Guidance for Results and Adverse Events Reporting

Adverse Event Reporting:

A tabular summary of all anticipated and unanticipated serious adverse events (meeting or exceeding a specific frequency threshold). Each serious or other adverse event, it must include: the adverse event term, affected organ system, number of participants at risk, and number of participants affected, by study arm or comparison group.

Serious Adverse Event Template:

http://prsinfo.clinicaltrials.gov/results_table_layout/DataEntryTable_SAEForm.pdf

Other (Not Including Serious) Adverse Event Template:

http://prsinfo.clinicaltrials.gov/results_table_layout/DataEntryTable_FreqAEForm.pdf

Adverse Events Base Results Data Element:

http://prsinfo.clinicaltrials.gov/results_definitions.html#AdverseEvents

Adverse Events Module:

http://prsinfo.clinicaltrials.gov/webinars/module8/index.html

How to Submit Your Results:

For certain clinical trials subject to the requirements of Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801), Responsible Parties must submit scientific and administrative information about the results of the trial to the ClinicalTrials.gov results database. (See FDAAA 801 Requirements.).  Results must be submitted within 1 year of the last participant visit/encounter.

http://clinicaltrials.gov/ct2/manage-recs/how-report

Pre-Submission Checklist:

A short reminder checklist to assist in result data entry:

http://prsinfo.clinicaltrials.gov/pre-submission-checklist.pdf

Common Errors:

Overview of common errors identified in submitted records with “basic results”:

http://prsinfo.clinicaltrials.gov/CommonErrors.pdf

Helpful Hints “Basic Results”:

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 measure with a scale:

http://prsinfo.clinicaltrials.gov/ResultsExamples.pdf

“Basic Results” Data Element Definitions:

Details on the information that is entered into PRS regarding results, including adverse events:

http://prsinfo.clinicaltrials.gov/results_definitions.html

Results Detailed Review Items:

Items evaluated by ClinicalTrials.gov after results have been submitted: http://prsinfo.clinicaltrials.gov/ResultsDetailedReviewItems.pdf

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