2014 - Fundamentals of the new FDA inspectional record requirements for EDC and EDE clinical trials

Instructor: Stephen Schwartz - CIC
Description:
This webinar deals with basics of new FDA inspectional record requirements for EDC/EDE clinical trials. Case history of multiple site trial that uses EDC to be presented. For electronic record function procedures, changes might be possible to remain in compliance with the compliance inspectional standards.
We will compare the text of the guidance to current FDA regulations.
Discuss the FDA current inspectional practice.
Explore investigator documentation practices that are FDA acceptable.
Additional options as offered by webinar participants.
Pharma and Investigators seek to minimize the burden of documentation in the conduct of clinical trials. The use of Electronic Data Capture for source documents coupled with Direct Data Entry still requires significant investigator site record documentation to comply with FDA compliance inspection requirements. Study data that does not comply with the inspectional standards will not likely be accepted by the FDA. FDA enforcement actions are possible against both the investigators and sponsors. We now have a new and much debated final GUIDANCE.
There are still questions. The guidance addresses Electronic Data Submission, Electronic Records, and the standards for computerized data capture and reporting systems. This guidance does not fully address the investigator site procedures that may be required for compliance. This webinar will address the investigator site electronic records function as it presents an interface between all three of the guidance functions.
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. The inspectional compliance objectives have not changed. The GCP compliant conduct of the clinical trial must be documented for all clinical trial functions. The case study will illustrate what happens without this procedural documentation.
Objectives of the Presentation:
Does the new guidance reduce or change the burden of documentation for investigators and sponsors where electronic records/ case histories/ source documents are utilized?
Exactly what study data do not now require source documentation?
What original source documentation is still required for an inspection?
Who can Benefit:
Clinical Research Coordinators and investigators
Medical Record personnel
Clinical CRA Monitors
Clinical Program Managers
Clinical Quality Assurance Auditors
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