CRES Event: Forecasting Regulatory Requirements

04 Nov CRES Event: Forecasting Regulatory Requirements

FORECASTING REGULATORY REQUIREMENTS

Do you feel confident anticipating regulatory requirements for new studies?

In this quarter’s CRES event, Karen Adams, ITHS Regulatory Specialist, will present a framework to navigate major federal regulatory requirements for a new study. By attending this event, you will:

• Learn a framework to identify regulatory requirements for different types of studies
• Hear case studies that illustrate how to plan for regulatory requirements
• Work in small groups to apply regulatory requirements for research case studies
• Use a tool to anticipate applicable regulations and plan for future requirements

This event is applicable to Research Coordinators at all levels who work in a health sciences research environment. The case studies include research projects using drugs, devices, and non-traditional medical interventions in a variety of patient populations.

For those joining via webcast:  We will distribute the forecasting regulatory requirements tool to be used in conjunction with your institution’s regulatory policies. If you wish to facilitate the discussion portion of the session at your own site, please request a copy of the sample case studies from the speaker in advance of the session.

A version of this session was originally presented at the ITHS Networking to Enhance Development Conference in May, 2015.