Clinical Research

We have many studies that we are currently performing in several therapeutic areas including Cardiology, Cardiac Diagnostics, Oncology, and Urology. We hope to be able to expand to other specialties as our department grows. We will soon be listing active studies on this site, so please return for updates.

If you are interested in participating in a clinical trial at Central Utah Clinic feel free to contact us at: 801-354-8228

Study Volunteer Bill of Rights

Any individual who elects to participate in a clinical trial at Central Utah Clinic has the following rights:

1. The right to be allowed to ask any questions about the clinical trial before giving consent, as well as during participation in the trial.
2. The right to be given ample time, without pressure from the staff of Central Utah Clinic, before signing the informed consent form.
3. The right to receive a copy of the signed and dated informed consent form.
4. The right to be told the reason for the clinical trial.
5. The right to be told the known benefits that can reasonably be expected during participation in the clinical trial.
6. The right to be told what kinds of medical tests will be done and when.
7. The right to be told of alternate treatment options if available, and the risks and benefits of each option.
8. The right to be told the known side effects or discomforts that might reasonably be expected during participation in the clinical trial.
9. The right to be told of any medical treatments available if the patient experiences a complication from participation in the clinical trial.
10. The right to be told who will be responsible for paying the cost of the medical treatments if any complications occur during participation in a clinical trial.
11. The right to refuse to participate for any reason, before and during the clinical trial.
12. The right to be told of any information learned during the clinical trial that might influence the patient’s decision to continue his/her participation in the clinical trial.

Should you have any questions regarding your rights as a volunteer please feel free to contact the research staff at 801-354-8228 in order to discuss these questions.

Useful Links

www.nih.gov/health/clinicaltrials/

Why Participate in a Clinical Study?

• Clinical trials make the practice of medicine more interesting. Physicians can take a fresh look at routine procedures and prescribing habits.
• Clinical research can enhance the physician’s reputation and/or ranking.
• Help to bring a potentially "breakthrough" product to the market that may affect thousands of lives.
• Opportunity to enroll or refer a patient, who has run out of treatment options, into a trial, which may improve his or her life.
• As reimbursements for services go down from insurance companies, participation in clinical studies can add additional revenue sources to physicians and clinics.

Purpose of Clinical Research Department

Competition in research is getting stronger as federal regulations become more stringent and pharmaceutical companies seek reliable and efficient clinical research sites, limiting the amount of investigators they will choose to work with.

Physicians doing studies through the research department will have the benefit of a qualified research staff that includes study coordinators and administrative support. This allows you to focus on the protocol and patient care and let us manage the regulatory requirements of performing a clinical trial.

Services Provided

Once the physician has decided to participate in a study the research department would be responsible to provide the services listed below, consulting with the physician when needed.

• Liaison between study sponsor, FDA and IRB and physician(s)
• Review study protocols with Primary Investigator and staff
• Prepare 1572 form, CVs and resumes of those involved in the function of the clinical trials
• Preparation of documents: Informed consent; IRB documents; study correspondence; tracking logs; signature logs, delegation of authority forms, adverse event forms, case report forms
• Cost determination for required visits, labs, diagnostic tests
• Review protocol for study profitability
• Contract negotiation, payment schedules and budget or protocol amendments when needed
• Preparation for initiation visit, site visits, pharmaceutical and/or FDA audits, monitor visits and close-out visits
• Prepare study packet for enrolled subjects: Orders, lab requisitions, study visits with Primary investigator
• In-service participating staff to study protocols, supplies, adverse events
• Preparing the research chart
• Screen patients for possible study participation: past medical history, past treatment history, baseline assessment and labs, and base line signs and symptoms
• Screening visits
• Handling payment to study participants
• Document storage/disposal
• Tracking data
• Follow-up on any missing or unknown data, data corrections
• Tracking and notification for all adverse events
• Facilitate the reporting of serious adverse events to appropriate local committees and Federal agencies
• Pulling and preparing the data for queries, audits or protocol violations
• Drug storage and when necessary drug disposal
• Generation of randomization codes for subjects
• Pharmacokinetic sampling and shipping PK samples
• Write integrated clinical study report
• End of study follow-up
• Submit study documentation Physicians wanting to be more involved in research, and want to be more hands on, may choose to contract for certain tasks to be done by the research staff while he or she is responsible for performing the remaining tasks. Advantages of Clinical Research Department
• Proactive in obtaining study protocols
• Study Manager Software used to closely manage study operations and financials
• Full HIPAA compliance
• Clinic resources that are appealing to sponsors
• Contract negotiations and budget management
• Trained staff to assist you in the entire process from start-up to close-out

Medical Director
Scott Bingham, MD

Administrators
Lee Gallagher
Ben Hodges

Clinical Research Coordinators
Mary Antonino, MA
Jantzen Menlove, CMA