Find more information about what to expect when participating in a Phase I study.
What to Expect FAQ
How long do studies last?
It varies. Some studies involve only a weekend or two in the clinic, while other studies require longer confinement periods of up to several weeks. Post-study follow-up visits called outpatient visits for blood samples are sometimes necessary.
What are the risks?
We refer each study protocol to an Institutional Review Board (IRB) composed of members of the public, including medical professionals, who are independent of the clinic and PPD. The IRB evaluates each study protocol to determine if it complies with international regulatory guidelines to ensure volunteer safety and well-being.
The IRB is there to protect your rights, safety and well-being. The board reviews and approves all aspects of each study, including the type and dose of medicine that will be given to you, all of the measurements that will be conducted throughout the study and the payment you will receive.
The doses of medicine that volunteers are given are very carefully controlled. Sometimes there may be side effects. All known side effects will be explained to you before you decide whether or not to take part in the study for which you qualify. These side effects are generally mild and could possibly include headaches and sickness. For your own safety, it is essential that you always tell us about all prescription and nonprescription medicines and dietary supplements that you are taking.
Are there any rules when I am at the clinic?
Yes, we provide you a list of house rules for the safety and comfort of all volunteers. These include rules on smoking, alcohol and caffeine use, as well as behavior. In addition, an individual sponsor may have rules that relate to a specific study. For example, you may be required to eat all the food provided or to refrain from physical exercise.
What do I need to bring with me when I am in a study?
You need to bring all toiletries, towels and sufficient clothes for the duration of your stay. Do not bring in any food, drink or cigarettes if it is a non-smoking study.
Are volunteers allowed to bring cell phones with them when they are participating in a study?
Cell phones are allowed, however if the phone has a camera, it must either be removed or covered with tamper-proof tape provided by PPD. No cameras of any type are allowed in the clinic. Cell phones must be turned off during study procedures. There are courtesy phones available for volunteers to use for local calls.
Is there a medically qualified person in case of an emergency?
Yes. The health and well-being of every volunteer are our priority. Qualified medical staff are always available and a doctor is on call at all times.
Study Process FAQ
Do I have to be ill or in pain to test the medicines?
No, we are not testing to see if the medicine works or not. These studies are to find out how the medicine acts in the bodies of healthy volunteers: how the compound is absorbed, distributed, metabolized and excreted.
Do I have to have a test for HIV?
An HIV test is required for some studies. You will be informed in the screening process as to whether or not you will need to be tested for HIV.
What happens if I don't want to continue at any point during the study?
You can withdraw from a study at any stage.
How do I sign up for a study?
You can sign up by calling 1-800-773-2782. A phone recruiter will ask you questions about your present health and medical history, and will schedule your screening appointment if you qualify for the study you have selected.
What happens if you find something wrong with me at the screening visit?
At the screening visit, we may do tests that you may not normally have had done in a routine medical checkup. For example, tests may include a heart trace (electrocardiogram) or blood tests which measure the health of your liver. If we suspect something is not quite right, we will do a repeat test to check the results. If we do detect a potential health concern, our doctor will inform you so that you can take the appropriate action.
Can I do more than one study?
Yes, many of our volunteers qualify for different studies and work with us a number of times. However, you cannot participate in more than one study at a time, and there is a minimum waiting period between studies. This waiting period is known as the “wash-out” period and varies between one and four months, depending on the medicine that was tested. Also, if you are a blood donor, you will need to meet a minimum “wash-out”" for blood donation, which will vary from study to study.
I am on Social Security benefits. Will they be taken away?
You are advised to declare payments made to you when you complete a study. The clinic is required by law to provide information to the IRS about payments to volunteers enrolled in studies.
Where is the clinic located?
The clinic is located at 7551 Metro Center Drive, Suite 200, Austin, Texas 78744.
Directions (via Google Maps)