment be given?
  • What are the risks and benefits of being in the trial?
  • What happens if I have a bad reaction or side effect?
  • Who makes sure patients are safe during the trial?
  • Will I get medical care during the trial?
  • Should I keep seeing my regular doctor while I’m in the trial?
  • Will I have to pay for anything? Will my insurance cover any of the costs?
  • Will I or my caregiver get money back for travel or childcare costs?
  • Will I be paid for being in the clinical trial?

You can also print and use this helpful guide from Biogen.

What happens if I don’t get into the trial?

Not getting into a clinical trial could feel disappointing, especially if you spent a lot of time doing pre-screening or screening. But it’s pretty common. Depending on the study, sometimes half of the people who go through the screening visit don’t end up qualifying. That’s just part of how clinical trials work.

Sometimes, there are more volunteers than the study needs. If that happens, you might not even be contacted for pre-screening or screening. To help improve your chances, check out our tips on how to improve your chances of getting a call back from a clinical trial.

Even if you don’t qualify for a trial now, you may still be able to get the treatment later—once it’s approved by the FDA, or possibly sooner if the company offers early access.

And there are still lots of ways to help with research! Here are a few: