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

Training Options  Duration: 60 Minutes  
Monday, December 4, 2017   |   10:00 AM PDT | 01:00 PM EDT

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 requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation".

Why should you Attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required.

Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives.

Areas Covered in the Session:

FDA definitions for data elements
FDA definitions of source data and types of electronic source data systems
The requirement for original source data to support every data element
The requirements for electronic data-origination, authorization, signatures and data tracking
What types of electronic data elements pose noncompliance challenges
Preventing non compliance by sponsor due diligence at investigator site
Participant input and questions

Who Will Benefit:
Clinical Research Coordinators and Investigators
Medical Record Personnel
Clinical CRA Monitors
Clinical Program Managers
Clinical Quality Assurance Auditors

Speaker Profile
Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions.

Price - $139
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