Specific services include:

• Develop Informed consent
• Prepare and develop new project IRB submissions
• Facilitate training and education with clinical personnel to facilitate study start-up
• Complete NMH/NMG and CRU submissions (i.e. research tests)
• Submit sponsor-required regulatory documents (i.e., FDA 1572, Financial Disclosure Form, etc.)
• Develop  and negotiate clinical trial budgets
• Provide Research Coordinator Support
• Develop study-specific recruitment materials/advertising
• Provide ongoing financial management of study accounts
• Provide internal regulatory support to obtain IRB approval
• Submit amended protocols to the IRB
• Assist staff and investigators with preparation prior to (and following) external audits

The CTU also provides central oversight of research personnel (clinical research coordinators or CRCs, research nurses, and research assistants). Specific responsibilities include:

• Supervise hiring of new CRCs
• Monitor certifications for new personnel (CITI human research protection, CPR, ethics and security, HIPAA, IT and email security, and SOP review/maintenance)
• Perform initial and ongoing formal training, education, monitoring, and mentorship
• Conduct ongoing personnel performance reviews and evaluations
• Provide training in all university-required certifications, NMH/NMG policies, research billing, privacy issues, Good Clinical Practices, electronic medical records, and eIRB/eNOTIS use
• Standardize procedures and policies for research personnel

Without a properly negotiated budget and continued oversight, you and the institution may realize a financial loss on a clinical trial. The sponsor often provides a template budget and in most cases these budgets are negotiable. The CTU will work with sponsors to assure the budget is adequate to cover the relevant research costs incurred during the trial.

The Clinical Trials Unit provides expert budgeting and negotiating assistance to Investigators as part of the study start-up process. The budget review process focuses on costs based on the researchers’ time and effort, expenses incurred from medical procedures performed, distinguishing standard of care procedures versus research procedures, and identifying study costs that are often overlooked (i.e., screening efforts, unscheduled visits, IRB fees, patient stipends/travel, monitoring visits/audits, records retention and adverse event reporting).

For ongoing studies, the CTU will provide budget management including monitoring monthly budget statements, invoicing sponsors per contract guidelines, assisting with removal of inaccurate charges, tracking study payments/purchase orders, processing payments for research services (i.e. NMH/NMG costs), and closuring of research accounts to ensure revenue and expenses are accurate.  

The goal of the CTU data management staff is to create an efficient data management process and ensure the delivery of a clean, locked database with a minimal amount of errors at study completion. The CTU offers two stages of data management:

1. Development of the data collection system during the design phase
2. Management of data during the trial. Data management services of the CTU include:    

• CRF design, distribution and implementation
• Database construction
• Data entry and verification
• Data validation
• Data coding
• Generation and resolution of queries for data discrepancies
• Report generation for data status