Enter Data into Visit

Overview

Data Entry for a visit begins when a visit is scheduled and ends when all CRFs in that visit has finished data entry. 
Data entry for each visit CRF will be marked as completed once data entry status is 'Completed' or 'Skipped'.

Inputting Data for a Visit CRF

Access the dialogue to input Data for a Visit CRF

Two main methods are:

Method 1: Data entry for visit

1. Access visit via the Subject Matrix page, via list of visits of subject or after being redirected after scheduling visit
2. Choose visit CRF in visit

Method 2: Access via Task Summary

1. Access Task Summary of site, select the subject for data entry
2. Access visit CRFs which requires data of scheduled visit to be entered

Layout of Visit CRF Data Entry Page

Visit CRF Data Entry Page is a child of Enter Data Page

This page has the following components

1. Header with basic information of CRF, version name, study subject ID. Upon click, the header expands to provide a summary of number of DN in current visit CRF
2. Navigation among sections in visit CRF
   1. Tab navigation
   2. Select box navigation
3. Main data entry screen
4. Action buttons
   1. Action buttons with actions which can be taken with visit CRF at the moment (Remove, Restore, Skip, Sign, Verify, Clear, Print, Reassign)
   2. Data Entry action buttons (Next, Save, Save and Mark Complete)

Layout of a data field in visit CRF

1. Data field to be entered
   1. There are multiple types of data fields such as text, textarea, radio, selectbox, date picker
   2. In certain cases, units may appear after the data field
2. Mark the data field as required
3. Button to create discrepancy note of current data field

Data Entry Basic Rules

• Must enter all required data fields (marked *)
• Must enter data in the format required in protocol
• When there is no data that matches the required format, must create DN Failed Validation Check. Monitor will then review if this data matches the protocol and close DN if the data cis correct
• Non-qualified data (this does not includes case where there is no data but data entry is required) will be automatically marked as DN Failed Validation after saving data 2 times without updating the data
• Can only save the data after passing Edit Check
• Save and Mark Complete to finish data entry

Edit Check

Edit Check is the validation of data. Upon save, the system will notify the user and mark data which does not comply with study protocol. 

To pass Edit Check, user needs to create DN of Failed Validatin Check type of mark data for revision. Failed Validation Check will be automatically created if data is saved twice without change

Updating the data of a Completed CRF

With visits which have finished data entry, CheckPad restricts updating data. 

For data with DN, updating data is allowed. For data without DN, the reason requires creating Reason for Change to update data.

Skipping CRFs without data

CheckPad allows user to mark CRFs as 'Skipped' if there is no data.

Complete data entry for visit

Completed or skipped visit

Once all visit CRFs are completed or skipped, the status of all visit CRFs will be aggregated to make the status of the current visit

• When all visit CRFs with data have 'Completed' as status (at minimum 1) and all visit CRFs without data have 'Skipped' as status, data entry for visit is considered complete and has status 'Completed'
• If a visit does not have any data, all visit CRFs and the visit itself will be skipped and has 'Skipped' as status

Mark visit as completed

Can mark visit as completed if all visit CRFs for visit are considered complete and has status 'Completed'

1. Select visit
2. Choose 'Complete' to skip uncompleted visit CRF → Mark visit as completed
3. Choose 'Yes' to confirm action

If a visit does not have any data, all visit CRFs and the visit itself will be skipped and has 'Skipped' as status

Mark visit as skipped

Can mark visit as completed if all visit CRFs for visit do not have data. 

1. Select visit
2. Choose 'Skip' to skip uncompleted visit CRF → Mark visit as skipped
3. Choose 'Yes' to confirm action 

All visit CRFs will be skipped.