Who can participate?

Anyone can take part in a clinical trial. They can also stop participating in the trial whenever they choose.

But first, you must be eligibility before you can participate.

Meeting eligibility is vital for your safety. It also makes sure the clinical trial is effectively treating the disease.

If you are interested in being part of a clinical trial and you meet the essential criteria, (appropriate age, disease type, etc.), then your doctor will give you a Participant Information Consent Form (PICF) form to fill out.

Before starting the trial

• The PICF will tell you everything you need to know about the clinical trial you are in.
• A member of your research team at Grampians Health (the investigator or clinical trial coordinator) will give you a copy of the PICF. You will be given enough time to read it through, talk to your friends and family, and think of any questions you may have for your study doctor.
• You will then have a thorough conversation with your doctor and have time to ask any questions you may have.
• If all your answers have been answered and you still want to join, you will sign the PICF with your doctor. You will be given a copy of the signed PICF for your records.
• It is important to remember that this PICF is not a contract. You can withdraw your consent to participate at any time.
• Now that you have signed the PICF, you have given your research team permission to start screening you for the trial. Screening involves your research team organising any tests needed by the trial. These extra tests may include blood tests and imaging scans (like an x-ray, CT or MRI). Once these tests have been completed, your doctor will review your results and confirm whether you meet the eligibility criteria. After this, you will begin treatment.

During the trial

• While in the trial, there are some extra tests that you will need to complete compared to someone who is not in a trial. This is because everything is closely monitored while in a trial.
• You may have to complete questionnaires asking you about your emotional and physical health.
• Because there are additional tests and paperwork, you have a study coordinator to help you. You can call your study coordinator if you have any questions or concerns, and they can help with making appointments with the doctor if needed.
• You will still be able to use services at Grampians Health, such as dietetics and nutrition, exercise physiology, psychology and social work, if you need. Ask your doctor about what is available to you.