About TGH Clinical Research
The Tampa General Hospital Office of Clinical Research enhances biomedical discovery by facilitating industry sponsored and principal investigator initiated clinical and health service delivery research in conjunction with the University of South Florida and other academic partners, community physicians and industry. The TGH Office of Clinical Research provides administrative infrastructure and resources to support the research efforts of TGH’s physicians, nurses, pharmacists and scientists.
In support of Tampa General Hospital’s vision of being at the forefront of medical research, the TGH Office of Clinical Research will become the cornerstone of an integrated and collaborative culture of discovery. The Office of Clinical Research will be a vital and self sustaining resource to all investigators conducting clinical research. The Office of Clinical Research will enhance research capacity at TGH through training, financial administration, exploitation of technology and oversight of studies.
The OCR recognizes that the process of developing, implementing and publishing a clinical trial can be time consuming and cumbersome, especially for physicians who already extend themselves everyday in clinical practice. The OCR staff is comprised of employees that specialize in different areas of the clinical research process to assist in the facilitation of each research project from grant writing and study development to TGH/IRB application, trial implementation, and data analysis. Whether a study is investigator initiated with little resources or a sponsored project in search of adding a site, OCR can provide different levels of support to meet the needs of each study individually.
The Office of Clinical Research currently employs staff with expertise in:
- Protocol Design and Implementation
- Financial Management
- Regulatory Documentation
- Research Compliance
- Investigational Pharmaceuticals
Among the many services offered by OCR are:
- Budgeting—both sponsor and hospital budgets
- Contract Review—indemnification, subject injury, reimbursement
- Financial Management—billing, collections, research fee schedule maintenance, protocol assessment, sponsor negotiation, receivables management
- Protocol Implementation—evaluation of resources required, forms guidance, interdepartmental facilitation
- Investigator Assistance—medical writing, biostatistics, education and inservicing
- Biostatistical Services—protocol design, sample size calculation, statistical analysis plan, data analysis
In addition to the OCR administrative services, the TGH Center of Research Excellence (CORE) provides:
- Pre-study services include study placement, coordination of pre-study site visit, regulatory work, lab and radiology research pricing, and arrangements for special services.
- Study coordination services beginning with the site initiation and ending with the close-out visit. Coordinator services include recruitment, screening, subject enrollment, study visits/procedures, investigational drug services, administration and accountability, packaging, and shipping, source documentation, case report form completion, and long term record storage.
- Dedicated outpatient facilities include a fully equipped exam room and patient lounge for extended outpatient visits/IV infusions.