Each clinical research study must follow a carefully constructed protocol specific to that study which has been formatted to reveal in a scientific, objective way whether or not the investigational medication is effective in a statistically significant portion of study subjects.  In most studies, any changes in the health status of the study volunteers, whether obviously related to the investigational medication or not, are documented and followed.  There are many other data points that may be collected at the study visits and documented, such as vital signs, laboratory tests, ECG’s, and other study-specific information.  Research sites, such as Western States Clinical Research, Inc., must conduct each study in strict accordance to its protocol in order to ensure that the data collected from study subjects can be evaluated in the light of a standardized, logical review.  In this way, research sites from across the country and around the world can contribute data that will serve to answer the questions posed by the protocol.  The FDA and regulatory agencies in other countries will then be presented with information that has been as rigorously obtained as possible from which they can make a decision about whether or not to approve the new drug.

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Informed Consent

Research volunteers are asked to read and sign a consent form prior to study enrollment.  The consent form contains information about why the study is being conducted, what a study participant can expect at the various study visits, what the potential risks and benefits may be, and other pertinent information of interest to the potential study volunteer.  Ample time for the volunteer to read and study the consent form and the opportunity to ask questions will be provided by the research site.  The consent form must be presented, read and signed before any study procedures may take place.  The volunteer will receive a copy of the consent form for reference during the study.  

The consent process continues even after the consent form has been signed.  If any new information about the study becomes available, it will be presented to the study volunteer, sometimes in the form of a revised consent form.  A research volunteer may decide to withdraw his/her consent to continue in the study at any time and for any reason.  In this case, the research site will need to know as soon as possible in order to complete the volunteer’s participation in an orderly manner..

The study coordinators and physicians at Western States Clinical Research, Inc. are required to maintain your privacy at all times.  We will not provide personal or medical information to any other parties.  If, after coming into our office and undergoing the informed consent process, you decide to enroll in a clinical research study, then some of your medical information will be used for study purposes, but your identity will remain protected.  

The staff at WSCR, Inc. recognize that the people volunteering as study participants at our research site are the core of our work.  We diligently follow each volunteer through all the initial study qualifications, the study visits and any follow-up that is needed.  The physicians and study coordinators at WSCR, Inc. value the efforts made by research volunteers to participate in clinical trials.  We sincerely try to make our appreciation felt by you, the volunteer, during the entire study process.  

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