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If the details of clinical trials have been keeping you from participating in research, or if you would like to expand your research activities, learn more about the services NUCATS offers for clinical research trials. • • • • • • • • • • NUCATS offers a range of regulatory services to assist investigators with many of the administrative activities involved in meeting essential regulatory requirements. Regulatory Affairs serves as a liaison between the IRB, investigators, coordinators, sponsors, and other organizations. - IRB submission of new protocols and amendments
- Informed consent preparation and negotiation
- Completion of NMH, Cancer Center, VA, GCRC, or RIC submissions
- Preparation of HIPAA compliance documents and authorizations
- Sponsor-required regulatory document completion
- Regulatory binder assembly
- Investigator-initiated IND/IDE application support
To discuss regulatory affairs at NUCATS contact Hilary Reach • • • • • • • • • • Negotiating a study budget that satisfies both the investigator and the sponsor is an essential component for determining whether to participate in a study. NUCATS has provided a budget template and instructions to assist you in developing a successful study budget. Budget Template Instructions Budget Template Completed Budget Template (Example) NUCATS also offers clinical research financial experts who can provide you with personal assistance in drafting and negotiating financially viable study budgets. - Budget preparation and negotiation for clinical trials
- Budget review to ensure cost recovery
- ORSP-CT submission preparation
- Providing updates on contract progress as it moves through the Office of Research and Sponsored Programs (ORSP)
To discuss Financial Services at NUCATS, contact the Director of Clinical Operations, Tom Hancko • • • • • • • • • • Recruiting qualified subjects to meet enrollment goals for your clinical research study is always a challenging task. NUCATS recruitment coordinators can make the process easier by helping you identify the most effective marketing strategies. Once the recruitment tactics are implemented, our staff is skilled to field telephone calls from potential subjects and pre-screen callers for your study. - Strategic, HIPAA-compliant, marketing planning
- Design and development of recruiting materials including print and radio ads, flyers, direct mail campaigns, brochures, press releases, referral slips and more
- Negotiate IRB approval of recruiting materials with the IRB and sponsor
- Targeted media placement of advertisements and other recruitment materials
- Pre-screen and scheduling of potential subjects by experienced and dedicated call center staff
To discuss Recruitment Services at NUCATS, contact Marcella Oliver • • • • • • • • • • Investigators need qualified, experienced clinical research coordinators to handle the day-to-day details of conducting clinical research trials. NUCATS offers investigators access to its pool of trained and certified study personnel for full-time or part-time use. - Clinical coordination for Phase I-IV studies including data collection and CRF completion, obtaining informed consent, specimen draw/processing, regulatory affairs maintenance, subject recruitment assistance, and financial tracking
- Flexible scheduling to allow for full-time, dedicated research support, part-time coordinator assistance, or temporary help
To discuss Clinical Operations and Coordinator Services, contact the Director of Clinical Operations, Tom Hancko. • • • • • • • • • • The post approval monitoring program is a service for investigators to use to ensure that he/she and their research team are in compliance with the federal regulations, federal guidelines and ICH GCP, as well as IRB requirements. The program is conducted on active studies and ensures that the protocol is adhered to and the subjects welfare and safety are protected. It also ensures the integrity of the data. The investigator and their research team then have an opportunity to review the findings and request any assistance needed. To discuss Post Approval Monitoring, contact Annette Kinsella | |
