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Validity : 22nd Apr'24 to 02nd May'24
FDA Electronic Data Capture Guidance- What is the impact on Investigator Site Inspectional Source Record Requirements?
- 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 non-compliance challenges
- Preventing non-compliance by sponsor due diligence at investigator site
- Participant input and questions
Overview of the webinar
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.
Who should attend?
This webinar will provide valuable assistance to all personnel in:
- Human Subjects Research
- Data Management
- Healthcare interested in exploring the field of Clinical Research
- Clinical Research Coordinators
- Principal Investigators/Physicians
- Administration in charge of Clinical Research
- Regulatory Compliance
Why should you attend?
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".
Faculty - Miss.Sarah Fowler Dixon
Sarah Fowler-Dixon, PhD, CIP currently works with the human research protection program at 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, guidelines, reporting, and training for researchers and staff. She often works with state and federal authorities such as the NIH and FDA. She has provided consultation regarding ethical, federal, state, and institutional requirements in the design and execution of projects. Dr. Fowler-Dixon teaches research ethics and regulatory affairs, the fundamentals of clinical research management and mentors honors students in the Clinical Research Management program.