A message from Merit Cudkowicz and Christopher Coffey, March 18, 2020:
Dear NeuroNEXT PIs and Coordinators,
We would like to share some updates regarding NeuroNEXT Network response to the evolving COVID-19 crisis.
As you all know, the COVID-19 situation and response is evolving rapidly. There has already been and will likely continue to be significant impact on NeuroNEXT Clinical Study Site (CSS) staff and participants. We know that many sites have been required to transition study staff to work remotely and to limit on-site clinical research activities. Participant travel has also been impacted in some cases. The CCC and DCC have already received many communications and questions from NN sites. The caring and efforts demonstrated by CSS and NN site staff have been amazing (although not surprising)!! Many thanks to all!!
The NIH has issued some general guidance related to NIH funded studies (see link below). The guidance addresses things like transition to remote participant visits, impact on study and grant timelines, strain on site resources, etc. The PPIs and their study teams will be reviewing this guidance closely as they develop study specific guidance and guidelines which will be shared with CSS teams in the coming days.
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-087.html
The Core study teams at the CCC and DCC, with guidance from NeuroNEXT Leadership, are working closely with the Protocol PIs to develop study specific guidance that will include recommendations and requirements for participant follow up and reporting for the NN107 and NN108 studies. The NN109 and NN110 study teams and PPIs are also working to determine what impact there might be to site and study start up and how any impact may be mitigated. The NN106 study team is also assessing whether or not ongoing chart extraction and/or site close-out activities may be impacted.
We encourage you and your CSS teams to continue to reach out to the study teams at the CCC and DCC with any questions or concerns and to be on the lookout for forthcoming study-specific guidance . The teams at the CCC and DCC will do our best to respond as quickly as possible.
Wishing continued good health to all!!
Merit and Chris