We use cookies to personalise content and ads, to provide social media features and to analyse our traffic. We may also share information about your use of our site with our social media, advertising and analytics partners. Read more about our Privacy Policy.

I got it!

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

When

12 Apr 2016 @ 10:00 am

12 Apr 2016 @ 11:00 am

Duration: 1 hours

Timezone: GMT -5:00


Where

Online Webinar


Organised by

NetZealous (deactivated)

Recent Publications in Health

Recent Videos in Health

Recent News in Health

#JustPublished! #HealthCare specialists: who should be tested for COVID-19 infections in the EU/EEA? Check the upd… https://t.co/khT4uWfU7G

@ECDC_EU - 26 Feb 2020 17:00

#ESMH update on #coronavirus with an insight from @ECDC_EU: what the EU could do now ? https://t.co/XeZEn8TCPY

@ECDC_EU - 26 Feb 2020 16:48

New developments on electronic cross-border health services announced today, click here to find out more

@EU_Health - 26 Feb 2020 15:21

Recent Speakers in Health