Clinical Trial Registration
ClinicalTrials.gov is a service of the National Institutes of Health, and was developed by the National Library of Medicine (NLM). Its purpose is to "link patients to medical research." The site provides information about federally and privately supported clinical research in human volunteers.
The Protocol Registration System (PRS) is the part of ClinicalTrials.gov where investigators or sponsors register clinical trials. PRS accepts registration for all trials approved by an Institutional Review Board and that conform to the regulations of the appropriate national health authorities. Both interventional and observational trials are accepted.
The system facilitates registration of clinical trials in accordance with the International Committee of Medical Journal Editors (ICMJE) initiative requiring prior entry of clinical trials in a public registry as a condition for publication.
- NIH Guidance on Registration Requirements: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
- NIH Fact Sheet: http://prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf
- New Requirements for Data Elements: http://prsinfo.clinicaltrials.gov/s801-new-requirements.pdf
- ClinicalTrials.gov FAQ links:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-023.html
http://grants.nih.gov/grants/policy/hs/faqs_aps_clinical_trials.htm
The Ohio State University has established an organizational registry with the PRS system for OSU investigators to register protocols. Please contact the appropriate administrator to secure an individual login.
- For College of Medicine, contact Jill Springer - Jill.Springer@osumc.edu
- For Comprehensive Cancer Center, contact Kathryn Jelinek - Kathryn.jelinek@osumc.edu
- For College of Optometry, contact Karla Zadnik, OD, PhD - zadnik.4@osu.edu
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For Other Colleges, contact Sandra Meadows - meadows.8@osu.edu
