Electronic Data Capture (EDC) systems are software applications designed to streamline the process of data collection and management in clinical trials and other research studies. EDC systems replace traditional paper-based data collection methods, allowing for more efficient and accurate data capture. Here are some key aspects of EDC systems and how they streamline data collection and management: Data Entry and Validation: EDC systems provide a digital platform for data entry, eliminating the need for paper forms. Researchers can enter data directly into electronic case report forms (eCRFs) using user-friendly interfaces. EDC systems often include built-in data validation checks, reducing data entry errors and ensuring data accuracy. Real-Time Data Capture: EDC systems enable real-time data capture, allowing researchers to enter data as it is collected during study visits or remotely. This reduces the time lag between data collection and data availability for analysis. Real-time data capture facilitates timely decision-making, data monitoring, and data quality control. Electronic Source Data Verification (eSDV): EDC systems support electronic source data verification, where the electronic data captured in the system can be compared with the original source documents, such as electronic health records or laboratory reports. This simplifies the process of data verification, ensuring data accuracy and reliability. Data Management: EDC systems streamline data management processes by automating tasks such as data cleaning, query management, and data reconciliation. They provide functionalities to track and resolve data queries, allowing efficient communication between investigators and data management teams. EDC systems also facilitate data exports and transfers to statistical analysis software. Remote Data Capture: EDC systems support remote data capture, enabling participants to enter data from their own locations using secure online portals. This eliminates the need for participants to travel to study sites for data entry, reducing participant burden and improving data collection efficiency. Data Security and Compliance: EDC systems employ robust security measures to protect data confidentiality and integrity. They adhere to regulatory requirements, such as the Health Insurance Portability and Accountability Act (HIPAA) in the United States and the General Data Protection Regulation (GDPR) in the European Union, ensuring compliance with data privacy and security standards. Data Monitoring and Auditing: EDC systems provide tools for data monitoring and auditing. They enable remote monitoring of data quality, allowing sponsors or monitors to review data in real-time, identify discrepancies or errors, and take necessary actions promptly. EDC systems also facilitate centralized data monitoring and remote audits, minimizing on-site visits and associated costs.

1. Welcome
ELECTRONIC DATA COLLECTION (EDC) SYSTEM:
STREAMLINING DATA COLLECTION AND MANAGEMENT
SHAZIA SAMA
PHARM-D 6th YEAR
Student ID :090/052023
10/18/2022
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2. INDEX
• INTRODUCTION TO EDC SYSTEM
• HISTORY
• USERS OF EDC SYSTEM
• CONTENTS OF EDC SYSTEM
• FEATURES OF EDC SYSTEM
• REGULATORY REQUIREMENTS
• ADVANTAGES
• STREAMLINING DATA COLLECTION AND
MANAGEMENT
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3. INTRODUCTION
• An electronic data collection (EDC) system is a computerized system designed
to collect clinical data in electronic format for use mainly in clinical research.
• EDC software replaces the traditional and manual process of managing clinical
trial data with an electronic system.
• EDC software streamlines the collection, review, and processing of clinical trial
data.
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4. HISTORY
• EDC started out in the 1990s as ‘remote data capture’ (RDC),
which was a way for patient data to be recorded electronically
at clinical study sites.
• These clinical systems have become more sophisticated, and
other computer and web-based systems such as electronic
case report forms (eCRFs) and patient-reported outcome
(PRO) systems have come into play.
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5. USERS OF EDC SYSTEM
There are three primary category of EDC users
Sites
Sponsor
CRO ( Contract research organisation)
• Sites – A site refers to the entity that coordinates and collects
data from the clinical trial patients, or subjects usually a
hospital or clinic. In sites investigator and physician is
responsible for the Patient care and patient data reviewing and
electronically signing the data .
• Sponsor – The sponsor of a clinical trial is the organization that
“owns” the trial.
• CRO – A CRO, or contract research organization, is an entity
that contracts with Sponsors to facilitate the planning and
conduct of a clinical trial.
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6. CONTENTS OF EDC SYSTEM
A graphical user interface component for data entry
A validation component to check user data
Reporting tool for analysis of the collected data.
Now a days cloud computing EDC system is used. Which
means ones need a computer and a browser to access the
tool.
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7. FEATURES OF EDC SYSTEM
• Appropriate forms for data collection
• User authorization and audit trail controls
• Data validation controls
• Provide streamlined communication between monitors, data
managers, and coordinators.
• Easily accessible tools to export patient data
• Meet all the regulatory compliance.
REGULATORY REQUIRMENT FOR EDC SYSTEM:
EDC systems must meet regulatory requirements of United States
part 11 of Title 21 of the Code of Federal Regulations; and
Electronic Records; Electronic Signatures (21 CFR Part 11).
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8. ADVANTAGES OF EDC SYSTEM
• An EDC system provides seamless data collection compared to
conventional paper-based data collection.
• In cloud-based modern systems, clinical sites can access the
EDC system from any computer and enter data quickly and
easily. It is not possible in Paper based documentation.
• Data managers can easily review the data entered in the
system and issue queries to sites to solve discrepancies.
• In cloud-based modern system EDC accelerates the data
cleaning process.
• An EDC tool guarantees solid data authenticity, integrity, and
security.
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9. STREAMLINING DATA COLLECTION
AND MANAGEMENT
• Streamlining data collection process means that you can put
systems in place where you are alerted to data that is
irregular, rather than having to search for it yourself.
• it saves time and resources by automatically removing pre-
determined files that are unnecessary and cleaning out
databases.
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10. Data management is the process of ingesting, storing, organizing,
and maintaining the data created and collected by an
organization.
• There are 5 Data management activities which includes
1. Data security
2. Data migration
3. Data review and Maintenance
4. Data analytics and Reporting
5. Data extraction
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11. REFERENCE
• https://www.fastman.com/news-events/why-should-
you-streamline-data-management-activities
• https://www.clinvigilant.com/blog/electronic-data-
capture/
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12. Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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