FDA New Electronic Data Capture Guidance- Inspectional Record 2015
03 Nov 2015
Online Event
Key Topics
FDA definitions for data elements
FDA definitions of E records, and E CRF
The requirement for original source data to support every data element
FDA definitions of Source data and types of electronic source data systems
What types of electronic data elements pose noncompliance challenges
The requirements for electronic data - origination, authorization, signatures, and data tracking
Participant input and questions
Preventing non compliance by sponsor due diligence at the investigator site
Who should Attend
Attendees from:
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- Inspectional Record 2015 - 03 Nov 2015, Online Event (54536)
FDA New Electronic Data Capture Guidance- Inspectional Record 2026
Important
Please, check "FDA New Electronic Data Capture Guidance- Inspectional Record" official website for possible changes, before making any traveling arrangements
