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

Monday, December 4 | 10:00 am - 11:00 am

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


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


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. 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 Contact Info: Netzealous LLC -MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com Website: http://www.mentorhealth.com/ Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/

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