Investigators and others who conduct clinical trials may be subject to mandatory registration of trials and reporting of results at clinicaltrials.gov, requirements that were instituted in 2007. The Food and Drug Administration (FDA) has recently determined that many academic and individual investigators are not familiar with these requirements and has asked for IDSA’s help in disseminating the information.
If you conduct clinical trials, please review FDA’s announcement (PDF) to see if you are subject to the registration and reporting requirements. Additionally, there is information in the announcement about changes to informed consent documents for trials initiated on or after March 7, 2012.
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