About TGH Clinical Research

Departmental Overview

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 for Outpatient 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.