Clinical Trials Registration - University of Wisconsin–Madison

More documents

Recommendations

Info

ICMJE Requirements Any research study thatprospectively assigns . . . toone or more health-relatedinterventions to evaluate theeffects on health outcomes Includes Phase I Drugs, surgical procedures, devices,behavioral treatments, dietary interventions,and process-of-care changes Prospective registration, i.e., registered inClinicalTrials.gov before the first patient isenrolledUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION6ICMJE
International Committee of Medical Editors Who is ICMJE? Uniform Requirements forManuscripts Submitted toMedical Journals 714 journals use the Uniform Requirements www.icmje.org/jrnlist.html7ICMJEUW-MADISON COMMITTEE ON CLINCAL TRIALS REGISTRATION
Page 1 and 2: Clinical Trials Registration:Your O
Page 3 and 4: FDA Requirements All Phase II-IV in
Page 5: FDA Consequences Penalties for fail
Page 9 and 10: Comm. on Clinical Trials Registrati
Page 11 and 12: Registering trials on ClinicalTrial
Page 23 and 24: Websitewww.grad.wisc.edu/research/h
Page 25 and 26: Contact the Presenters25UW-Madison

Clinical Trials Registration - University of Wisconsin–Madison

Create successful ePaper yourself

Delete template?

Save as template?