Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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Training Materials

Contents

Final Rule Webinar Series

ClinicalTrials.gov is offering a series of three live webinars to provide responsible parties with information about the final rule for Clinical Trials Registration and Results Information Submission (42 CFR part 11). Each webinar will cover a different aspect of the final rule, including an overview of which applicable clinical trials are covered, what clinical trial registration and results information is required under the "expanded" requirements, and when the requirements take effect. Each webinar will be archived and publicly available for online viewing after the event. There is no cost to participate in the webinars.

To view the webinar(s) live, please register for each date you plan to attend:

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.

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)

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 September 2016