FDA Electronic Data Capture Guidance - What is the impact on Investigator Site Inspectional Source Record Requirements?

Duration: 90 Minutes
The FDA guidance has rapidly increased the use of electronic data capture. Pharma and Investigators seek to minimize the burden of documentation in the conduct of clinical trials. Pursuance of that goal without focus on inspectional compliance can incur a failed regulatory inspection.
New Electronic Data Capture Guidance
Instructor: Sarah Fowler Dixon
Product ID: 501033

FDA regs 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".

We will present a case history of a multiple site trial that used EDC and failed the inspectional requirements. There are many noncompliant electronic record function procedures. The sponsor could have or should have addressed these challenges to using electronic data capture/ direct data entry procedures.

Areas Covered
  • FDA definitions of E records, and E CRF
    • 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 the investigator site
    • Participant input and questions

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.

Objectives of the Presentation
  • How to choose investigators who can be compliant with FDA inspectional requirements for electronic data capture and direct data entry
  • How to identify study data elements that require hard copy source documentation
  • How to design your e CRF to address the origination, authorization, and signature inspectional requirements
  • How to support your electronic data capture systems with study documentation such as SOP, 1572, CV, delegation of authority, training logs and more
  • How to determine if the investigator site patient source document system is open or closed
  • How to choose a compliant all electronic data capture system, all hard copy, or hybrid system
Who can Benefit
  • Clinical Research Coordinators and Investigators
  • Medical Record Personnel
  • Clinical CRA Monitors
  • Clinical Program Managers
  • Clinical Quality Assurance Auditors
Recorded Session for one participant
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Instructor Profile:
Sarah Fowler-Dixon, PhD, CIP is an 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 led 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.
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