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  4. Webinar: Learn About ClinicalTrials.gov Modernization and How to Provide Input - 03/06/2020 - 03/06/2020
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Webcast

Event Title
Webinar: Learn About ClinicalTrials.gov Modernization and How to Provide Input
March 6, 2020


Date:
March 6, 2020
Time:
1:00 PM - 2:00 PM ET
CDER Small Business and Industry Assistance Webinar Series

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The National Library of Medicine (NLM) issued a Request for Information (RFI) to obtain stakeholder feedback on modernizing ClinicalTrials.gov.

NLM is asking for your input on how to deliver an improved user experience on an updated platform that will accommodate growth and enhance efficiency. Creating a roadmap for modernization requires feedback from a wide array of stakeholders including sponsors and investigators who submit clinical trial information to the site on how to continue serving, balancing, and prioritizing their information needs.

We’re asking for your input on how it can best continue to serve your needs for many more years to come. This presentation will describe our effort and the recently issued Request for Information (RFI) to obtain your input.

TOPICS COVERED

INTENDED AUDIENCE

  • Study sponsors and investigators who use the Web-based submission system called the Protocol Registration and Results System (PRS) to ensure that their clinical studies are registered and have results reported on ClinicalTrials.gov.
  • Researchers using ClinicalTrials.gov information to inform their work or to improve the clinical research enterprise (example, perform landscape analysis to understand what research has been completed or where gaps in research exist).  
  • Clinical research coordinators who need to understand what information needs to be collected or reported to ClinicalTrials.gov.

LEARNING OBJECTIVES

  • Learn about the ClinicalTrials.gov modernization effort
  • Understand how to submit comments that could shape enhancements to ClinicalTrials.gov
  • List the three relevant topic areas where NLM is seeking input.

SPEAKER

Rebecca Williams, PharmD, MPH
Acting Director
ClinicalTrials.gov | National Library of Medicine | NIH

RESOURCES

  1. ClinicalTrials.gov Modernization Webpage
  2. Public Notice Request for Information

CONTINUING EDUCATION

This course:

  • SOCRA accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
  • has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.

QUESTIONS

Please contact info@sbiaevents.com for all technical questions.

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