During a clinical study, you’ll receive the medication that is being studied. This will be done at scheduled times and may occur only once or multiple times throughout the study, depending on the medication. If you participate, you may also have the following procedures performed to monitor your health: vital signs, blood work, physical exams or other types of assessments that are necessary to gather the required information about the study medication. In some studies, you may not receive the study medication, but instead receive a placebo (a substance having no pharmacological effect but administered as a control). All study volunteers are closely monitored by our clinic staff and medical team to ensure their safety at all times.
Each clinical study has requirements for participants based on specific factors such as age, medical history and current health. The eligibility criteria in each study protocol are used to identify the volunteers best qualified to participate.
PRA conducts clinical studies in all four of our clinical research centers across the United States – addresses can be found here. For in-house studies, volunteers stay in the clinic during the study and may not be allowed to leave the premises due to safety reasons. Out-patient trials do not require any overnight stays.
Most clinical trials may involve some risk. Side effects are possible when taking medication, however, the safety and well-being of participants is always our number one priority at PRA. PRA has been successfully conducting trials for more than 20 years and has an excellent safety record. Read more about Safety & Privacy here.
Participating in a clinical study is a great way to help with the development of new and improved medications. As a study participant, you may be eligible to earn reimbursement for your participation and time.
You have the right to ask any questions before, during or after volunteering. Some questions may include: What is the intended use of the drug? What are the risks? What are the benefits? What will I need to do? How long does the study last?
An Informed Consent is a process that explains the details of the study, including the potential risks and benefits, as well as your rights and responsibilities. You will be provided the facts about the study to help you determine if you want to participate in the study. This includes details and possible side effects of taking the investigational product (medication).
Every clinical trial in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits to the volunteer. As a volunteer, you have the right to discontinue your participation and leave the study at any time and for any reason, with no penalty or loss of benefits to which you are otherwise entitled to.
While participation in a clinical study is voluntary, you may be reimbursed for your time and travel. Compensation is based on the length of the study, the number of overnight stays, the number of out-patient visits you attend, and also based on risk. You may also be compensated for specific procedures depending upon the study. All payments we make for study participation have been approved by an Independent Review Board (IRB). The method and frequency of payment will be described in detail in the Informed Consent Form (ICF).
Once you submit the form, you’ll be contacted by a volunteer recruiter from the PRA Recruiting Department. The recruiter will discuss available studies and ask you a few more questions to make sure you meet the eligibility requirements of the study. If you do, the next step will be to schedule a screening appointment.
You are provided with detailed information about the study and can decide at any time if you wish to continue to participate. Several tests may be performed such as vital signs, physical exam, blood work, questionnaires, or others to determine whether you qualify for the study. If your information and results match the requirements for the study, you may be given the option to participate.