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Training Materials

Contents

Online Presentations

ClinicalTrials.gov staff developed the online presentations listed below to help sponsors and investigators register studies on and submit results to ClinicalTrials.gov. PDF handouts and transcripts of each presentation are provided. The running time for each presentation is given in parentheses (minutes:seconds) after the presentation's title. Please note that the Protocol Registration and Results System (PRS) may have changed since these slides were developed.

Final Rule Webinar Series

The presentations below, originally offered as a series of three live webinars, provide responsible parties with information about the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11).

Overview of the Final Rule - Webinar 1 of 3 (60:02)
Deborah A. Zarin, MD, Director, and Rebecca J. Williams, PharmD, MPH, Assistant Director, ClinicalTrials.gov, National Library of Medicine (NLM)
Summarizes key provisions of the final rule, with a focus on the effective and compliance dates, applicability of the final rule, and new requirements for the submission of results information for applicable clinical trials of unapproved, unlicensed, or uncleared drug, biological, and device products. (September 27, 2016)

Final Rule Clinical Trial Registration Information Requirements - Webinar 2 of 3 (59:37)
Rebecca J. Williams, PharmD, MPH, Assistant Director, ClinicalTrials.gov, NLM
Summarizes who must submit "expanded" clinical trial registration information, when such information must be submitted, what constitutes registration information, and when the information must be updated. (October 5, 2016)

Final Rule Results Information Requirements - Webinar 3 of 3 (60:03)
Rebecca J. Williams, PharmD, MPH, Assistant Director, ClinicalTrials.gov, NLM
Summarizes who must submit "expanded" clinical trial results information, when such information must be submitted, what constitutes results information, and when the information must be updated.
The webinar also discussed the clinical trial information posting provisions, quality control review procedures, and when the obligation to update and correct clinical trial information ends. (October 11, 2016)

Overview of ClinicalTrials.gov and Related Policies

Overview of ClinicalTrials.gov (28:44)
Deborah A. Zarin, MD, Director, ClinicalTrials.gov, National Library of Medicine (NLM)
Provides an overview of the reasons for registering studies and submitting results, a history of ClinicalTrials.gov, and information on the data submission and review process (March 2011)

Key FDAAA Issues (9:23)
Deborah A. Zarin, MD, Director, ClinicalTrials.gov, NLM
Discusses key issues in the Food and Drug Administration Amendments Act (FDAAA) related to registering trials and submitting results (March 2011)

Submitting Results Data

The presentations below provide an overview of each results module, including required data elements, review criteria, and examples of common errors.

Results: Participant Flow Module (17:08)
Rebecca J. Williams, PharmD, MPH, Assistant Director, ClinicalTrials.gov, NLM (September 2014)

Results: Baseline Characteristics Module (12:25)
Rebecca J. Williams, PharmD, MPH, Assistant Director, ClinicalTrials.gov, NLM (September 2014)

Results: Outcome Measures and Statistical Analyses Module (13:03)
Deborah A. Zarin, MD, Director, ClinicalTrials.gov, NLM (September 2014)

Results: Adverse Event Module (12:30)
Rebecca J. Williams, PharmD, MPH, Assistant Director, ClinicalTrials.gov, NLM (September 2014)

PRS Guided Tutorials (BETA)

The PRS Guided Tutorials (BETA) provide step-by-step instructions for entry of results information into the ClinicalTrials.gov Protocol Registration and Results System (PRS). The tutorials can be accessed in an interactive format or as printable PDFs.

If you would like to provide feedback to help us further develop content and features for the PRS Guided Tutorials, please take our survey.

Note: Registration content is in development and planned to be added to the tutorials in late 2019.

PRS Guided Tutorials (BETA): Includes audio narration, expandable images, downloadable PDF versions, and other interactive features. [Requires a browser that supports HTML5.] If your browser is not compatible, you will be redirected to a page with direct links to the PDF versions, which contain the same content as the interactive format.

Results Database Train-the-Trainer Workshop

Future Workshops

The next Train-the-Trainer Workshops are planned for Nov. 4-5, 2019, and May 18-19, 2020, at the NIH campus in Bethesda, MD. The registration application is now open for the November workshop.

This workshop is led by ClinicalTrials.gov staff and provides training to key personnel who are involved in submitting results to ClinicalTrials.gov for their academic organization (see "Who should attend?" below). It consists of interactive presentations and hands-on results data entry exercises with the Protocol Registration and Results System (PRS). The workshop topics include: the basic organizational principles of the PRS results modules, step-by-step data entry instructions for common study designs, Results Review Criteria, and navigating the ClinicalTrials.gov website help resources. The workshop will also provide an overview of key laws and policies, including the registration and results submission requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and its implementing regulations (42 CFR Part 11).

Who should attend?

The target attendees are personnel responsible for providing ClinicalTrials.gov training and support to others at their academic institution/organization. The workshop will provide the attendee with basic tools for helping to ensure results from their organization are successfully submitted to ClinicalTrials.gov. The workshop is best suited for individuals who have beginner or intermediate knowledge of the results database and are already familiar with the PRS, FDAAA 801, and 42 CFR Part 11.

Requirements

The workshop is free and attendees are responsible for their own travel and hotel accommodations. Attendees are required to bring their own laptop with wireless connectivity capability. Space is limited.

Workshop Materials

The materials listed below are from the workshops that were held in June and September 2015. Please note that because all workshop materials were accompanied by oral presentations, the PDF files alone may not be sufficient for understanding the requirements. In addition, the ClinicalTrials.gov website and PRS have changed since these slides were developed. The November 2019 workshop materials will be added after the workshop.

This page last reviewed in August 2019