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FDA New Electronic Data Capture Guidance - What is the impact on Inspectional

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 seven FDA inspectional priority objectives. Areas Covered in the Session:FDA definitions for data elementsFDA definitions of source data and types of electronic source data systemsThe requirement for original source data to support every data elementThe requirements for electronic data-origination, authorization, signatures and data trackingWhat types of electronic data elements pose noncompliance challengesPreventing non compliance by sponsor due diligence at investigator siteParticipant input and questionsWho Will Benefit:Clinical Research Coordinators and InvestigatorsMedical Record PersonnelClinical CRA MonitorsClinical Program ManagersClinical Quality Assurance Auditors


10 Feb 2016 @ 10:00 am

10 Feb 2016 @ 11:00 am

Duration: 1 hours

Timezone: GMT -5:00


Online Webinar



Organised by

NetZealous (deactivated)

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