Notice of Change to the Data and Safety Monitoring Plan for PAR-18-422 "NINDS Efficacy Clinical Trials (U01 Clinical Trial Required)

Notice Number: NOT-NS-20-013

Key Dates
Release Date: January 03, 2020

Related Announcements
PAR-18-422

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice is to update the instructions regarding the Data and Safety Monitoring Plan for PAR-18-422.

Currently reads:

3.3 Data and Safety Monitoring Plan

Applicants should refer to the NINDS Guidelines for Data and Safety Monitoring in Clinical Trials (https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/NINDS-Guidelines-Data-and-Safety-Monitoring) when developing their DSMP.

Modified to read:

3.3 Data and Safety Monitoring Plan

Applicants should refer to the NINDS Guidelines for Data and Safety Monitoring in Clinical Trials (https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library/NINDS-Guidelines-Data-and-Safety-Monitoring) when developing their DSMP. Note that these guidelines have been updated to include a requirement for an independent statistician to report unblinded study analyses to the Data and Safety Monitoring Board.

All other aspects of this FOA remain unchanged.

Inquiries

Please direct all inquiries to:

Peter Gilbert, ScM
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-0870
Email: pgilbert@nih.gov