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9/13/2017 11:36:06 AM
New eCTD Compliant Interventional Protocol Template and Instructions Available

The Protocol Development page was updated on September 2017 to include a new eCTD Compliant Interventional Protocol Instructional Template. This new protocol template for interventional clinical trials contains enhanced instructions and content, and is part of ongoing efforts to meet FDA requirements for all IND/IDE/DMF submissions to be in eCTD format. Select Clinical Research Support and choose Protocol Development to access the available protocol templates and associated guidances and tools.
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