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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 and submit results with ClinicalTrials.gov. Adobe PDF handouts and transcripts of each presentation are provided. The running time for each presentation is given in parentheses after the presentation's title (minutes:seconds). Note that the Protocol Registration and Results System (PRS) may have changed since these slides were developed.

Overview of ClinicalTrials.gov and Related Policies (March 2011)

Overview of ClinicalTrials.gov (28:44)
Deborah A. Zarin, M.D., 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 processes

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

Applying for a PRS Account and Registering a Clinical Study (March 2011)

PRS Information and Data Review Process (15:58)
Tony Tse, Ph.D., Program Analyst, ClinicalTrials.gov, NLM
Provides an overview of data entry using PRS and of the data review process conducted by ClinicalTrials.gov staff

PRS Accounts and Registration (6:33)
Annice M. Bergeris, Information Research Specialist, ClinicalTrials.gov, NLM
Discusses how to apply for a PRS account, enter study registration data, and modify a record. Provides an overview of the protocol review criteria

Submitting Results Data (September 2014)

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 (17:32)
Rebecca J. Williams, Pharm.D., M.P.H., Assistant Director, ClinicalTrials.gov, NLM

Results: Baseline Characteristics Module (12:25)
Rebecca J. Williams, Pharm.D., M.P.H., Assistant Director, ClinicalTrials.gov, NLM

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

Results: Adverse Event Module (12:30)
Rebecca J. Williams, Pharm.D., M.P.H., Assistant Director, ClinicalTrials.gov, NLM

Results Database Train-The-Trainer Workshop

This workshop was targeted to National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) institution personnel who have a responsibility 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 for data entry in PRS.

The materials listed below are from the workshop hosted in October 2012. ClinicalTrials.gov is considering offering more workshops, and more information will be made available when the dates are confirmed.

Please note that because all workshop materials were accompanied by oral presentations, the Adobe PDFs 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 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 medical journal editors.

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.

Example Studies for Results Data Entry

The following example study records and example study papers are fictional and were created for the purposes of illustrating key concepts for results data entry in PRS. Each document below is provided as a PDF file.

This page last reviewed in September 2014