Clinical trial pre-screening is a short set of questions used to check whether you may meet a study's basic eligibility criteria before moving to formal screening. It usually takes around five to fifteen minutes and may be completed online or over the phone.
Pre-screening doesn't enrol you in a clinical trial, isn't a medical assessment and doesn't mean you're definitely eligible. It's an early check designed to help you and the research team understand whether the study could be a potential fit.
What is clinical trial pre-screening and what isn't it?
Pre-screening is an initial eligibility check. It is:
- Not informed consent. If you progress, you'll receive more information about the study and have an opportunity to ask questions before deciding whether to participate.
- Not a medical assessment. Pre-screening doesn't provide a diagnosis or medical advice.
- Not a commitment. Completing the questions doesn't mean you have agreed to join the study.
- Not a test you pass or fail. Every trial has different eligibility criteria. Not qualifying for one doesn't mean you won't qualify for another.
Why are there so many pre-screening questions?
Every clinical trial has specific eligibility criteria set out in its study protocol. These criteria help protect participants and ensure researchers are studying the appropriate group of people.
You may be asked about your age, diagnosis, medications, other health conditions, previous treatments, recent test results or whether you've recently participated in another study.
Some questions can feel quite detailed, but they're usually there for a reason. Certain medications or health conditions, for example, may affect your safety or the study results.
Asking these questions early can also save you time. If there's a clear reason the study isn't suitable, it's generally better to find out before arranging a screening visit or completing further assessments.
What happens to my information during pre-screening?
Pre-screening can involve sharing personal and health information, so you should be told how your information will be collected, used, stored and shared.
In Australia, organisations handling personal information may have obligations under privacy legislation, including the Privacy Act 1988 and Australian Privacy Principles where they apply.
Your information may be used to assess your potential eligibility and, where appropriate, shared with the research team or study site so they can contact you about the next steps.
What happens after clinical trial pre-screening?
If you may be eligible: the research team or study site may contact you to discuss the study, ask further questions and potentially arrange a formal screening visit.
At this stage, you'll receive more information about what participation involves and have the opportunity to ask questions before deciding whether you want to continue.
It's important to know that passing pre-screening doesn't guarantee you'll be able to join the trial. Your eligibility will need to be confirmed through the study's formal screening process.
If you don't appear to be eligible: you may be told that the study isn't suitable for you based on your answers.
Being ineligible for one clinical trial doesn't mean you're unsuitable for clinical research. Every study has different requirements, and you may be eligible for another trial.
What should I have ready for pre-screening?
Having a few things nearby can make the process easier:
- A list of your medications, including prescription medicines, over-the-counter medicines and supplements.
- Information about your diagnosis, including roughly when you were diagnosed and any relevant recent tests.
- Details of previous treatments you've tried for the condition being studied.
- Your GP or specialist details, if they're requested.
Don't worry if you don't know every answer. Give the most accurate information you can and let the research team know if you're unsure.
Common questions about clinical trial pre-screening
Do I need my doctor's permission to pre-screen?
Generally, no. You can usually express interest and complete initial pre-screening yourself. If you progress, the research team will explain whether information from your GP or specialist is required.
How long does pre-screening take?
It depends on the study, but many initial pre-screening questionnaires can be completed in around five to fifteen minutes.
Does passing pre-screening mean I'm eligible?
No. Pre-screening only determines whether you may be eligible. Formal screening is used to confirm whether you meet the study's full eligibility requirements.
Can I change my mind after pre-screening?
Yes. Completing pre-screening doesn't commit you to participating. If you progress, you can learn more about the study before deciding whether you want to continue.
Ready to pre-screen for a clinical trial?
Pre-screening is simply the first step in finding out whether a clinical trial could be an option for you.
Have your medication and health information nearby, answer the questions as accurately as you can and don't worry if you're unsure about something. If you appear to be eligible, you'll have the opportunity to learn more about the study before deciding whether taking part is right for you.