The Manual of Procedures (MOP) (PDF, 462kb), is a document used to facilitate consistency in protocol implementation and data collection across patients and clinical sites. Further, the MOP provides reassurance to all participants that scientific integrity and patient safety are closely monitored and increases the likelihood that the results of the study will be scientifically credible.
Quarterly Progress Report
A quarterly report is required during the start-up and recruitment and enrollment of participants stages of a multisite clinical research project that exceeds $1M direct cost in any given funding period. The NINDS may request this report for complex multisite studies in which funding does not exceed $1M, this will be decided on a case-by-case basis.
ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and internationally. It provides patients, family members, health care professionals and members of the public access to information about clinical trials for a wide range of diseases and conditions. Registration in the ClinicalTrials.gov registry works in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.
A repository and dissemination tool for all NINDS CDEs for Investigators to utilize for trials being planned, and ongoing research.
Monitoring Guidelines and Policies for Clinical Research
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.