Electronic Data Capture (EDC) Systems: Streamlining Data Collection

Electronic Data Capture (EDC) systems are software platforms designed to streamline and enhance the process of collecting, managing, and monitoring clinical trial data electronically. EDC systems replace traditional paper-based data collection methods, offering numerous advantages for clinical research. Here's how EDC systems streamline data collection in clinical trials

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 Components of EDC

5. How EDC system Work ? 5 www.clinosol.com | follow us on social media @clinosolresearch 07/19/2023

6. COMMON TYPES OF DATA IN THE EDC 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 6

7. EXAMPLE OF EDC SYSTEM 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 7

8. USE CASES FOR EDC IN CLINICAL TRIAL 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 8

9. Best Practices for Streamlining Clinical Trials with EDC 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 9

10. FEATURE OF EDC SYSTEM 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 10

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

14. LIMITATION OF EDC SYSTEM 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 14

15. CONCLUSION 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 15

16. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 [email protected] 07/19/2023 www.clinosol.com | follow us on social media @clinosolresearch 16