Clinical Research Project/Program Management
Goal: Clinical trial project and program management incorporate a broad range of skill sets in order to plan, administer, track, evaluate and report activities and budgets involved in the health care product development process. The goal of this program is to introduce, affirm or enhance the participant’s understanding of the project management endeavor.
Objective: Through discussion, presentation, and interaction, this program will broaden the participants’ knowledge of the regulatory framework, project management art and science, planning and accounting, and their attitude and aptitude for achieving successful clinical trials.
Learning Objectives: Upon completion of the program, the attendee should be able to:
- Describe project management and basic risk management principles following PMI (Project Management Institute) guidelines (initiation, planning, execution, monitoring, controlling, and closing).
- Discuss the processes and procedures that are necessary to develop an infrastructure that will support the various tasks associated with Project Management in Clinical Research.
- Discuss how to incorporate IRB interaction activities into a project plan, focusing on issues involved in managing multiple investigational sites. Disaster recovery and contingency planning will be discussed.
- Discuss Organizational Dynamics and psychological issues in project management to promote effective team building. Describe conflict resolution strategies; discuss approaches to work effectively with different leadership and personality styles.
- Describe general start up issues including; budget development, cash flow issues and solutions, billing to CMS (Centers for Medicare & Medicaid Services), and contract management.
- Describe contract development topic issues including: intellectual property (IP) rights, publication, indemnification, payment schedule management, clinical trial sponsor interactions and negotiations.
- Describe various international regulatory bodies and their submission processes using the US Code of Federal Regulations (FDA/OHRP) as a baseline.
- Describe Project Management of the IND and IDE, review guidance documents, forms and accountability measures designated for use by industry and academic research sponsors and sponsor investigators.
- Discuss pharmacy issues related to risk management, safety, drug accountability, drug purity, randomization, blinding and unblinding, inventory control drug & device administration, dose calibration and dose escalation schedules.