Web Based Data Capture EDC & RDC

Presented by:

PATHAN AZHER KHAN

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.

1. Login2. Filter Patients3. Enter data

2. Filter Patients

List of studies

Site List

Data Forms

Data Evaluation

Data Evaluation

Screening

Edit Checks or Updates

Example Edit Checks on Systolic Blood Pressure field

Vital Signs Form

List of Sponsors

Study details or Data collected

Validation

Subject Lab

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

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.

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