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Guidance for Results and Adverse Events Reporting

Adverse Event Reporting - information on the requirements for reporting adverse events

Guide to Results Data Entry - (CHEST, 2009 Jul;136(1):295-303) - article includes summary results reporting requirements, brief descriptions of the results database modules, and suggestions for preparing results submissions

Pre-Submission Checklist (pdf) (DRAFT) - a short reminder checklist to assist in results data entry

Common errors (pdf) (DRAFT) - overview of common types of errors identified in submitted records with "basic results"

Helpful hints (pdf) - tips on entering results data, including three examples of common study models (parallel design, crossover design, and diagnostic accuracy studies), reporting measure types, including information on reporting outcomes measured with a scale.

"Basic Results" Data Element Definitions (DRAFT) - details on the information that is entered about results, including adverse events, via the PRS.

Results Detailed Review Items (pdf) (DRAFT) - describes items evaluated by ClinicalTrials.gov after results have been submitted.

Basic Results Provisions (pdf) - extracted from FDAAA 801.

Delayed Submission of Results - information on submitting certifications or requests for extension

Recorded Presentation (Adobe Flash: 37 minutes) and accompanying >slides (pdf)

  • Module 1: ClinicalTrials.gov Overview and PL 110-85 Requirements
  • Module 2: "Basic Results" Data Entry
  • Module 3: Posted Results at ClinicalTrials.gov
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