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FDA New Electronic Data Capture Guidance - What is the impact on Inspectional

FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements

Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields inspectional non compliance.The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirementsPrice : $139.00Contact Info:MentorHealthPhone No: 1-800-385-1607FaX: 302-288-6884


12 Apr 2016 @ 10:00 am

12 Apr 2016 @ 11:00 am

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar

Organised by

NetZealous (deactivated)

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