The Food and Drug Administration (FDA), is announcing the following public workshop entitled “Coordinated Registry Network (CRN) for Devices Used for Acute Ischemic Stroke Intervention (DAISI).” The purpose of the public workshop is to obtain stakeholders’ input on the coordination of registries for Devices Used for Acute Ischemic Stroke Intervention. FDA is soliciting input on all aspects of the workshop topics which include: Clinical Common Data Elements, Standardized Definitions, Case Report Forms, Informatics, Sustainability, Data Quality, and additional scientific, methodological, and clinical considerations for evaluating information obtained from registries. A discussion paper including background information and potential topics for discussion will be posted on this web page prior to the workshop.
- Date, Time and Location
- Federal Register Notice
- Draft Agenda
- Webcast
- Registration
- Contact Us
Date, Time and Location:
This meeting will be held February 2, 2017, beginning at 8:00 am – 5:00 pm at the following location:
National Institutes of Health (NIH) Campus
9000 Rockville Pike
Ruth L. Kirschstein Auditorium
Natcher Conference Center, Bldg. 45
Bethesda, MD, 20892
The entrance for the public workshop participants (non-NIH employees) is through the NIH Gateway Center located adjacent to the Medical Center Metro, where routine security check procedures will be performed.
Webcast
Due to the nature of this public meeting, there will be no webcast or transcription service.
Draft Agenda
Time
Subject
07:30 – 8:00 AM
Registration
8:00 – 8:30 AM
Welcome Introductions
8:30 – 9:15 AM
Coordinated Registry Network Value Proposition and Prior Experience
9:15 – 10:15 AM
Introduction of Working Groups
- Clinical Core Data Elements and Standard Definitions
- Informatics and Infrastructure Development
- Sustainability and Long-Term Value
10:15 – 10:30 AM
Break
10:30 – Noon
Breakout Sessions
- Clinical Core Data Elements and Standard Definitions
- Informatics and Infrastructure Development
- Sustainability and Long-Term Value
12:00 – 1:00 PM
Lunch
1:00 – 2:30 PM
Breakout Sessions Continued
2:30 – 2:45 PM
Break
2:45 – 4:00 PM
Breakout Sessions Continued
4:00 – 5:00 PM
Working Group Summaries, Next Steps, and Closing Remarks
Registration to Attend the Workshop
If you wish to attend this Workshop, you must register by 4:00 pm on January 26, 2017. There is no fee to register for the Workshop and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Peggy Roney, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5671, [email protected].
Contact Us
For questions regarding workshop content please contact: Jamie Waterhouse, Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, rm. 2611, Silver Spring, MD 20993, 301-796-3063, email: [email protected].