Trial Registration and Results Reporting on ClinicalTrials.gov

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.

Why Should You Attend:

The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain clinical trials to ClinicalTrials.gov, in accordance with Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801). The Final Rule has been in effect since January 18, 2017.

The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition of the publication of research results generated by a clinical trial. To fulfill this obligation organizations and individuals can provide the World Health Organization (WHO) Trial Registration Data Set required by ICMJE to ClinicalTrials.gov or a WHO primary registry. The ICMJE expects authors to meet all results reporting requirements of their funding and regulatory agencies. If there are no such reporting requirements, the ICMJE encourages authors to submit results information to the same database on which their trials are registered.

In this session we will review the challenges clinical teams and sponsoring organization face in determining if a clinical trials are qualified and required to be registered, what are the parameters as per HHS final rule and NIH policy and discuss time frame for updates to be posted and reporting of the results to be completed.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

This training session is designed for entry through intermediate level professionals involved in:

• 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