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Cetero Research - St. Louis

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FREQUENTLY ASKED QUESTIONS

New Volunteers
 
  • What is a clinical study?
  • What kind of drugs are studied?
  • Are there any side effects?
  • What is a study subject?
  • What are the requirements for a study subject?
  • What does the screening and medical exam entail?
  • How much money do I get paid?
  • When will I get paid?
  • What about taxes on money I make?
  • Can I tour the facility before I do a study?
  • How long do I have to stay?
  • Why do I have to stay?
  • Can I have visitors?
  • How many blood draws?
  • What can I do during a study?
  • How do I sign up?
  • If I sign up, am I obligated?
  •    
    Active Volunteers
     
  • How often can I be in studies?
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    What is a clinical study?
    A study is the basic research program the Food and Drug Administration (FDA) requires before approving a drug for sale in the United States. Gateway's studies usually involve generic equivalents of brand name formulations. There are several kinds of studies, but they involve giving a group of people a dose of the brand-name drug during one study period and a dose of the generic brand during another period. The study begins with the dose, and at carefully timed intervals after the dosing, small blood samples are taken for analysis to establish whether the generic drug delivers its active ingredient to the body in the same time frame, and amount of drug, as the brand-name (marketed) drug.

     

    What kinds of drugs are studied?
    Clinical studies at Gateway typically involve generic versions of currently approved brand name drugs. Some drugs are prescriptions and others are over the counter drugs. We have tested generic versus brand name products used for low iron, pain, high blood pressure, ulcers, etc.

     

    Are there any side effects?
    We see very few side effects. However, every medication, including vitamins has a list of known potential side effects. The most commonly occurring side effects will be listed in the consent form. If you choose to participate in a study, you will know beforehand the drug involved. We have registered nurses, physicians, and a pharmacist on staff to answer any questions you may have about side effects. An E.M.T. and/or paramedic is on duty at all times during your stay at the clinic.

     

    What is a study subject?
    A study subject is a healthy 18 years, or older adult who is paid to participate in our clinical research studies.

     

    What are the requirements for a study subject?
    The majority of our studies require healthy adults who:

  • are at least 18 years old
  • are on no medications or taking any drugs
  • have no history of serious illness

     

    What does the screening and medical exam entail?
    There is a medical screening and a physical exam required before participation in a study. The medical screening includes an EKG, urinalysis, complete blood count, blood chemistries, test for HIV and drug screen. The physical exam is performed by one of Gateway's licensed physicians. These exams are paid for by Gateway.

     

    How much money do I get paid?
    Studies typically pay from $400 to over $1,000, depending on the length of stay at the clinic.

     

    When will I get paid?
    Subjects are paid three (3) business days after completion of studies.
    (Back-ups are paid two (2) business days after release from studies.)

     

    What about taxes on money I make?
    We do not deduct taxes from your check. You will receive a 1099 form from Gateway. You may be obliged to pay self-employment tax (@ 14%) and Federal and State income tax (as required). We suggest that you save a portion of this money to satisfy your tax obligation and contact your tax consultant for more specific advice.

     

    Can I tour the facility before I do a study?
    You are welcome to tour the facility. In fact, we suggest this to our study subjects so that you can see where you will be staying. Please call our Recruiting dept. at 636-946-2110 to schedule an appointment.

     

    How long do I have to stay?
    Studies usually consist of at least two periods. Each period begins with checking in to the clinic around 7PM the evening before the dose. Subjects usually remain at least 24 hours after their dose the next morning.

     

    Why do I have to stay?
    You are required to stay at Gateway's facility in St Charles, Mo. for the duration of each study period so you can be monitored, and your diet and activities can be controlled. We are studying how the generic versus name-brand drugs are metabolized, and that can be affected by what you do and what you eat.

     

    Can I have visitors?
    Yes, during approved visiting hours. The visiting hours vary with the study, but typically last from 12 noon to 10PM. There is usually a two hour time limit for each visit. Visitors aren't allowed on check-in nights.

     

    How many blood draws?
    The number of blood draws varies with each study. It can be anywhere from 10 to 20 samples each study period. The total amount is usually equal to or less than what you would give at a blood donation visit.

     

    What can I do during a study?
    There are different recreational activities in each study area. Some areas include TVs DVD players, pool table, public phones, books, and magazines. You are welcome to bring in your own books, magazines, cellular phones, pagers, computers, TVs, etc. We are not responsible for those items that you bring in.

     

    How do I sign up?
    You can sign up by calling our recruit lines at (636) 946-2110 and a recruiter will get back to you.

     

    If I sign up, am I obligated?
    Filling out an application does not obligate you to participate in a study. If you do sign up for a particular study, we ask that you make a strong commitment to be present for all required study dates. (We understand that there will be instances of family emergencies, etc.)

     

    Active Volunteers

    How often can I be in studies?
    After you complete a study, you will be eligible after at least a 30 day waiting period.

     

     


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