Every clinical study has its own research team...
It's made up of doctors, nurses, research coordinators and scientists, pharmacists, and developmental specialists, to name a few.
The most important members? Children and their parents.
The medical and research teams make sure that your child is eligible to join a study, give instructions and monitor your child during the study. Not just anyone who is a nurse or doctor can be on the research team. In addition to their medical training they must take special classes and are highly trained in how to protect participants and conduct studies in an ethical, legal and safe way.
They are prepared to answer any and all of your questions...and always respect the parent's role as the one who knows your child best.Dr. Gail Pearson, Pediatric Cardiologist
The Principal Investigator (PI) is often a medical doctor and is responsible for the entire study. He or she oversees the care of all the participants while they are in the study. The PI can sometimes be your child's regular doctor.
The Research Nurse(s) are responsible for patient recruitment. They also assess eligibility and, along with the study doctor, provide treatment. Part of their role is to collect data, and follow up with participants.
The Research Coordinator(s) make sure the study runs smoothly. They understand all parts of the study and make sure the staff has the right equipment, medication or devices needed to run the study.
Parents should be comfortable and familiar with the study team. Know who to call for general questions, and who to call in an emergency.
What happens if you run out of study drug? Who do you contact about side effects? What if it is 2 AM?Jackie, mother of child in Fabry disease study
Nicole, mother of child in heart defect study
Victoria Pemberton, RN, Research Nurse
Institutional Review Board: A group of experts who monitor clinical studies to make sure people are safe.
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