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NINDS is part of the
National Institutes of
Health

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NINDS is responsible for monitoring in clinical research it supports. Data and safety monitoring of a clinical trial is commensurate with the risks posed to the study participants with the size and complexity of the study. The NINDS is responsible for oversight of data and safety monitoring in all supported clinical research, ensuring that monitoring systems are in place, that the quality of the monitoring activity is appropriate, and that the Institute is informed of recommendations emanating from monitoring activities.

The following links will provide you with necessary information regarding the development of a monitoring plan for an NINDS funded clinical trial. Monitoring of data integrity and patient safety are required aspects of NIH and NINDS trials.

• NINDS Guidelines for Data and Safety Monitoring in Clinical Trials
  
  
• NINDS Policy on Monitoring NINDS-Supported Clinical Research
  
  
• Budget Guidelines for Data and Safety Monitoring
  
  
• Data Safety Monitoring Board
  
  • DSMB Report Outline
  
  
• Safety Monitoring Committee
  For trials not requiring a DSMB, a Study Monitoring Committee (SMC), appointed by the principal study investigator, will undertake monitoring responsibilities.
  
  
• Independent Medical Monitor
  The Independent Medical Monitor is responsible for ongoing monitoring of reports of SAEs submitted by the clinical centers to ensure good clinical care and to quickly identify safety concerns.
  
  
• Medical Safety Monitor
  
  
• Terms and Conditions of the Award
  
  
• Requirement for No-cost Extension Progress Reports
  
  
• Study Initiation Flow [PPT version] [PDF version]
• Incremental Funding of Large Multicenter Studies
• NINDS Quality Assurance Guidelines
• Reporting of Accural and Demographics
• Gender and Minority Supplemental Information [MS Word] [PDF]
• Ancillary Studies of NINDS-supported Clinical Trials and Epidemiological Studies
• Conversion of Grant to Cooperative Agreement
• NINDS Data and Safety Monitoring Board Conflict of Interest and Confidentiality Statement

Last updated March 26, 2008