This course provides the practical skills needed to construct and negotiate study budgets that appropriately compensate investigative sites for resource needs required as a result of clinical research protocols.
Analyze protocols to assess resource needs
Create study budgets that adequately reimburse sites for their time and effort
Use various approaches for structuring study budgets
Utilize software to develop budgets and track study costs
Identify important aspects when negotiating study budgets
Clinical Trial Personnel (Clinical Research Coordinators, Investigators) responsible for preparing and implementing study budgets
Sponsor Representatives in the pharmaceutical industry, Contract Research Organization and Consultant Representatives whose function is to design and/or apply study budgets for sites
The course will be led by one of the following instructors:
Karen Gilbert, B.S., C.C.R.A.
Marcellina N. Oparaoji, Ed.D., B.S.N., R.N., C.C.R.P.
Lily Romero, P.A., C.C.R.C
Jackie Stader, C.O.T., C.C.R.C.
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Day 1: 8:30 a.m. – 5:00 p.m.
- Protocol Dissection Techniques: Assessing protocol feasibility; determining resource needs
- Negotiation Considerations: Identifying negotiable items; performance-based contracts; payment schedules
- Developing the Study Budget: Identifying line items; accounting for the site’s time; fee for service, fixed and fixed-unit pricing structures; case study
- Technology to Enhance the Budget Development Process
- Protocol Dissection Techniques: Using spreadsheets; clinical study software programs
- Tracking Payments and Financial Reports: Accounting systems; tracking and managing payments; financial reports
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
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Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-11-002-L01-P. Released: 3/11.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.