Investigator Services

New Trials Start-up

The CTU staff assists investigators in the preparation of study documents for submission to the IRB. Specific services include:

• IRB submission of new protocols
• Preparation of HIPAA compliance documents and authorizations
• Informed consent preparation and negotiation
• Completion of NMH/NMFF and CRC submissions (i.e. research tests)
• Sponsor-required regulatory document completion (i.e., FDA 1572, Financial Disclosure Form, etc.)
• Budget preparation and negotiation for clinical trials
• OSR-CT submission preparation
• Development of study-specific recruitment materials/advertising
• Posting of clinical research trials on the CTU website.  Click here for instructions.

Budget Preparation and Negotiation 

Without a properly negotiated budget, you and the institution will lose money on a clinical trial. The sponsor often provides a template budget and in most cases these budgets are negotiable. However, on occasion it may be necessary for you to turn down participation in a clinical trial due to an inadequate budget. 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 and is offered complimentary to all investigators as part of the regulatory submission process. The budget review process focuses on costs based on the researcher's and coordinator's time and efforts, expenses incurred from medical procedures performed, distinguishing standard of care procedures versus research procedures, and identifying study costs that are often overlooked (i.e., supplies [examples: phlebotomy supplies, office supplies, fax, telephone], unscheduled visits, patient stipends/travel, monitoring visits/audits, records retention and adverse event reporting).

Financial Management

For ongoing studies the CTU will provide budget management including monitoring monthly budget statements, invoicing sponsor’s per contract guidelines, assist with removal of inaccurate charges, tracking study payments/purchase orders in CUFS system, process payments for research services (i.e. NMH/NMFF costs), and closure of research accounts to ensure revenue and expenses are accurate.  

Data Management

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

Biostatistical Support

Our goal is to foster long-term collaborations between biostatisticians and other scientists in all phases of the research process. During the design phase the statistician assists with such things as study design, selection of primary and secondary endpoints, sample size and power calculations, data collection instruments, and early stopping criteria. After a study is complete the statistician assists in data analysis, interpretation of results, and preparation of manuscripts.