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:
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
Contact Lynn Jagodzinski, UB CTSI Clinical Research Regulatory Administrator, at email@example.com, or UB CTSI Quality Assurance Specialist Urmo “Mo” Jaanimägi at firstname.lastname@example.org.
University at Buffalo’s ClinicalTrials.gov Registration and Results Guide: download
PRS Guided Tutorials:
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
Contact any of the nine CTSI cores for a list of services and resources offered, and for answers to your research questions.