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.
Last updated November 4, 2013