What is the process of a study?
What are the eligibility requirements to participate in a study?
What kinds of medical problems would keep patients from participating in a study?
Will patients be able to take their usual medications during the study?
Will patients be able to see their own doctor?

What is the “process” of a study?
Patients become familiar with the study by reading the consent form and speaking to one of our research coordinators to answer any questions they may have. Next, a short screening process will be done to determine if they meet minimal criteria for the chosen study.

If the patient meets minimal criteria, a longer screening process is done (usually by phone); the longer screen takes approximately 10 to 15 minutes. If this extended screening is successful, then the patient will be scheduled for their first screening visit.

After their first screening visit, if all study related lab work and diagnostic testing are successful, then the patient will proceed to being an active study “subject." Next, the patient will be assigned a “screen number” and a randomization number. Only their initials, birthdate and assigned numbers are used to identify them on the data we send to the study sponsor.

Patients will be “randomized” in the study, in otherwords, they will be assigned to a specific treatment group described in the consent. Randomization is truly just that, people are placed into “arms” or groups of the study based on a “random” selection that is often computer generated. Lastly, future visits will be scheduled and study materials will be given to them.

What are the eligibility requirements to participate in a study?
The study requirements are different for each study. A research coordinator will review the specific criteria with your patients during the screening process.

What kinds of medical problems would keep patients from participating in a study?
Most IDERC studies require a person to be in relatively good health. Problems that may exclude a person from participation include: acute illness, grossly abnormal labs, pregnancy, steroids, some chronic diseases and substance abuse.  The research coordinators will review your patient's health history during the screening process.

Will patients be able to take their usual medications during the study?
Most of the time, this answer is yes; however, certain medications may not be compatible or preferred while in the study. Patients will be made aware of any changes needed and a substitute medication will be suggested. We will work with primary care providers to make necessary changes if needed.

Will patients be able to see their own doctor?
By all means! We expect and encourage all participants to maintain their relationships with their primary care providers. IDERC will only manage the aspects of their care that pertains to the study protocol. All other related health concerns will be managed by the patient's primary care providers. We are happy to inform all providers of their patient's participation and, with patient permission, share results of lab work, diagnostic testing, etc.