Electronic Data Capture & Remote Data Capture

Electronic Data Capture & Remote Data Capture

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  Electronic Data Capture& Remote Data Capture Presented by: PATHAN AZHER KHAN
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  • EDC • RDC •HISTORY • EVOLUTION OF CLINICAL DATA CAPTURE • CRITERIA FOR IDENTIFYING AN EDC • REGULATORY GUIDELINE ON EDC • EDC ISSUES • VALIDATING ELECTRONIC SOURCE DATA CONTENTS
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  EDC Electronic data capture(EDC): The process of collecting data into a permanent electronic form. NOTE: “Permanent” in the context of these definitions implies that any changes made to the electronic data are recorded via an audit trail. See also data entry, data acquisition. or A computerized system design for the collection of data in electronic format for use mainly in human trials.
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  FUTURE
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  History Medical professionals FDA 1990s web-basedtechnology provided an opportunity to greatly improve the efficiency and accuracy of clinical data capture (EDC) systems became available in the marketplace &
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  Evolution of clinicaldata capture • case report forms (CRF) • 1980s, PCs were introduced to clinical trial use • centralized process • PCs at the investigator site allowed for the introduction of decentralized clinical data capture which became known as remote data capture (RDC). • In RDC, computerized data was routinely transferred from each investigator site to the sponsor through some File Transfer Process (FTP) • 1990s, web-based technology
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  HINDRANCE A main hindrancein moving to more electronic source data is the belief that electronic data cannot be validated—a requirement of the FDA.
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  CRITERIA FOR ANEDC Basic Criteria: Automated support: • Data Collection, • Data Extraction, • Data Query, • Data Validation, • Data Manipulation, • Data Sharing, • Reporting, & • HIPPA compliant HEALTH INSURANCE PORTABILITY & ACCOUNTABILITY ACT-1996
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  Additional Advanced Criteria: •Simple installation and study set up • User friendly interface • Flexible to meet variable research needs • Electronic Patient Reported Outcomes (ePRO) • Easy data exportation and database maintenance • Hybrid capability to fit in paper sourced data • Fast and satisfactory technical support and System upgrades • Cost-effectiveness
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  REGULATORY GUIDELINE ONEDC: • Qualification of central laboratories • Verification of transfer and conversion processes of electronic data • Verification of data by direct access • Confirmation of received data
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  Qualification of centrallaboratories : sponsor must conduct the system audit and/or assessment SOP for all processes CSV must be conducted in a planned manner. Computer System Validation.
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  Verification of transferand conversion processes of electronic data • Specifications for electronic data capture should be established. • Specifications on compatible software and hardware used for electronic data capture should be defined. • For testing purpose, the sponsor should receive and check the electronic data of test results from the central laboratories. • he sponsor should confirm the procedures to correct the test results at the central laboratories, and check the process for obtaining revised data.
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  Verification of databy direct access patient IDs, dates, and other information between test reports and other source documents by direct access, in order to ensure authenticity of the data of each subject. Confirmation of received data Missing or redundant data.
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  Requirements of theGCP Record Keeping: Article 26 & Article 41 Data handling: using an electronic data processing systems (including remote electronic data systems) Article 26, Paragraph 1-3
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  Article 26, Paragraph1-3  Ensure and document that the electronic data processing systems fulfill the sponsor’s established requirements for completeness, accuracy, reliability and consistent intended performance (i.e. validation)  Maintain the operating procedures  Ensure that the systems are so designed as to permit data correction in such a way that the data correction are documented and that all records of correction of entered data remain undeleted as logs distinguishable to the inputter as well as to the corrector (i.e. to maintain audit trail, input trail, and edit trail);  Maintain a security system for the data  Maintain the adequate backup of the data  Prepare and maintain a list of the individuals who are authorized to make data correction, and  Keep the blinding in case of a blinded clinical trial.
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  Article 26, Paragraph4 : • Data converted during the processing, the sponsor should ensure that it is always Possible to compare the original data with the processed data. Article 41 of the GCP : • Record keeping at the site, including the source documents.
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  EDC issues (1) FDA, (2)Lack of mobile hardware, and (3) Attitude.