Researchers Toolkit

Post-Review/Pre-Funding

• Protocol Template for Definitive/Efficacy (Phase III) Trials The Protocol Template is an outline of a complete clinical trial protocol, including guidance on important content to include in each section of the protocol. The template can be downloaded as an MS Word file for adaptation by the study investigator ...more
  
  
• Manual of Procedures The Manual of Procedures (MOP) 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 ...more
  
  
• Clinical Trials Checklist
  The purpose of this checklist is to inform NINDS program staff and grantees of the necessary steps and documentation needed for starting a clinical trial.
  [MS Word Version] [PDF Version]
  
  
• Gender/Minority Information
  • Reporting of Accrual and Demographics
  • Enrollment Data Collection Tasks
  • Supplemental Data Template
    [MS Word Version] [PDF Version]
    
  
  
• Required registration to ClinicalTrials.gov
  ClinicalTrials.gov is a consumer-friendly database with information on more than 13, 500 clinical studies sponsored by the National Institutes of Health (NIH), other federal agencies, and private industry. The NLM and the ICJM have agreed that any clinical trial that is not registed on ClinicalTrials.gov prior to the first patient enrolled will not be allowed to publish study results in any ICJM journals. more...
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• Conversion to Cooperative Agreement
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• Certificate of Confidentiality
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• Budget Template
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• Monitoring Guidelines
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• NINDS Terms of Award for Clinical Research
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• Promoting Objectivity Avoiding Conflict of Interest
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• NIH Data Sharing