Frequently Asked Questions

Accordion Content

Eligibility requirements are unique to the particular study and usually include criteria for age, sex, health history and basic lifestyle. Some studies involve people with a particular illness or disease, while others seek healthy volunteers. The FDA seeks to ensure that people from many different groups are included in clinical trials.

At Spaulding Clinical, we hold ourselves to the highest standards. We pride ourselves on providing the best care for our volunteers and ensuring that your stay is both comfortable and safe. Below is a list of amenities available during your stay.

Our state-of-the-art facility amenities include:

• Located just minutes off of Hwy 45
• Situated in a quiet Residential area
• Free Parking
• Executive Chef on staff
• Wireless Internet
• Free Washer and Dryer
• Top Notch Staff

Our spacious volunteer suites include:

• A “privacy curtain” to create your own space in each room
• Private satellite TVs
• Private bathroom with shower
• Two adjustable Thermostats per room

Our unit also contains a large recreation area with various amenities including:

• Big screen TV with DVD player
• Pool Table
• Video Gaming Systems
• Video Game and DVD Library
• Board Games
• Book Library
• Foosball
• Public Computers
• Private Reading Room

It can take between 10-15 years and up to $800 million to develop a new drug. However, this costly and time-consuming process ensures that drugs brought to market are both safe and effective. Spaulding Clinical currently conducts Phase I trials. The clinical testing of experimental drugs is typically conducted within the four phases as outlined below. Each successive phase involves a larger number of subjects. Once the Food and Drug Administration (FDA) has granted a New Drug Approval (NDA), pharmaceutical companies also conduct post marketing or late phase three/phase four studies.

At your screening appointment, you will be tested onsite to determine you eligibility for the study.  Spaulding Clinical staff will review the Informed Consent with you, go over your medical and medication history, perform a physical exam and vital signs, determine your weight, height, and Body Mass Index (BMI), (if female) perform a pregnancy test, screen for drug and alcohol abuse, test your blood and urine, perform an HIV and Hepatitis screen and an ECG procedure.  Since each clinical trial is different, there may be additional tests that could be conducted.  Generally, your screening appointment will last between 3 – 4 hours, unless specified differently.  You will need to bring along a valid and non-expired photo ID, such as a Drivers’ License, Passport, or State ID.  If you do not have a valid or non-expired photo ID, you will not be allowed to screen.  If you have any questions regarding your screening appointment, please contact our Recruitment Department.

If you would like to be put on our email list and get registered in our database, please fill out the short online questionnaire listed under the “Volunteer” tab.  You only need to register once for your database and email list.  When we release a new study, we update the “Available Studies” page on our website.  Volunteers are also always welcome to call our Recruitment Department to see if there are any available clinical trials.  The Recruitment Department can be reached Monday – Friday from 8:00amCST – 5:00pmCST at 1-800-597-4507.  If you are calling outside of business hours, leave a voicemail and our Recruitment Staff will return your call the following business day.

The Food and Drug Administration (FDA) requires that potential participants be given complete information about the clinical trial. This process is known as “Informed Consent” and must be given to the potential participant in writing. Our staff will inform you of any known risks, potential side effects, and potential benefits related to your participation before you begin a study. The Informed Consent process gives you an opportunity to ask any questions and discover what is required of you as a volunteer.  At Spaulding Clinical, the Informed Consent process is unique in the sense that it starts as a one-on-one time that you have with our staff to ask as many questions as you need to in order to understand the clinical trial.  We want to make sure that all of your questions are answered before moving to the next portion of the screening appointment.  The Informed Consent process continues throughout your participation, as any questions that you have will be answered at any time.

If you are interested in a study and meet the basic guidelines provided, contact our Recruitment Department.  Spaulding Clinical Recruitment staff can assist you in determining if a study is a good fit for you by explaining the clinical trial, going over the study length and dates, and asking you several health history questions to see if you qualify to schedule a screening appointment.  All of our studies have different eligibility requirements, so if you do not qualify for one study that does not mean that you will not qualify for a different one in the future.  If you ever have any questions regarding your eligibility, please contact our Recruitment Department.

Simply put, if we do not do clinical trials, we cannot develop new treatments. At Spaulding Clinical, we truly value our volunteer participation, as they are a crucial part of promoting our mission. By volunteering for a clinical trial you can:

• Help evaluate possible new medical treatments and scientific knowledge
• Gain personal satisfaction, knowing that your participation may improve the quality of life for those suffering from chronic disease or illness
• Receive monetary compensation for your participation

You will be completely informed about the requirements and expectations related to a specific study, including any known benefits or risks of study participation through an informed discussion with one of Spaulding’s medical staff consisting of physicians (MD’s), registered nurses and clinical research professionals. Each study is very different, but they all have a screening visit at which time your eligibility will be assessed through interviews, blood draws, physical examinations, etc. If you are chosen to participate in the clinical trial, you will then be confined at the research campus for anywhere from 1 to 45 days, depending upon the study.  Some studies can include Outpatient Visits, which are special separate trips that you need to make to our facility, with the ability of leaving after your visit.  The days of these Outpatient Visits are already chosen ahead of time and the length of these visits will depend on the study.  It is very important to collect study data at set times, in order to understand how a medicine works.  To accomplish this, you will need to attend the Outpatient Visits on the dates/times provided to you during your screening appointment.  For more information on the length of the studies that we currently have, please visit the “Available Studies” portion of our website.

Clinical trial studies are designed to ensure that volunteers are not put at undue risk. Before testing can begin, the study and all study related materials are carefully reviewed by a committee of experts and community representatives called an Institutional Review Board (IRB). As a volunteer, you have the right to refuse treatment at any point in the clinical trial and leave at any time and for any reason. All clinical trials at Spaulding Clinical are done in accordance to Good Clinical Practices and Federal Regulations. Spaulding Clinical is required by law to keep all volunteer records confidential. Only employees of the FDA or other government authorities, the sponsoring company or their representatives, Spaulding Clinical, or the IRB may review volunteer records and information collected during the study.

Generally speaking, upon completion of a study, you may participate in a new one in as little as 30 days. Some protocols may require a rest period of 60 or 90-days, depending on the sponsor’s specific requirements. To find out if you are eligible for a new clinical trial, please contact our Recruitment Department.