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Trial Registration and Results Reporting on ClinicalTrials.gov

Summary

  • Discuss key factors to consider, when deciding if its qualified clinical trial
  • Review rules, policies and guidelines to identify operational processes and best practices to register clinical trial, provide updates in a timely manner and file final reports
  • Review “Summary of HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov” in NEJM (Nov. 2016)
  • Provide overview of registration process on Clinicaltrial.gov website

Overview

This session will explore the challenges clinical teams and sponsoring organization face in determining if a clinical trials is qualified and required to be registered, determining time frame for updates to be posted and reporting the results. It will explain HHS Final Rule and NIH Policy on Registration/Reporting in ClinicalTrials.gov and provide the steps to registration process in clinicaltrials.gov site.

Who should attend?

  • Regulatory affairs professionals working in biotech, pharmaceutical products and medical device companies
  • Medical Affairs
  • Project managers
  • Clinical Research Associates (CRAs) involved in planning, monitoring, execution of trials and responsible for clinical trial reporting
  • Grant managers
  • Investigators

Marina Malikova

Expert

Dr. Malikova has over 15 years of experience in the clinical research field.  She has managed Phase I – IV studies involving investigational drugs, devices, biologics and combination products.  She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

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