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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)

Updated Quality Control and Posting Procedures Webinar

ClinicalTrials.gov Webinar: Updated Quality Control and Posting Procedures (43:29)
Rebecca Williams, PharmD, MPH, Acting Director, ClinicalTrials.gov, NLM

On January 1, 2020, ClinicalTrials.gov will update posting procedures for submitted results information for applicable clinical trials. Consistent with 42 CFR Part 11, the National Library of Medicine (NLM) will publicly post submitted results information within 30 days of submission, regardless of whether the quality control (QC) review process is complete. This presentation describes the updated procedures and includes a question-and-answer session. (October 15, 2019)

PRS Guided Tutorials

The PRS Guided Tutorials provide step-by-step instructions for registering a study, uploading study documents, and submitting results information into the ClinicalTrials.gov Protocol Registration and Results System (PRS). The tutorials also include Quick Overview Guides, a PDF library, annotated figures for various study design examples, and answers to common questions. [Requires a browser that supports HTML5.]

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

Results Database Train-the-Trainer Workshop

Workshop Materials

The materials from the August 2021 Results Database Train-the-Trainer virtual workshop are listed below. The topics covered during the workshop included an Overview of the Clinical Trial Disclosure Landscape, a PRS System Overview, NIH Requirements for Clinical Trials Registration and Reporting, PRS Results Module Introductions, and Example Studies for Results Data Entry. Each topic below includes a recording, where applicable, and accompanying materials as a PDF.