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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. Adobe 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)

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Results Database Train-the-Trainer Workshop

This workshop was developed for staff at National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) institutions who are responsible for providing ClinicalTrials.gov training and support to investigators and other staff who must submit summary results information to ClinicalTrials.gov. The workshop focused on the data entry content and format requirements of the results database and provided hands-on tutorials on PRS data entry.

The materials listed below are from the workshops that were held in June and September 2015. ClinicalTrials.gov is considering offering more workshops, and information will be made available once the dates are confirmed.

Please note that because all workshop materials were accompanied by oral presentations, the Adobe PDF files alone may not be sufficient for understanding the requirements. In addition, the ClinicalTrials.gov Web site and PRS may have changed since these slides were developed.

Workshop Slides

Overview of FDAAA and Other Trial Registration Policies (PDF)
A description of who must register trials and submit results information, the trials that are covered, and the deadlines by which information must be submitted, based on FDAAA and the registration policy of the International Committee of Medical Journal Editors (September 2015)

NIH, Office of Extramural Research (OER) Perspective on FDAAA (PDF)
An overview of FDAAA compliance issues from the perspective of OER and tips and resources to help NIH extramural grantees (June 2015)

Protocol Registration and Results System (PRS) Overview (PDF)
A summary of the overall workflow in PRS and an explanation of key tools for Administrators (September 2015)

Participant Flow Module (PDF)
An overview of the Participant Flow module results requirements and step-by-step instructions for entering an example parallel design study (September 2015)

Baseline Characteristics Module (PDF)
An overview of the Baseline Characteristics module results requirements and step-by-step instructions for entering an example parallel design study (September 2015)

Outcome Measures Module (PDF)
An overview of the Outcome Measures and Statistical Analyses module results requirements and step-by-step instructions for entering an example parallel design study (September 2015)

Adverse Events Module (PDF)
An overview of the Adverse Events module results requirements and step-by-step instructions for entering an example parallel design study (September 2015)

Example Studies for Results Data Entry

The following example study records and study papers are fictional and were created to illustrate key concepts for results data entry in PRS. Each document below is provided as an Adobe PDF file.

This page last reviewed in February 2017