Conference on 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 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 sevenFDA 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 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. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. 

She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. 

Prior to joining Washington University, Dr. Fowler-Dixon was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.   Price : $139.00      Contact Info:   MentorHealth Phone No: 1-800-385-1607 FaX: 302-288-6884  support@mentorhealth.com Event Link: http://bit.ly/FDA-New-Electronic-Data-Capture http://www.mentorhealth.com/   LinkedIn  Follow us – https://www.linkedin.com/company/mentorhealth  Twitter Follow us – https://twitter.com/MentorHealth1  Facebook Like us– https://www.facebook.com/MentorHealth1