Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance 2016 is a webinar that covers topics such as:
- 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 the investigator site
- What types of electronic data elements pose noncompliance challenges
- Participant input and questions
Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance 2016 is intended for:
- Medical Record Personnel
- Clinical Research Coordinators and Investigators
- Clinical Program Managers
- Clinical CRA Monitors
- Clinical Quality Assurance Auditors
