What to expect in a clinical trial:
- If you decide to participate in any clinical trial, you’ll be asked to read and sign the consent form to confirm that you understand what the trial is about and that you have willingly agreed to participate.
- If there is ever any question or something you don’t understand ask the trial team as many questions as you need. If you need to speak with a Physician to help you understand the consent form or anything about the trial you will be scheduled at a time when the study Doctor can answer your questions.
- You may always take your unsigned consent form home to discuss it with your family, friends, or doctor before making a decision.
- As additional information is made available that may be relevant to your clinical trial participation, you may be asked to sign another consent that will make this information clear to you.
Your Rights In a Clinical Trial:
- You have the right to ask questions and get answers at any time.
- You have the right to know what other treatment options may be available to you.
- You have the right to confidentiality and privacy-Your personal information is kept confidential and secure at all times.
- Your personal identifiers will be removed from study documents.
- You have the right to access your data.
- You have the right to withdraw from a clinical trial at any time.
- You have the right to the very best care.
During the trial:
Screening Visit: The screening visit often occurs during one visit to the clinic but can last for a certain window of time that gives the study team enough time to assess your eligibility for participation. This visit will often include the following assessments that will be offered to you at no cost:
- Comprehensive Blood Work
- Physical Exam
- Vital Signs
Complete Medical History which could include requesting your medical records from your primary health care provider. It is important to tell the study team about any conditions with which you have been diagnosed by a Physician and about any and all medications that you regularly take. Being very thorough and clear with your study team will ensure your safety.
Study specific Diagnostic testing which will be offered at no cost varies in each clinical trial and could include mammograms, pap smears, biopsies, endoscopies, ultrasounds, DEXA scans, MRI’s
You should familiarize yourself with the diagnostic tests that will be offered to you during the trial and ask the study team where and when these tests will be scheduled. Once your eligibility is determined, your study team will schedule what is called a Randomization visit.
General Study Visits:
End of Study Visit:
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