Following funding approval by the National Advisory Neurological Disorders and Stroke Council, NINDS Office of Clinical Research staff will invite study team members of Phase III clinical trials and multi-site Phase II trials to a 1-day meeting at NINDS in Rockville, Maryland. The goals of this meeting, scheduled prior to award, are to introduce the study team to the NINDS staff that will be involved in the trial, share NIH resources available to the study team, and devote time to work on start up activities.
The start-up meeting will generally involve a 3-hour discussion in the morning, with afternoon sessions available to develop specific recruitment plans and learn more about integrating Common Data Elements into your case report forms. A generic agenda(pdf, 99 KB) provides an overview of the discussion topics. Attendance by the PI (and Co-Is), lead coordinator/project manager, and study statistician should be in-person, whereas the business office staff may participate either in-person or by teleconference.
NINDS program staff will send potential dates for the meeting. Information that will be requested from the study team in advance of the meeting include:
- Study synopsis(pdf, 22 KB)
- Draft consent document
- List of proposed participating sites
- Study timeline
- How many from your study team will be attending.
As you plan your application, consider including time and costs for this meeting.
Contact the appropriate Program Officer/ Program Director if you have any questions.