Source Data Validation

Overview

Source Data Validation (SDV) is the process in which user with monitor rights evaluate data entry results and whether data entry is accurate.

Visit CRF is the smallest unit which can have SDV status.

Conditions to verify a CRF depends on visit CRF:

SDV configuration of that visit CRF in visit definition must be 100% Required, Partial Required or Not Required, not Not Applicable
Visit must have 'Not verified' as status
Data entry status must be Completed or Skipped, not Locked
No DN query or Failed Validation Check (recommended not required)

We encourage users to conduct SDV before signing the data

Contents:

Verify data from Enter Data Page

From Enter Data Page, user with monitor rights can perform SDV for visit CRFs and visits

Verify visit CRF

Select CRF for SDV (user will be redirect to the visit CF dialogue to view inputted data)
Choose 'Verify' on the action bar

Once completed, the verified icon will appear on the status icon of visit CRF

Verify visit

Select visit whose visit CRFs qualifies for verification
Choose Verify on action bar

Once completed, the verified icon will appear on the status icon of that visit and visit CRFs.

Verify in batch in Enter Data Screen

User can verify visit CRFs or visit in batch via Batch Action in Enter Data page

Verify data from Source Data Validation Screen

Layout

SDV Screen summarizes all visit CRFs and subjects for verification

Change SDV Mode: Switch between visit CRFs or study subjects for SDV

Pagination: Pagination and navigation of search results

Filter: Used to filter information by criteria

SDV Table: Table with subjects on which SDV can be performed

With SDV by visit CRF, each row represents visit CRF's information as SDV status, study subject, visit, visit CRF and actions button
With SDV by visit CRF, each row represents each subject and their information

Verify data in View by Visit CRF Mode

In 'View by Visit CRF' user can verify visit CRFs.

Verify each visit CRFs

Select () corresponding to each target visit CRF

Verify multiple visit CRFs

Select visits CRFs
Select SDV All Checked

SDV data by study subject

This allows SDV of study subject whose visit CRFs qualify for verification

Verify each study subject

Select () corresponding to each target study subject

After completion, all qualified visit CRF of study subject will have SDV status as 'Verified'.

Verify multiple visit CRFs

Select study subjects
Select SDV All Checked

After completion, all qualified visit CRF of study subjects will have SDV status as 'Verified'.

Automatic removal of SDV upon change of data

Updates to data causes the SDV status of visit CRFs and visit will be removed. Visit CRFs and visits will return to 'Not Verified' status to ensure data quality.

Actions leading to removal of SDV status includes:

Edit data of a visit CRFs
Re-enter data for a skipped visit CRF
Recover visit CRFs, visit or study subject