Daily movement has lots of health benefits and is an important part of maintaining physical and mental health for most people. When preparing for your appointment, however, please try to avoid doing unusually strenuous activities for about 2-5 days prior, as this can impact measures of liver and muscle enzymes in your blood. This includes things like shoveling snow, helping a friend move, weight lifting, starting to train for a marathon, or any other activity that is not a typical movement for you. Generally speaking, if you are an athlete or frequent the gym, you should be able to do your typical exercise if you stay within your normal range of difficulty (ie. do not go for a new personal record but focus on form, etc.) or you can choose to take a rest day.
At the PCRU, we want you to get the most out of your visit, whether this is your first study or your 10th. Many of your daily activities can have a big impact on measures of your health and may determine whether or not you ultimately qualify.
This guide is intended to help you understand your health habits and how they relate to study criteria, as well as give concrete suggestions to prepare for a study visit or to just maintain your overall well-being. If you have questions that are not answered here, please feel free to contact our staff and we’d be happy to help you.
Jump to:
Consent | Hydration | Nutrition | Exercise | Stress | Substances | Visit Day | After Screening
Getting started
If you’re thinking about or already made the decision to sign up for a trial at the PCRU, we’re here to answer questions and help you prepare for your participation. The first step in the process is to complete a phone-screen questionnaire, where we’ll review your overall status and medical history as well as ask some specific questions based on the study you’re interested in. Next, you’ll be able to schedule an in-person screening appointment which may include a physical exam and some laboratory tests such as blood and urine tests. Finally, prior to actually dosing on any study, you’ll repeat some of these assessments at the point of check-in or admission just in case anything has changed.
All of these tests and questions are to help determine if you are eligible for the study you are interested in. Assessing eligibility is one of the most important parts of the enrollment process and makes sure that participating in a specific trial is a safe option for you.
Before your visit
Consent
Informed consent is the foundation of all clinical trial procedures. The informed consent document (ICD) contains all of the information about a specific trial that is important for a participant to understand prior to agreeing to be in the study. You can review the ICD prior to your appointment by requesting it from the recruitment team when you call to schedule your appointment. Reviewing this document ahead of time can help you to prepare questions and be more informed about what to expect.
Hydration
Hydration
Drinking enough water is not only vital to good health but is highly important for your pre-study labs. You should aim to drink between 6.5-8.5 cups of pure water every day (for at least few days prior to any appointment) and spread this amount out across the whole day.
Try to avoid drinking a large amount of water right before your visit to compensate for not drinking enough on other days, as this can dilute your urine and actually make it harder to assess your eligibility and health status.
Nutrition
Balanced nutrition is always discussed when talking about health, but this will look different for each person. For life as well as your labs, the name of the game here is moderation – unless specified by the study staff, you don’t need to cut out certain foods or only eat certain other ones. Instead, for a few days prior to your appointment, try to eat a balance of carbohydrates, protein, and fats from a variety of sources including fruits, vegetables, and whole grains whenever possible. Try not to have an excess amount of added sugars and saturated fats as these can affect liver and blood sugar tests – even too much protein can affect the labs that measure kidney function, so stick to your usual daily amount and avoid supplementing with powders. You can refer to the American Heart Association's guide on clean eating for some helpful suggestions and to debunk some common food myths.
If the study you are interested in does have food restrictions, this will be discussed with you prior to your appointment with formal guidelines for how long before or after your visit.
Exercise
Exercise
Stress
Unsurprisingly, high levels of stress can impact your physical health, altering things like blood pressure and blood sugar. Whenever possible, try to avoid high-stress activities and get sufficient sleep (about 7-9 hours), especially in the days leading up to your study visit. When it’s unavoidable, you can try one of these stress relief techniques from the American Heart Association, or look for meditation and stress relief videos or apps online to help manage your stress symptoms.
Alcohol, medication, or other substances
Alcohol, medication, or other substances
Supplements, alcohol, caffeine, over-the-counter (OTC) medications, and other substances are a normal part of daily life for many people. Please make sure to let your study staff know about anything that you have taken or plan to take in the time leading up to or after a study visit. Many substances or medications can interact in unforeseen ways with study drugs in a clinical trial. For your safety, we may restrict the use of supplements, medications, alcohol, caffeine, nicotine, and recreational drugs while on study and for a window of time prior to screening or dosing. Our staff will discuss this with you during your pre-screening phone call based on the requirements of the specific study.
Please note that we perform urine drug screening for all participants on all studies. Your results are always maintained with confidentiality, but a positive result may impact your ability to participate in current and future studies. Because of this, please be honest about any recent use when asked during phone-screening and allow us to schedule or reschedule your visit accordingly. Please also be aware that some common foods or OTC medications can cause a false positive result, such as poppy seeds or hemp products, so please try to avoid ingesting these prior to your visit.
On the Day of Your Appointment
If it is your first screening for a study, please make sure you bring your social security card and a photo ID such as a state license or driver’s license, even if you’ve done other studies with us in the past. These ensure that we can issue your study payments and verifies your identity for the study.
For all study visits, please make sure you do not bring any restricted items to the PCRU. This includes things like medications, weapons of any kind, valuables, or large items like suitcases (unless you’re here for study admission). Upon arrival you may be searched or scanned with a metal detector. Please also do not bring pets or children with you or leave them in your car without attendance.
We also understand that life happens and you may need to move your appointment. If you need to cancel or reschedule, please give us a call at any time before the time of your scheduled appointment. If we are not available, you can leave a voicemail, or you can email us as well. Not showing up for visits or showing up late without letting us know can affect your eligibility for future studies at our unit.
After your visit
Your study recruiter or coordinator should be in touch with you within a few days of your screening visit to explain your results and walk you through the next part of the process, which in most cases includes staying at the PCRU for a few nights.
Curious about the in-house portion of your study? Watch the video below to follow a participant through a typical inpatient experience and learn more about what to expect while you’re here. If you are looking for information on our outpatient vaccine clinic, please click here.
