What to expect in a clinical trial:

Once you have decided to visit the clinic and learn more about the clinical trial that best suits your medical needs you will be asked to read an Informed consent.  At Research Works, you, the patient, are the main focus of any clinical study your rights, protection and safety are our top priority.  Making sure all patients fully learn and understand their rights before any trial is key.

Informed Consent

You have the right to understand all aspects of the clinical trial, including any possible risks and benefits of participating. The informed consent process makes sure that the benefits and risks are clear. You will be provided with a copy of the informed consent form for reference.

If you decide to participate in a 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 Participating 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

Almost every clinical trial will consist of the following visits:

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
• ECG
• 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 is different in each study.

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.

Randomization Visit:  The randomization visit occurs once your eligibility to participate in the clinic trial is verified and your treatment begins. This visit can vary in duration depending on the clinical trial and study medication. Often, you may be asked to take your first dose of study medication in the clinic. You may have tests that are performed prior, during and after your first dose. After your randomization visit, general study visits will occur.

General Study Visits:  At most of these visits your vitals will be taken and the study team will collect information from you about any changes in your medication or general health. It is very important to keep the study team current with all of your health information as it ensures your safety during the clinical trial. If you have made any trips to an urgent care or physician during the time since your last visit, it is very important to tell the study team so that they may request those clinical records.  These visits can be days, weeks or months apart depending on the clinical trial. They will be scheduled by you and your study team.

End of Study Visit:  At this visit, often the same diagnostic testing that was offered at the screening visit will be offered again.  Even when withdrawing early from a study, it is very important to schedule an end of study visit with your study team. The end of study visit establishes the safety and efficacy of the study medicine during your trial participation.