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Policies & Guidelines




NINDS and NIH policies, regulations, and guidelines are influenced by many Government organizations including HIPAA, OHRP AND FDA. The following are government organizations:

 

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Monitoring Policies

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Miscellaneous

  1. Ancillary Studies of NINDS-supported Clinical Trials and Epidemiological Studies
  2. Conversion of Grant to Cooperative Agreement
  3. Requiremenet for No-cost Extension Progress Reports
  4. Incremental Funding of Large Multicenter Studies
  5. Clinical Research Application Process for Large/Expensive Clinical Research Projects
  6. Manual of Procedures (MOP)
  7. MOP Template [MS Word] [PDF]
  8. Guidelines and Policies for Clinical and Data Center Operations
  9. Pilot Studies for Clinical Trials in Neurological Disorders
  10. Progress Assessment Checklist for NINDS Clinical Studies
  11. NINDS Quality Assurance Guidelines
  12. Reporting of Accural and Demographics
  13. Enrollment of Subjects into Clinical Trials - Information Requested on Participant Availability at Clinical Sites [MS Word] [PDF]
  14. Applicant Interview or "Reverse-site Visit"
  15. Multicenter/Phase III Clinical Trial Cooperative Agreement
  16. Supplemental Infomation [MS Word] [PDF]
  17. NINDS Terms of Award for Clinical Research

 

 

 

 

 

 

 

 

 

 

 

 

 

Last updated March 3, 2014