Choosing to participate in a clinical trial is an important personal decision. To assist you we have provided a list of frequently asked question. If you would like more information, please visit the US National Institute of Health site. For further information on clinical Studies, contact us at firstname.lastname@example.org
How do I participate?
Visit in Triumpharma.com and follow the instructions to select a study and submit the information request form. A Triumpharma Health clinical representative will contact you to answer questions and schedule an appointment for a medical exam. Once this is complete, you may be eligible to participate in clinical trials if you meet the criteria for specific studies.
What is Informed consent form?
The first step in the process is for potential participants to agree to participate in a clinical trial. All participants must sign a consent form before they can take part in a trial. This document describes precisely what the study is about, the expected outcomes, and the possible risks of participation. Any questions that participants may have can be discussed fully with our medical staff during that process. Also, if at any time a participant feels uncomfortable or no longer wish to participate in the study, he/she will be permitted to withdraw from the trial as long as the staff is notified prior to departure. This will not result in any penalty for participating in future studies.
How Safety is maintained?
Ensuring the participant’s safety is our number one priority. The teams who administer the trials are composed of highly experienced physicians, registered nurses and qualified technicians, and the procedures they follow are rigorous. The drugs under consideration have already undergone extensive testing in the laboratory and in completely new drugs, in animals.The integrity of the data we will be gathering requires meticulous attention to detail, and rest assured we will provide it.
How confidentiality is maintained?
All records concerning the subjects (case report form, informed consent form and any other documents) will be treated confidentially. No one can have access to these records except for the investigators, sponsor, IRB, insurance company, Jordan Food and Drug Administration or any other regulatory authorities (on request). You will be given a number and an initial to be dealt with throughout the study instead of using your name.
Can volunteers from remote areas participate?
Yes, volunteers from around the world are welcome to participate.
Can I participate in several studies?
Yes, subjects may participate in several studies, but not at the same time. There is a waiting period (usually 80 days) to adhere to between studies to make sure that the drug taken is no longer in your body. This is important to the safety of study participants and assures the integrity of the data obtained during the clinical studies.
Can I leave the premises during a study?
No, it is very important to control the environment for this kind of research, so if the protocol requires, it will be necessary for you to remain at our facility the entire length of the study, although this is rarely more than 48 hours. You’ll be advised of the requirement before you give your consent to participate. This said, participants can withdraw from the study at any time and would then be allowed to leave the premises. In this case, a physician will evaluate the risks of leaving at the time. For safety reasons, we recommend that participants follow the physician’s advice.
What should I bring to stay in the clinic?
Bring all personal care items, like soap, towel, shampoo, clean clothing, books, magazines, laptops, etc. However, depending upon the study, certain personal care items may be set aside to prevent interactions with the drug under study. Bedding is provided but you may bring extra bedding if you wish. Showers are also available for your use.
What type of Meals will be provided?
We will provide all meals during the stay at our facilities. Meals retraction will be added to the subject informed consent form.
What is a clinical trials?
Why You should participate in clinical trials/bioequivalence?
Clinical trials areresearch studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. These studies also may show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce the best data available for health care decision making. Subjects are compensated for their time spent in the clinical center.
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