First, you will speak with a Novum associate who will give you some more information about Novum and ask you for some basic information about your health status. If you are eligible to be a participant and you are still interested you will be scheduled for a screening appointment at Novum. At screening we will confirm the information you gave us on the phone and confirm your health status. Before we do this we will ask you to read and sign an informed consent document. This explains the study in detail. You will have the opportunity to ask a member of staff to explain anything you do not understand and to answer any questions. At screening we will ask you for more information about your medical history, perform a physical exam and may do other tests, including taking a blood and urine sample. It is very similar to a standard health checkup that you would have at your physician's office. Your blood sample may be tested for HIV and hepatitis. Your urine may be tested for drugs of abuse and alcohol. After reviewing all of your information a staff member will call you, usually within 48 hours, to confirm that you are eligible for the study and that you are still interested. At that time they again confirm the study dates and requirements with you.
As no two studies are alike, it is important that you check the dates and requirements carefully. Some studies only require you to stay at our facility for two nights on one occasion. Other studies may require longer stays. Some studies may also require you to make short return visits (about 15 minutes) to the clinic in the morning or evening for additional blood draws.
During the study we may ask you to give a number of blood samples. Other studies may also require you to collect urine samples. For studies testing skin products no blood samples are usually required.
The payment that you receive will depend on the amount of time you must spend in the clinic and the number of return visits required. In the past, payments have ranged from $170 to $3,000. Last year, Novum paid 1.4 million dollars to over 2,000 people who participated in a Novum research study. While your are at the facility we will provide you with all of your meals and you will have the opportunity to study, watch TV, view movies, play pool, and take part in other activities. All of these are provided to you for free.
All medication taken at Novum involves some risk. Trained health care professionals medically supervise all studies at Novum and your health is monitored during your participation for adverse effects. For example, we may take your blood pressure and pulse rate at frequent intervals. Adverse effects experienced by people taking the marketed medication will be described to you in the consent form. Before any study is conducted at Novum, it is reviewed and approved by an Institutional Review Board (IRB). This is an independent group of physicians, scientists and members of the public who review the potential risks and benefits to study participation. Only after they have approved the study plan can Novum conduct the study.
In addition, the Food and Drug Administration on a regular basis, inspects our facility and procedures. A representative of the company that is sponsoring the study may also be present at different times during the study. Based on our inspection history and the reports from our study sponsors Novum believes that it follows all of the appropriate regulations and guidelines for the conduct of Good Clinical Practice (GCP).
Please remember that your participation is purely voluntary. You may refuse to take part in the study or you may leave at any time. If you want to leave before a study ends we will ask that you allow us to conduct some tests, including a physical examination to check your health.
The sponsors of the study, the Food and Drug Administration (FDA) and possibly other regulatory agencies may look at your medical records. These records will be used by the study sponsor only as needed to do the research. Your records shall not be used for any other purpose or shown to any third party, except as required by law.