ClinicalTrials.gov: Entering Results

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Registering your study with ClinicalTrials.gov and entering study results are necessary steps for investigators to be compliant with regulations. This UB CTSI Educational Modules video takes a close look at the Protocol Registration and Results System (PRS) and explores:

  • The importance of entering study results
  • Preparing to enter results
  • The four scientific modules of entering the results
  • Additional information that may need submitting in the PRS, and
  • Links to useful resources and step-by-step guides

Developed by Lynn Jagodzinski, CTSI Clinical Research Regulatory Administrator, and Urmo “Mo” Jaanimägi, CTSI Quality Assurance Specialist, UB Clinical and Translational Science Institute
Presenter: Urmo “Mo” Jaanimägi, CTSI Quality Assurance Specialist, UB Clinical and Translational Science Institute
Running Time: 15 minutes

Questions?
Contact Lynn Jagodzinski, UB CTSI Clinical Research Regulatory Administrator, at lynnjago@buffalo.edu, or UB CTSI Quality Assurance Specialist Urmo “Mo” Jaanimägi at uj@buffalo.edu.

Additional resources:
University at Buffalo’s ClinicalTrials.gov Registration and Results Guide: http://www.buffalo.edu/content/dam/www/ctsi/Cores/RecruitmentSpecialPop/toolkit/ClinicalTrialsgov%20Registration%20and%20Results%20Guide%209.24.2021.pdf
PRS Guided Tutorials: 
https://prsinfo.clinicaltrials.gov/tutorial/content/index.html
How to Report: http://clinicaltrials.gov/ct2/manage-recs/how-report
Basic Results Data Elements Definitions: http://prsinfo.clinicaltrials.gov/results_definitions.html
PRS User Guide: Located on Main Menu (Help) in database
All Training Materials: http://clinicaltrials.gov/ct2/manage-recs/present
10 Minute Webinars for each results module: https://prsinfo.clinicaltrials.gov/webinars
Checklists and Templates (for each scientific module): https://prsinfo.clinicaltrials.gov/results_table_layout/ResultSimpleForms.html
Helpful Hints (with common study designs examples): http://prsinfo.clinicaltrials.gov/ResultsExamples.pdf
Glossary: https://clinicaltrials.gov/ct2/about-studies/glossary