DCI’s Office of Clinical Research was established in 2007 to review all studies (industry or investigator-initiated) being proposed to be conducted in DCI patients to ensure the research is scientifically rigorous and valid and that the appropriate procedures for human protections are being followed. We have expert knowledge in Federal Regulations, HIPAA, Medicare Clinical Trial Policy, Good Clinical Practice, and Federal Wide Assurances.
The Office of Clinical Research now plays a major role in facilitating multisite projects through identifying and confirming participation from the clinics and investigators that are best suited to a particular project, preparing budgets and IRB documents, orchestrating data transfers from the Medical Information System (MIS) and serving as a liaison between study Sponsors, individual investigators/research sites, and the dialysis staff.
We have access to approximately 2500 potential study patients. Our research sites have on average over 12 years of research experience.
DCI has an extensive MIS. All DCI clinics use the system. Information is entered on the patient at initiation to a DCI clinic and updated as events occur (medication changes, hospitalizations). The MIS provides current information about demographics, oral and IV medications, hospitalization dates and the primary diagnosis, and comorbidities. The MIS is problem-based. Problems are created from patient histories, 2728 forms, hospital discharge summaries, and physician correspondence. Problem descriptions come from the ICD-9-CM manual. All orders (medication, treatment, lab, procedures, and consultation) must have an assigned problem in order to enter them into the medical information system. Multi-disciplinary progress notes may also be entered in the MIS. This type of system allows for very extensive precise data collection.
DCI’s Site Management Organization Services
- Teamwork approach between the Sponsor, DCI, the research sites, and the dialysis staff.
- MIS: this robust system allows for a centralized approach to identify research sites as well as eligible patients.
- Dedicated and experienced research staff.
- Template contracts between DCI and research sites to ensure a fast study start up.
- Project Management services to oversee and aid each site with IRB submissions, screening and recruitment, identify and troubleshoot potential problems, as well as provide DCI staff in-services.
- Sites are efficient in recruiting due to the fact they have multiple clinics in a geographical area.
- Dedicated staff to ensure correct invoicing and reconciling of accounts.
- Health Effects of Oral Protein Supplements in Hemodialysis Patients (HELPS-HD) (Jan. 2017)
- Nutritional Vitamin D Supplements do not Help Treat Anemia in Dialysis Patients (Dec. 2015)
For more information regarding the DCI Office of Clinical Research and/or in participating in clinical trials, please contact:
Karen Majchrzak, MS, CCRP
Director of Clinical Research
Dialysis Clinic, Inc
1633 Church Street
Nashville, TN 37203