People who participate in clinical trials often describe the process as a journey. You can think of the first on-site screening visit as step two of the journey. In step one, you learned about the clinical trial, asked all your questions, and signed an informed consent form.
Now, you’re ready for the next step. You’ll meet some of the trial staff and go through a screening process that will determine whether you’re eligible to enroll in the trial.
It might be helpful to know a few things about what to expect in that first screening visit.
What Will I be Asked to Do?
The specific requirements of screening vary depending on the nature of the trial. For instance, a trial studying a cancer therapy would likely conduct a CT scan or MRI, while a trial studying a dermatologic therapy may not. However, there are a number of assessments common to most studies.
Meet with the Study Coordinator: You’ll sit down with your main point of contact throughout the trial. They will review your upcoming appointments and what will happen during the screening visit. They may administer questionnaires for you to fill out and review any logs or diaries you may be asked to keep. If you have any additional questions about the trial or screening assessments, you can ask them during this meeting.
Health History and Physical Exam: You will usually be seen by a study investigator (doctor or nurse practitioner) who will take a detailed medical history and perform a physical exam. They will ask about any current or prior health conditions, operations or procedures, and what medications you take. Sometimes you will also be asked to note your current symptoms in what is called a review of systems. These assessments will help determine whether you are eligible to enroll and also establish a baseline of how you are feeling before beginning the study treatment.
Diagnostic or Laboratory Testing: As part of the screening, you may be asked to undergo a series of lab tests, X-rays, CT scans, and other diagnostic evaluations. If you have previously had these tests, you will likely be asked to bring those results with you.
What Should You Prepare?
Sometimes the study coordinator is able to schedule all of the screening assessments in one day and in one place. Other times, the appointments may be spread over two to three days and at more than one location. Make sure you ask how long you should expect to be at each appointment
You may also be asked to bring a family member or primary caregiver, as well as a copy of your health records, a summary of your health issues, your medical procedure history, and the medications that you are currently taking. Of course, bring with you a paper or digital pad so you can record the answers to your questions and take notes.
After you’ve finished the visit, the study team will let you know what comes next for your participation in the trial.
This blog is intended to be informational in nature. The information and other content provided in this blog, or in any linked materials, are not intended and should not be construed as medical advice, nor is the information a substitute for professional medical expertise or treatment.
If you have any questions or concerns, please talk to your doctor. Never disregard professional medical advice or delay in seeking it because of something you have read on this blog or in any linked materials. If you think you may have a medical emergency, call your doctor or emergency services immediately.