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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 notifies the adminstrator of the status (see below).

 
  PRS Information:


System Organization Name: MiamiU

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

Accessing the PRS System: https://clinicaltrials.gov/ct2/manage-recs/register (or use search terms: PRS Clinical Trials)


 

Responsibilities: At the request of the researcher, the Miami Research Ethics and Integrity Office (MREI) as the institutional administrator, creates an account in the Protocol Registration and Results System (PRS). Account information is sent by PRS by email to the researcher. The researcher uploads study materials and notifies MREI which releases the records for NIH review. The MREI is notified upon NIH approval that the information can be made available to the public.

Submission requirements: Some data elements are required by ClinicalTrials.gov, while others are optional but may be required by other organizations. Users are encouraged to submit all data elements in order to provide a complete description of the study.
A ClinicalTrials.gov staff member will review the study record after it is released (submitted) and before it is published on ClinicalTrials.gov. This review will focus on apparent validity (when possible), meaningful entries, logic and internal consistency, and formatting. You may be asked to clarify items or make corrections to the record before publication. Please note that the review process may take up to a few days. Ensuring that the record is consistent with the ClinicalTrials.gov protocol review criteria (PDF) before releasing it will expedite publication on the site.

Help: For basic help with using PRS, review the Quick Start Guide found in the Help section of the PRS main menu. More detailed instructions are available in the PRS User's Guide, also found on the PRS main menu.

Required Registration Updates:
Researchers should update their records within 30 days of a change to Individual Site Status and Overall Recruitment Status data elements or Completion Date (see Primary Completion Date data element on ClinicalTrials.gov). Other changes or updates to the record must be made at least every 12 months. It is recommended that the Record Verification Date be updated at least every 6 months for studies that are not yet completed, even if there were no changes to the record.

 

 

 

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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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