Trial Registration and Results Reporting on ClinicalTrials.gov _ eMedEvents

1. 20/10/2021, 11:00 Trial Registration and Results Reporting on ClinicalTrials.gov | eMedEvents  Introductory Offer Sign In Assistant Are you an Organizer?   Maximize CME/CE Allowance SEARCH  ‹ › Internal Medicine/Family MedicineOncologyRadiologyPsychiatryPediatricsEmergency MedicineNeurologyCardiologyDermatologyDentists Obstetrics and Gynecology Home / Online CME / Webcasts / Trial Registration and Results Reporting on ClinicalTrials.gov  Trial Registration and Results Reporting on ClinicalTrials.gov  By ComplianceOnline   Webcasts60 MinutesUSD 199.00 REGISTER  Overview Conference Summary Price Trial Registration and Results Reporting on ClinicalTrials.gov is organized by ComplianceOnline. Specialties Who Will Bene?t: • 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 Why Should You Attend: The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clari?es 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. Target Audience Contact Us 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 ful?ll 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. Description: This session will explore the challenges clinical teams and sponsoring organization face in determining if a clinical trials is quali?ed 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. Areas Covered in the Webinar: • Discuss key factors to consider, when deciding if its quali?ed 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 ?le ?nal 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 Price Registration Name Category Last Date Price https://www.emedevents.com/online-cme-courses/webcasts/trial-registration-and-results-reporting-on-clinicaltrials-gov 1/3

2. 20/10/2021, 11:00 Trial Registration and Results Reporting on ClinicalTrials.gov | eMedEvents Recorded Link Only Fee Final Fee USD 199.00 Recorded USB Only Fee Final Fee USD 249.00 Specialties Research and Clinical Research Target Audience Pharmaceutical Companies Pharmaceuticals Contact Us Toll free Number 1(800) 828-2059 Email support@eMedEvents.com Chat Assistant Live Chat Reviews Given by People No Reviews available. Be the ?rst to write a review. Add Review Recommended Conferences Research and Clinical Research Research and Clinical Research Webcasts Webcasts USD 399 USD 199     Good Clinical Practice R2 addendum only Sunshine Act Reporting: Clari?cation for Clinical Research Research and Clinical Research Research and Clinical Research https://www.emedevents.com/online-cme-courses/webcasts/trial-registration-and-results-reporting-on-clinicaltrials-gov 2/3

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