Conducting clinical research studies with
SKILL, KNOWLEDGE and SAFETY.
Call to participate
860.443.4567

I Need More Information!

“I need more information.”  This is something we often hear during our initial contact with people who have expressed interest in potentially participating in clinical research trials.  Keep in mind your participation in a trial is voluntary. Sites partner with sponsors, pharmaceutical/biotech companies who are seeking FDA approval on an investigational medicine or an investigational device. Not all studies involve testing investigational medicines. Some studies are observational and do not involve investigational medications. Protocols vary by study, as do the products being tested.  When it comes to research, sites entrusted with running a clinical research trial must do so in accordance with the rules and regulations established by the FDA, and must follow a protocol established by the study sponsor. Think of a protocol as a plan of action.  Each protocol contains inclusion and exclusion criteria for the subjects who enroll. If you meet the inclusion criteria, you can move ahead to screening.  Screening does not necessarily guarantee you will enroll in the study, but starts you on the journey. If you meet the exclusion criteria, you do not move ahead to screening. All of this is typically determined during a telephone conversation where we tell you a little more about the study, and ask you some questions. While our site prefers telephone prescreening, some sites do online prescreening.

If you do come in for a screening visit you will sit down with a study coordinator and go over the informed consent document, or as we sometimes say, “everything you wanted to know, but were afraid to ask” about the study product, study design, potential benefits, potential side effects, etc.  Being well informed you are able to make a determination if this is something you may or may not wish to do.  Research participants are here on a voluntary basis. There is no cost to participate and reimbursement for time and travel may be available for those eligible, but people are here because they want to be here, not because they are compelled to be here. When you request further information, we typically supply you via email (or snail mail) with brochures on the study, a link to the study listing on clinicaltrials.gov and any other relevant information we have at our disposal.

Many who volunteer for research studies do so because they feel they are helping others by being a part of the potential development of new treatments.  If you want to learn more, we’re happy to answer your questions. Call (860)443-4567.