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  Clinical Trials and Human Subjects Research

Some activities must or should be registered with the National Institutes of Health project registration system. If the activity is funded by NIH and meets the definition of a "clinical trial," then the grant contract requires registration. If there is no contractual obligation to register, researchers should consider registration since it could benefit the field and health care generally.

"A research study in which one or more human subjects are prospectively assigned. to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes."

  
    Overview:


Miami maintains an institutional account with the Protocol Registration and Results System (PRS) at NIH. That account is maintained by an administrator. Researchers, PI's, can request that a user account be established with the PRS system by contacting the institutional administrator. Once the user account is established, the user uploads project documents and notifies the administrator. The administrator accesses the account and releases the information to NIH. NIH can then release the information to other researchers and the public.

 
  PRS Information:


System Organization Name: MiamiU

Miami Administrator: Neal Sullivan (sullivnh@miamioh.edu)

Accessing the PRS System: https://clinicaltrials.gov/ct2/manage-recs/register

 

 

 

 

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Please contact The Office for the Advancement of Research and Scholarship if you have questions about this web site: 513-529-3600
    or email Neal Sullivan at sullivnh@miamioh.edu or Jennifer Sutton at suttonja@miamioh.edu

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