If you agree to take part in the trial, you will be asked to sign a consent form. This form documents who had the discussion with you about the trial, when and that you agree to take part, knowing you can withdraw at any time.
You should be given a copy of the information sheet and consent form with copies of all the signatures for your reference. You should keep this document so you can be reminded what to do during the study and who to contact if you have any questions.
The next step is to be screened for the study to see if you are eligible to take part. Depending on the trial, the screening period may be minutes, days or weeks. You might be asked questions about your medical history, your family‟s medical history, your current medical conditions, any medications you are taking (which includes any herbal or vitamin supplements, creams or drinks), and/or you might be asked to fill in some questionnaires. Researchers might do some basic medical checks (such as height, weight, blood pressure, pulse rate), collect blood or urine samples, or do more thorough tests like X-rays, MRI’s, CT scans, lung function or exercise tests.
If you aren’t able to continue in the trial, the researcher will discuss with you what your future treatment options are. Some people feel disappointed when they are not suitable for a trial. That is understandable if there are not lots of other treatment options for you, or there is great hope in the new treatment. However, you should take comfort in the fact that the researcher hasn’t let you go in the study because the screening tests suggested the treatment may not have worked for you or it wasn’t going to be safe for you based on the information currently known about the treatment. And remember, a trial of a new treatment is only an investigation of what might work – there is no guarantee the test treatment will work.
If you do continue in the trial, you will get one of the treatments under investigation. Every trial is very different, so the number of visits, what happens at each visit, what you will need to do between visits to the research team and the length of the study will vary. It is very important you follow all the researcher’s instructions during the trial, as these are there to try and keep you safe, and make sure the trial is run properly. A clinical trial is the one time when the rules are NOT meant to be broken.