The document discusses electronic data capture (EDC) and remote data capture (RDC) in clinical trials, highlighting their historical evolution, regulatory guidelines, and essential criteria for successful implementation. It addresses challenges faced in validating electronic source data and emphasizes the importance of proper data management, including audit trails and compliance with regulations. Additionally, it outlines the necessary specifications for software and hardware, as well as the responsibilities of sponsors in ensuring data integrity and security.

1. Electronic Data Capture & Remote Data
Capture
Presented by:
Pristyn Research Solutions
www.pristynresearch.com

2. • EDC
• RDC
• HISTORY
• EVOLUTION OF CLINICAL DATA CAPTURE
• CRITERIA FOR IDENTIFYING AN EDC
• REGULATORY GUIDELINE ON EDC
• EDC ISSUES
• VALIDATING ELECTRONIC SOURCE DATA
CONTENTS

3. 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.

4. FUTURE

5. History
Medical professionals
FDA
1990s web-based technology provided an opportunity to greatly
improve the efficiency and accuracy of clinical data capture
(EDC) systems became available in the marketplace
&

6. Evolution of clinical data 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

7. HINDRANCE
A main hindrance in moving to more electronic source data is the
belief that electronic data cannot be validated—a requirement of the
FDA.

8. CRITERIA FOR AN EDC
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

9. 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

10. REGULATORY GUIDELINE ON EDC:
• Qualification of central laboratories
• Verification of transfer and conversion processes of electronic
data
• Verification of data by direct access
• Confirmation of received data

11. Qualification of central laboratories :
sponsor must conduct the system audit and/or assessment
SOP for all processes
CSV must be conducted in a planned manner.
Computer System Validation.

12. Verification of transfer and 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.

13. Verification of data by 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.

14. Requirements of the GCP
Record Keeping:
Article 26 & Article 41
Data handling: using an electronic data processing systems (including remote
electronic data systems)
Article 26, Paragraph 1-3

15. Article 26, Paragraph 1-3
 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.

16. Article 26, Paragraph 4 :
• 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.

17. EDC issues
(1) FDA,
(2) Lack of mobile hardware, and
(3) Attitude.