1. User-Friendly Interfaces: EDC systems have evolved to provide intuitive and user-friendly interfaces. This simplifies data entry for investigators and site staff, reducing the potential for errors and improving efficiency. 2. Modular and Configurable Systems: Many EDC systems now offer modular and configurable setups, allowing researchers to customize the system to fit the specific needs of their trial. This flexibility enhances adaptability across different study designs. 3. Interactive Electronic Source Data (eSource): EDC systems are moving toward interactive eSource solutions, where source data can be directly entered into the EDC system during patient visits. This eliminates the need for double data entry and enhances accuracy. 4. Integration of ePRO and Wearable Data: EDC systems can integrate patient-reported outcomes (ePRO) and data from wearable devices. This enables real-time collection of patient data and enhances the completeness and accuracy of trial information. 5. Real-Time Data Validation: EDC systems can include real-time data validation checks, alerting investigators to potential errors or inconsistencies during data entry. This reduces the need for extensive data cleaning post-trial. 6. Automated Queries and Issue Management: EDC systems can automatically generate queries when data inconsistencies are detected. Investigators can address these queries directly within the system, improving communication and issue resolution. 7. Remote Monitoring and Risk-Based Monitoring (RBM): EDC systems support remote monitoring, allowing sponsors and monitors to review data without being physically present at the site. This aligns with risk-based monitoring approaches and improves efficiency. 8. Electronic Signature and Audit Trail: EDC systems offer electronic signature capabilities, which facilitate the signing of important documents electronically. Additionally, audit trails provide a comprehensive record of all changes made to the data, ensuring data integrity.

1. Welcome
INNOVATIONS IN ELECTRONIC DATA CAPTURE
(EDC) SYSTEMS FOR CLINICAL TRIALS
SK ARSHIYA SIDDIQUA
B PHARMACY
176/082023
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2. INDEX
• Introduction
• Innovations in EDC
• Benefits
• Features
• Challenges in implementing and using EDC systems
• Advantages
• Conclusion
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3. INTRODUCTION
•Electronic data capture (EDC) systems have revolutionized clinical trials, making
them faster, more reliable, and more efficient than ever before.
•An electronic data capture system (EDC) is a computerized system designed to
collect clinical data in electronic format for use mainly in human clinical trials .
•EDC systems are software designed to automate the clinical trials data collection
system.
•EDC are used in all phases of clinical trials to collect, manage and report clinical
and laboratory data.
•EDC systems used for data entry in a single site trial to the more sophisticated
multi site international trial with remote data entry over the web.
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4. INNOVATIONS IN EDC
 Technological advancements are the main driving force behind
evolving EDC systems.
 Data urge for more efficient data capture and processing analysis
lays the foundation for the intersection of EDC systems into clinical
trials.
 Some innovations include:
 Integration with remote technologies and mobile phones
 Integrating with electronic health records (EHR) and other clinical
systems
 The intersection of predictive systems and artificial intelligence.
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6. BENEFITS
 EDC allows clinical trial data to be collected and securely stored in a real time
in a centralized data base, giving researches immediate access to timely and up to
date information.
 EDC system offers improved accuracy compared to paper based data collection
methods.
EDC systems also help to reduce data collection errors and inconsistencies by
providing automated information checks and validation rules
 Improves data quality, faster data collection , faster data entry and monitoring,
enhanced data security, data management simplified.
Streamline work flows that results in faster and more efficient trials.
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7.  Cost savings
EDC systems can reduce costs associated with
paper based data collection, such as printing,
shipping and data entry.
Time savings
EDC systems can reduce the time required for data
collection, cleaning, analysis and helping to speed
up the clinical trial process.
Data accuracy
EDC systems can improve data accuracy
completeness reducing the risk of errors and
improving the reliability of study outcomes.
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8. FEATURES
• The prime features of the electronic data capture (EDC) systems
for clinical trial include:
• Electronic case reports forms (eCRFs)
• Adverse event reporting modules
• Electronic patient reported outcomes(ePRO)
• Integration options via application programming interfaces(APIs)
• Connected devices and wearables integration
• Case-based data collection
• Survey data collection
• Medication modules
• Integration with clinical trial management
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9. CHALLENGES IN IMPLEMENTING AND USING EDC SYSTEMS
• EDC does not allow central data cleaning at point of entry or traditional manual
CRF tracking upon receipt so alternative approaches are required.
• EDC systems can be complex, especially for large clinical trials with a large
amount of data. This can make the implementation process more challenging and
time consuming.
• Specific site training is required and site staff need to be encouraged to submit
data immediately following participants visits instead of batching data entry
• . Data quality – ensuring data quality and accuracy can be a challenge with EDC
systems, requiring robust quality control measures and data validation checks.
• Technical issues- technical issues such as a server down time, software bugs and
system crashes can disrupt the smooth operation of EDC systems.
• User experience- EDC systems must be user friendly with clear instructions and
minimal training required for all users.
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10. ADVANTAGES
• EDC system playa a crucial role in clinical
trials
• EDC penetration in to clinical trials has
revolutionized the way researches conduct
trials.
• Some advantages of EDC for clinical trials
are:
1. Improved data quality
2. Enhanced efficiency
3. Real time data entry and monitoring
4. Data security and compliance
5. Remote and mobile data capture
6. Efficient data monitoring
7. Data integration
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11. CONCLUSION
• Electronic data capture(EDC) system are likely to continue
evolving , with greater integration with other technologies and most
sophisticated data analysis capabilities.
• With their many benefits EDC systems have transformed clinical
trials, offering greater efficiency, accuracy, and cost savings.
• The benefits of EDC outweigh the challenges however it requires
continual re-assessment and re-evaluation of novel processes as
they are developed and implemented.
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12. Thank You!
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9121151622/623/624
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