Electronic Data Capture (EDC) Systems: Streamlining Data Collection
- 1. Welcome ELECTRONIC DATA CAPTURE (EDC) SYSTEM: STREAMLINING DATA COLLECTION Kajal Murlidhar Gohane M.Sc. MICROBIOLOGY Student ID : 138/072023 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1
- 2. Index • INTRODUCTION • COMPONENTS OF EDC SYSTEM • HOW EDC SYSTEM WORK ? • COMMON TYPE OF DATA IN THE EDC • EXAMPLE OF EDC SYSTEM • USE CASES FOR EDC IN CLINICAL TRIAL • BEST PRACTICES FOR STREAMLINING CLINICAL TRIALS WITH EDC • FEATURE OF EDC SYSTEM • BENEFITS OF EDC SYSTEM • LIMITATION OF EDC SYSTEM • CONCLUSION 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 2
- 3. INTRODUCTION Electronic data capture (EDC) is software that stores patient data collected during clinical trials. EDC systems are also used to document and manage data in clinical research studies. The technology replaces traditional, paper-based data collection methods and seeks to reduce clinical trial and drug development timelines and costs. 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 3 Vendor supported EDC System Open source EDC System Hybrid EDC System Cloud Based EDC System Custom EDC System Web Based EDC System Types of EDC System
- 4. COMPONENTS OF EDC 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 4 Graphical User Interface Validation Component Reporting Tool Paper Transcription Direct Data Entry Automatic Transmission Components of EDC
- 5. How EDC system Work ? 5 www.clinosol.com | follow us on social media @clinosolresearch 07/19/2023 1. DATA COLLECTION Data is captured electronically during the clinical visit 2.VALIDATION Before the study starts, the EDC system is tested and verified for adequate functionality and accuracy according to stated validation requirements. 3. QUALITY CONTROL It is used to ensure data accuracy. 4. DATA CLEANING In this the error in the data is check and controlled to avoid inaccuracy in the data.
- 6. COMMON TYPES OF DATA IN THE EDC 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 6 Measurements such as blood pressure, weight, body temperature Symptoms and disease status as reported by the patient or healthcare professional Symptoms or health endpoints collected directly from connected/wearable devices Clinical interpretations of a scan or test Resolution of a symptom or sign
- 7. EXAMPLE OF EDC SYSTEM 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 7 OpenClinica Medrio ECD RED cap Oracle Clinical Castor EDC Rave by Medidata Inform by Oracle Oracle RDC
- 8. USE CASES FOR EDC IN CLINICAL TRIAL 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 8 Sponsors - Organizations sponsoring clinical trials use EDC to optimize and streamline data collection, both in single trials and to integrate data collected across multiple studies. CROs - CROs, or contract research organizations, are often tasked with certain key operations in conducting trials (or conducting the trial in its entirety), and thus commonly use EDC systems. Sites - Sites refer to clinics, research hospitals, or other sites from which on-site clinical trials are conducted. Patients - Patients may also interact with EDC systems, but usually indirectly via ePRO (electronic patient-reported outcome) platforms or surveys that may be connected to the EDC
- 9. Best Practices for Streamlining Clinical Trials with EDC 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 9 • Choose the Right EDC System Choose • Train Personnel on EDC Train • Standardize Data Collection Standardize • Monitor Data Quality Monitor • Ensure Data Security Ensure • Use a Centralized Database Use • Conduct Regular System Maintenance Conduct • Regulatory compliance Ensure • Provide technical support Support • Evaluate the EDC system Evaluate
- 10. FEATURE OF EDC SYSTEM 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 10 Data entry and export Query Management Data cleaning eCRF Designer Report customized and integration Cloud functionalities Remote data verification Software integration Data Validation Data back up
- 11. eCRF DESIGNER • An electronic case report form (eCRF) is a digital version of the traditional paper-based case report form used in clinical trials. • Used by clinical research coordinators and investigators to collect and record data on each study participant. • Edit check can be programmed help prevent invalid data being interred. • eCRFs are saved in a library and used across multiple protocols to eliminate form repetition. DATA ENTRY • In this the protocol set up in the system • The collected data is entered in the system in the appropriate forms by the site coordinator 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 11
- 12. EDC facilitates communication between coordinators, data managers, and monitors. They offer both the ability to manually add queries and auto-generated queries. Before the database can be locked, all queries must be answered and resolved by various roles. 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 12 QUERY MANAGEMENT DATA EXPORT There are easily accessible exports in EDC to extract patient data. information can be entered or imported from other sources including connected ePRO devices, patient databases, EHRs, and spreadsheets. Similarly, EDC often provides a variety of data export formats and includes built-in reporting features to make analyses easier and present information about the trial's development
- 13. BENEFITS OF EDC 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 13 Improve Data Quality Reduced Data Entry Time Enhanced Data Security Remote Data Collection Real-time Data Collection Faster Access To Data Real Time Access To Centralized Data Better Data Quality And Accuracy Better Collaboration Reduced Risk Of Data Loss Increased Patient Safety Accessibility And Availability Operation Efficiency
- 14. LIMITATION OF EDC SYSTEM 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 14 For data submission using EDC software, site training is required. At the point of entry, it does not permit central data cleansing. Systems for monitoring browser compatibility and database user access are required to assure secure data access. To allow system use at trial sites, eCRF design and submission convention approvals are necessary.
- 15. CONCLUSION 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 15 By offering a precise and effective mechanism for data collection and management, EDC has changed the clinical trial process. Greater data quality, shorter data entry times, greater data security, remote data collecting, and real-time data monitoring are some of the advantages of EDC in clinical trials. Clinical trials can be simplified for increased accuracy and efficiency by adhering to best practices include selecting the appropriate EDC system, standardizing data collecting, monitoring data quality, ensuring data security, using a centralized database, and performing routine system maintenance. Researchers must stay current on best practices and technological improvements as the use of electronic data capture in clinical trials increases in order to ensure that the highest quality data is gathered for the benefit of patients and the field.
- 16. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 info@clinosol.com 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 16