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Study Conduct and Conclusion

Throughout conduct of the IISR study, TMC will obtain routine updates from the Sponsor-Investigator and/or institution in order to track progress against agreed study milestones. Furthermore, TMC will require at least one status update per quarter expected to contain information on enrollment (if applicable), projected publications, and study completion dates. 

Upon conclusion of the study, TMC requires a complete study report, which may be in the form of a manuscript, for submission to a peer-reviewed journal.  In cases where a manuscript is not developed, the complete study report must contain, at a minimum, a description of the following details:  

  1. Introduction
  2. Background
  3. Study Objectives
  4. Study Endpoints (primary and secondary)
  5. Study Design
  6. Study Population
  7. Study Procedures/Methods (including subject disposition) 
  8. Statistical Methods
  9. Results (including adverse events and complications) 
  10. Discussion
  11. Conclusion