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What is a Clinical Trial?

A clinical trial is carefully designed to test the effects of a medication, medical treatment, or device on a group of volunteers. Clinical trials 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.

Our Process

Pharmasite Research. Inc. uses a simple, three-part process for study participants:

1. Phone Screening

The process begins with a confidential phone call with a Recruiter. The Coordinator will discuss the purpose of a study, how long the study will last, what will occur at study visits and the treatments involved. The Coordinator will also ask questions to determine if you may qualify for the study.

2. In-person Screening

If you are found to qualify for a study based on the phone-screening, we will schedule you to be seen for an in-person screening at our office. This visit allows our physicians and staff to directly assess your health status and current symptoms.

3. Enrollment

Based on the results of the assessments at the in-person screening visit, you will be eligible to enroll into the study.

What if I don’t qualify on phone-screening or in-person screening?

Sometimes, a person may not qualify for a specific study due the eligibility criteria for that study. If you do not qualify for a specific study, you will be asked if you wish to be contacted in the future when another study becomes available. If you choose to be included, Pharmasite will contact you again in the future for other appropriate study opportunities.

What About Costs?

There are no costs to study volunteers to participate in a clinical study. All office visits, medical and psychiatric evaluations, lab work, and study medication is provided free of charge.

After Care

Pharmasite Research offers an aftercare program to help study volunteers transition to appropriate care at the end of a study. The Aftercare Program provides study volunteers who appropriately complete a study, up to three follow up visits with a study physician at no additional cost.

If you decide to volunteer to participate in a research study or clinical trial, you have certain rights. At Pharmasite Research, Inc., we believe that personal concern for every study volunteer is vital to the quest for knowledge.

Patient Bill of Rights

As a participant in a research study/clinical trial, you have the right:

  1. To have enough time to decide whether or not to participate and to make that decision without any pressure from the people who are doing the research.
  2. To address any questions you have to the research team and or Principal Investigator at any time.
  3. To refuse to participate in the study/clinical trial, and to stop participating at any time after you begin the study, and to know that your decision will not affect your right to your usual care not related to the research.
  4. To be told why the study/clinical trial is being done, what will happen, and what you will be asked to do if you are in the study.
  5. To be told about any reasonably foreseeable risks, discomforts or side effects that may occur during participation.
  6. To be told whether there are any costs associated with being in the study and whether you will receive any reimbursement for participating in the study.
  7. To be told who will have access to information collected about you, and how your confidentiality will be protected.
  8. To be told whom to contact directly with questions about the research, about research-related injury, and about your rights as a research subject.
  9. To receive a copy of your signed Informed Consent form.

If the study involves treatment or therapy, you have the right:

  1. To be told about the other non-research treatment choices you have.
  2. To be told where treatment is available should you have a research-related injury, and who will pay for research-related treatment.

Glossary

Clinical Investigator or Study Physician
A medical researcher in charge of carrying out a clinical study. Researchers are usually doctors, nurses, pharmacists, or other healthcare professionals.