Online Presentations

ClinicalTrials.gov staff developed the online presentations listed below to provide more information for sponsors or 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.

Entering 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