The National Center for Advancing Translational Science (NCATS), Trial Innovation Networks (TINs) will serve as clinical, data, and recruitment centers for the NIH HEAL Pain Management Effectiveness Research clinical trials.  These TIN centers will provide the following resources to all awardees:

  • Central IRB service- see https://trialinnovationnetwork.org/elements/central-irb/
  • Execute a Master Clinical Trial Agreement with the individual clinical sites- in coordination with awardees
  • Develop a final study protocol- in coordination with study team investigators
  • Provide study design support, statistical analysis and interpretation of results for manuscripts and publications
  • Finalize recruitment and retention plans with the site investigators before initiation of the trial
  • Assist with recruitment
  • Develop trial documents, including the Manual of Procedure or Standard Operating Procedures; materials for site investigators, case report forms and training materials for study personnel with the study team
  • Train clinical site investigators and staff for the trials. Training areas include, but are not limited to, regulatory requirements, Good Clinical Practice, adverse event reporting, human subject protections, informed consent, and NIH policies and procedures
  • Develop and maintain a data management system for trial data collection and storage and adverse event reporting
  • Provide randomization support
  • Provide clinical operations and monitoring support
  • Monitor enrollment and retention at the individual sites and work with sites that fail to meet their enrollment targets
  • Prepare reports for the Data and Safety Monitoring Boards
  • Provide logistics for face to face meetings of the consortium’s investigators, including a cross award investigator kick off meeting in the planning phase
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Form Approved OMB# 0925-0648 Exp. Date 06/2024