UAB Synopsis Vol. 27, No. 10, March 17, 2008
On September 27, 2007, a US law was enacted that expands the types of clinical trials that must be registered in ClinicalTrials.gov, increases the number of data elements that must be submitted, and requires submission of study results. The law dictates deadlines for registration of phase 2 and 3 drug and device trials, designates who is responsible for registering a trial, and identifies categories of trials that must be registered. Information on mandatory clinical trial registration is available at:
Protocol Registration System (PRS) Information, http://prsinfo.clinicaltrials.gov, and PRS and US Public Law 110-85, http://prsinfo.clinicaltrials.gov/fdaaa.html.
Guidance from the NIH is available at:
http://http://prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf.