Training Materials

Contents

• Online Presentations
  • Overview of ClinicalTrials.gov and Related Policies
  • Applying for a Protocol Registration System Account and Registering a Clinical Trial
  • Submitting Results Data
• Results Database Train-The-Trainer Workshop
  • Workshop Slides
  • Example Studies for Results Data Entry

Online Presentations

ClinicalTrials.gov staff developed the online presentations listed below in March 2011 to provide more information for sponsors and investigators who are registering a trial or submitting results with ClinicalTrials.gov. Adobe PDF handouts and transcripts of each presentation are included. The running time for each presentation is given in parentheses after the presentation's title (minutes:seconds).

Overview of ClinicalTrials.gov and Related Policies

Overview of ClinicalTrials.gov (28:44)
Deborah A. Zarin, M.D., Director, ClinicalTrials.gov, NLM
Provides an overview of the reasons for registering trials and submitting results, a history of ClinicalTrials.gov, and information on 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 Amendments Act related to registering trials and submitting results.

Applying for a Protocol Registration System Account and Registering a Clinical Trial

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

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

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 (17:32)
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 Events 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 at 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 the ClinicalTrials.gov Protocol Registration System (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 PDFs alone may not be sufficient for understanding the requirements of FDAAA 801, the PRS, or the results review process. In addition, the content of the 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.

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

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.

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.

Outcome Measures Module (PDF)
An overview of the Outcome Measures module results requirements and step-by-step instructions for entering an Example Parallel Design Study.

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.

Example Studies for Results Data Entry

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

• Parallel Study Design Example and Answer Key
• Cross-over Study Design Example and Answer Key
• Dose Escalation Study Design Example and Answer Key
• Factorial Study Design Example and Answer Key
• Multiple Period Study Design Example and Answer Key