Scientific & systematic collection of data for clinical study is called as Clinical Data Management- Clinical Data Management-Web Based Data Capture EDC & RDC , Oracle SAS Office software UW Catalyst data collection (University of Washington) REDCAP (Research electronic data capture) OPENCLINICA STUDY TRAX

1. Web Based Data Capture EDC & RDC
Presented by:
Pristyn Research Solutions
www.pristynresearch.com

2. SOFTWARE USED
1. Oracle
2. SAS
3. Office software
4. UW Catalyst data collection (University of Washington)
5. REDCAP (Research electronic data capture)
6. OPENCLINICA
7. STUDY TRAX
8. etc.

7. 1. Login
2. Filter Patients
3. Enter data

9. 2. Filter Patients

10. List of studies

11. Site List

12. Data Forms

13. Data Evaluation

14. Data Evaluation

15. Screening

16. Edit Checks or Updates

17. Example Edit Checks on Systolic Blood Pressure field

18. Vital Signs Form

19. List of Sponsors

20. Study details or Data collected

21. Validation
Subject Lab

22. Most clinical research lab data is electronically entered directly into a
computer, with the electronic data file serving as the source data.

23. Clinical research data captured directly from the subject can be entered in two
steps via (1) paper case report form to (2) computerization, or in one step (1a)
directly into the computer.

29. Difference between e-process and paper process
Paper CRF:
Electronic data collection:
protocol CRF Database Data evaluation DB lock
Data Analysis
Data entry
Conduct the trial
protocol eCRF/ Database Data evaluation DB lock Data Analysis
Data entry Conduct the trial