Description

Clinical trials are conducted in a variety of institutional settings, and if your organization is engaged in clinical trials it is likely that you face complex problems, issues and challenges on a regular basis whether you are a research administrator in a central sponsored projects office, in a medical school department, or in a teaching hospital or research institute. This interactive workshop will examine key administrative, financial, and regulatory issues that arise in the planning, funding and conduct of clinical trials, including:

• The unique complex regulatory environment for clinical trials
• Key negotiation issues that often arise in a clinical trial agreement
• Managing research conducted under INDs with faculty acting as the clinical trial sponsor
• The intricacies of managing a clinical trial budget and expenditures
• Exploring institutional models to manage regulatory challenges such as research billing, ClinicalTrials.gov regulations, contracting with VAs, and NIH clinical trials
• Electronic tools and solutions to manage the clinical trials enterprise
• Closing-out clinical trials

In addition, the experienced workshop faculty will provide participants with tips, tools and practical solutions to address the problems they face, so come prepared to share your most challenging issues and problems with the faculty and fellow participants.

Learning Objectives

• Participants will gain an understanding of the nuances involved in developing and managing a clinical trial budget and project expenses;
• Participants will learn how to manage multifaceted issues that often arise in a negotiation of trial agreements;
• Participants will learn about the complexities of managing federal clinical trials and clinical trial network grants;
• Participants will learn how clinical trials are closed-out and how to manage post-close-out institutional obligations and responsibilities.

Pre-Requisites

A working knowledge of clinical trials. This session will build on standard operating procedures and best practices.

Program Level:

Intermediate