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March 04, 2011

March 2011 Regulatory Update: A Note from EmpiriStat’s Senior Program Manager

Part of our mission at EmpiriStat is to guide and inform our collaborators of new regulatory updates in this ever-changing world of research. From drugs to devices, the rules, standards, and regulations seem to change annually. It is part of our job to stay on top of these FDA updates, and focus on the impact it will have on your organization, and in your research.


The US Food and Drug Administration (FDA) recently issued a new rule intended to assist Sponsors and Investigators with the development of informed consent documents. Effective 07 March 2011, the following statement will be included in all applicable informed consent documents (and consent processes) for drug and device trials:


“A description of this trial will be available on, as required by U.S. law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.”


This statement is an amendment to the current informed consent regulations found in 21 CFR 50.25. It will apply to all studies initiated on or after 07 March 2011, with a compliance date of 07 March 2012.


Virtually all drug clinical trials conducted in the US have to be registered on the public database operated by the National Institutes of Health. The registry is wide enough to cover all trials of drugs and biologics except preliminary (Phase I) trials, including medical devices. Basic results of the trial must be posted to the registry once ended. Mandatory data fields to be submitted when a study begins include:

• Primary purpose and condition being studied
• Intervention name and type, including the name of product being studied
• Study design, type and phase
• Study start date and expected completion date
• Criteria for subject recruitment and planned numbers
• Primary and secondary outcome measures
• Name of sponsor and/or investigators
• Study location and contact details


This information must be registered within 21 days of enrolling the first participant.


By adding the new language to the informed consent (and it’s processes), this new rule gives the subjects participating in clinical trials a much broader sense of ownership of their choices and sacrifices they make. Unless noted under the discretion of study staff, no mention was ever made to subjects about the clinical trials registry during the consent process. currently contains 102,731 trials sponsored by the National Institutes of Health, other federal agencies, and private industry. Studies listed in the database are conducted in all 50 states and in 174 countries receives over 50 million page views per month 65,000 visitors daily.


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