Virtual | Virtual

Event Title

ClinicalTrials.gov: Essentials for Academic Medical Centers

July 14 - 30, 2026

Date:: July 14 - 30, 2026
Day1:: Tue, Jul 14 1:00 p.m. - 02:00 p.m. ET
Day2:: Wed, Jul 22 1:00 p.m. - 02:00 p.m. ET
Day3:: Thu, Jul 30 1:00 p.m. - 02:00 p.m. ET

Register here for the live panel session that best fits your schedule or area of interest:

Attend online via Adobe Connect

Panel One: July 14: 1:00 PM ET
CDER, NLM | NIH and CDRH

Panel Two: July 22: 1:00 PM ET
CDER, NLM | NIH and OCLP

Panel Three: July 30: 1:00 PM ET
CDER, NLM | NIH and CBER

Visit CDER Small Business and Industry Assistance (SBIA) Homepage

About this Event (Hosted by CDER SBIA)

This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov. Specialists from the Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), Office of Clinical Policy (OCLP) and the Center for Biologics Evaluation and Research (CBER) within the U.S. Food and Drug Administration (FDA), and the National Library of Medicine (NLM) within the National Institutes of Health (NIH) will address frequently asked questions regarding regulatory obligations and the ClinicalTrials.gov Protocol Registration and Results System (PRS).

This training begins with a required, pre-recorded video that you can complete at your own pace prior to registering for the live panel session that best fits your schedule or area of interest. Upon completion of the pre-recorded training, we encourage you to submit questions for our expert panel to address during the live sessions. You can submit your questions by emailing ClinicalTrials.govAMCTraining@fda.hhs.gov or by including them when you register for a live session. The panel will use your questions to guide the discussion and provide relevant, practical answers. The live panel sessions are designed to build upon the information presented in the on-demand video.

These sessions will help you and your team understand when and how to register and report clinical trial information to ClinicalTrials.gov and meet data transparency requirements. By completing the pre-recorded training and joining the live virtual panel, you will leave with practical information in order to share clinical trial information with the public accurately and on time.

On-Demand Video – Please View Before Registering

After viewing the video, please submit any questions you would like the expert panel to answer. You can:

Email your questions to ClinicalTrials.govAMCTraining@fda.hhs.gov or
Submit them during the live session registration process

Intended Audience

Academic Medical Centers
- ClinicalTrials.gov administrators
- Office of Clinical Research
Academic researchers
Sponsor-investigators
Principal investigators

Topics Covered

ClinicalTrials.gov Registration and Results Reporting Requirements: Explore critical deadlines and submission requirements for ClinicalTrials.gov registration and results reporting to ensure federal compliance.
Common Compliance Pitfalls and Corrective Actions: Examine frequent registration and reporting errors, quality control best practices, and guidance for addressing non-compliance issues.
Center-Specific Guidance from CDER, CBER, and CDRH: Hear from center representatives on unique requirements and regulatory nuances applicable to different product types.
Features of the Protocol Registration and Results System (PRS): Gain insight into the capabilities and functionality of the modern PRS interface.
Expert Tips for Protocol Registration and Results Submission: Receive practical guidance from ClinicalTrials.gov experts on submitting protocol registration and results information accurately and efficiently.
Available Tools and Resources: Discover tools and resources available to support ClinicalTrials.gov registration and results reporting activities.

Presentation: ClinicalTrials.gov Registration and Reporting: What You Need to Know

Laurie Muldowney, M.D.
Deputy Director
Office of Scientific Investigations (OSI) | Office of Compliance (OC) | CDER | FDA

Presentation: ClinicalTrials.gov: Legal Requirements

Jennifer Vuong, Pharm.D.
Consumer Safety Officer
Compliance Enforcement Branch | Division of Enforcement and Postmarketing Safety
OSI | OC | CDER | FDA

Presentation: Where and How to Report Trials for Posting on ClinicalTrials.gov

Anna M. Fine, Pharm.D., M.S.
Director
National Library of Medicine | National Institutes of Health

Panel Moderator

Laurie Muldowney, M.D.
Deputy Director
OSI | OC | CDER | FDA

Panelists

Tuesday, July 14: 1:00 PM ET

Jennifer Vuong, Pharm.D.
Consumer Safety Officer
OSI | OC | CDER | FDA

Anna M. Fine, Pharm.D., M.S.
Director, ClinicalTrials.gov
NLM | NIH

Ouided Rouabhi, M.S.
Acting Director
Division of Clinical Evidence & Analysis 1 | Office of Product Evaluation and Quality | CDRH | FDA

Wednesday, July 22: 1:00 PM ET

Miah Jung, Pharm.D., M.S.
Senior Pharmacologist
OSI | OC | CDER | FDA

Anna M. Fine, Pharm.D., M.S.
Director, ClinicalTrials.gov
NLM | NIH

Tracy L. Cutler, MPH
Senior Health Policy Analyst
Office of Clinical Policy (OCLP) | Office of the Chief Medical Officer (OCMO | FDA

Thursday, July 30: 1:00 PM ET

Krisana Lee, CRNP
Consumer Safety Officer
OSI | OC | CDER | FDA

Stacey Arnold, Ph.D.
Results Subject Matter Expert
NLM | NIH

Dennis T. Cato
Associate Director. Bioresearch Monitoring
Division of Inspections and Surveillance (DIS) | Office of Compliance and Biologics Quality (OCBQ) | CBER | FDA

Continuing Education (CE)

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
SOCRA who 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.
SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.