Read more on Signature Status here.

Overview

Only Data Specialist and Investigator can sign data.

Visit CRF is the smallest unit which can be signed. Conditions for a visit CRF to be signed are:

Visit CRF has one of the following statuses:
- Data Entry Status as Completed
- Data Entry Status Skipped
- General Status as Removed
- General Status as Auto-removed
Signature Status is 'Not Signed'
No DN query or failed validation check which has not been closed (recommended not required)

Contents:

Signing data from Enter Data

From Enter Data, only users with Data Specialist and Investigator roles can sign visits and subjects.

Sign visit CRF

Select visit CRF qualified for signing
Select 'Sign' to sign visit CRF
Read statement and input current password
Click on 'Sign' or hit enter to finish

After finishing, visit CRF will have signature status as signed.

Sign visit

Select visit qualified for signing (all visit CRFs must qualify)
Select 'Sign' to sign visit
Read statement and input current password
Click on 'Sign' or hit enter to finish

After finishing, visit will have signature status as signed.

Sign in batch in Enter Data Screen

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

Automatic removal of signature status upon change of data

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

Actions leading to removal of signature status includes:

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

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