FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements 2016
12 Apr 2016
Webinar
Key Topics
FDA definitions of source data and types of electronic source data systems
FDA definitions for data elements
The requirements for electronic data-origination, authorization, signatures and data tracking
The requirement for original source data to support every data element
Preventing non compliance by sponsor due diligence at investigator site
What types of electronic data elements pose noncompliance challenges
Who should Attend
Medical Record Personnel
Clinical Research Coordinators and Investigators
Clinical Program Managers
Clinical CRA Monitors
Clinical Quality Assurance Auditors
Past Events
FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements 2016 - 12 Apr 2016, Webinar (56535)
FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements 2026
Important
Please, check "FDA New Electronic Data Capture Guidance - What is the impact on Inspectional Record Requirements" official website for possible changes, before making any traveling arrangements
Event Categories
Business: Human Resources (HR), Management, Risk Management
Education: E-learning, Education Technologies & Methods, Training
