Published: Sat, March 04, 2017
World | By Tasha Manning

Uterine Fibroid Research Study

Uterine Fibroid Research Study

What is a clinical trial?

A clinical trial, also referred to as a research study, is a scientific study that evaluates the safety and effectiveness of an investigational Medication. A clinical trial may show that the investigational medication is better than, as well as, or better than the standard treatment or inactive placebo. Qualified physicians, nurses and other medical professionals conduct the clinical trial.

It is only through the completion of clinical trials that researches medications can be evaluated, and if proven safe and effective, Food and Drug Administration (FDA).

Who oversees clinical trials?

To help ensure that A clinical trial is ethical and that volunteers' rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve study protocols.

Who can participate in a Clinical trial?

Only volunteers who meet all of the eligibility criteria for a study may participate. The study staff at the research site you select will review your medical history and current medical status against the eligibility criteria. They will determine if you qualify to participate in the study.

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What happens to my personal information? Is private and confidential. With your permission, the information you provide about your medical history and health condition can be transferred to the doctor's office of your choice.

If you pre-qualify for the study, a representative from the doctor's office will contact you to further determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical trial study group without your consent unless disclosure is required by law or regulations of the FDA or similar agencies in other countries.

Scientific presentations of study results will

What kinds of medical examinations are involved?

If you qualify and sign the Informed Consent Form, you will be enrolled in the clinical trial. .

Once enrolled, you will get to the research site for periodic visits to study exams to evaluate your overall health and your symptoms.

Feel free to discuss your study-related medical care with the study physician or staff at any time during the course of the research study. It is important to take all medication study as prescribed and attend all scheduled visits. You will answer questions about how you feel during your participation and whether the investigational medication has been taken at the appropriate times.

How long is the clinical trial?

The study will last approximately 21 months. You will need to make 16-22 visits to the study offices during that time. Can you withdraw from the trial after I have started?

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Your participation in the trial is entirely voluntary and you may withdraw at any time. If you decide to withdraw early from the trial, you will be asked to notify the staff before doing so; You will be asked to return to the research site at least once to complete the final visit and return any unused study medications.

Will I be paid for participation / reimbursed for travel?

Compensation may be provided. The research staff can advise you about this if you pre-qualify and are referred to the research site.

Do I have to pay to participate in the trial?

There is no charge for taking part.

Does my doctor have to give his / her permission?

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