Sonora Clinical Research - What to Expect
WHAT IS A CLINICAL STUDY?
A clinical study is carefully designed to test the effects of medication, medical treatment, or a device on a group of volunteers. Clinical studies are an important step in making new medications available. They measure the drug’s ability to treat a condition, its safety and its possible side effects.
HOW IS A DRUG APPROVED FOR TESTING?
The US Food and Drug Administration (FDA) typically must authorize a drug company’s proposal to conduct clinical studies. Drug companies must do years of laboratory research before they can begin testing medicines in humans.
WHAT HAPPENS DURING A RESEARCH STUDY?
What happens during a research study depends on the study itself. Before starting in a research study, you will be asked to sign an Informed Consent Form. Generally, at your first visit the study physician will review with you your medical history and will conduct a brief physical. Additional tests such as blood and urine collection, Electrocardiogram and X-rays may also be done. These are done to check your health prior to participating in the research study. At all visits, you will receive specific instructions for participating in the study and your health will be monitored closely. You may be asked to keep a diary during the study. Study staff will also keep in touch with you after the research study is completed.
WHAT IS INFORMED CONSENT?
Informed Consent is a document and a discussion of procedures, benefits, and risks of a clinical trial between clinical investigators and persons interested in participating in the clinical research study. Informed Consent is a process and takes part throughout the study. Study physicians and staff will continually educate you on the risks and benefits of taking part in the study as well as what you can expect at each visit. The Informed Consent Form highlights all of this information and you will be asked to read and sign this form before your participation in a study can begin. You will be given a copy of the Informed Consent Form for your records and review.
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