You're invited to online webinar on "Trial Registration and Results Reporting on ClinicalTrials.gov"

Live Webinar: Trial Registration and Results Reporting on ClinicalTrials.gov When: Tuesday August 31, 2021 - 01:00 PM Duration: 60 Minutes.

Register Now for Live Virtual Webinar

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. 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.
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

Register soon because space is limited.

We hope you’re able to join us!