Monitoring is the work of checking that what sites entered is accurate, complete and ready for analysis. Datacapt gives you five separate tools for it, and they work at different levels of the eCRF. This article explains which is which, and points you at the guide for each.
š Prerequisite: Monitoring (Access) on your role, to open the dashboards. The actions themselves each need their own permission, named in the article that covers them.
Which one do you need?
You want to | Read |
Ask a site about a value they entered, or answer a query raised on your data | |
Have the platform raise queries for you, automatically | |
Record that a value could not be collected | |
Confirm a form has been checked, or that a value matches its source document | |
Freeze data so it cannot be changed | |
Set up your study's monitoring process | Follow data monitoring best practices |
Definitions
Data monitoring: reviewing and validating the data collected during a study, to make sure it is accurate, complete and reliable.
Data reviewer: the person doing that work. Usually a Clinical Research Associate, but any role with the right permissions can.
Query: a note attached to one data point, asking for it to be checked. A query is a threaded discussion, not a one-way flag.
Manual query: raised by a person during review.
Automated query: raised by the platform when a data validation rule fails.
Data validation: a rule you attach to a question in the eCRF Builder, which checks the answer as it is entered.
Missing data: a data point recorded as not collected, with a standard reason code, rather than left blank.
Data review: a stamp applied to a form, marking it as checked.
Source Data Verification (SDV): a stamp applied to a single answer, confirming it matches the original source document.
Lock: freezing data so it can no longer be changed.
Sign: an electronic signature on data, confirming the signer takes responsibility for it.
Each tool works at a different level
This is the part that causes the most confusion, so it is worth reading once before you start. In the eCRF, a visit is a section and a form is a sub-section.
Action | Applies to |
Query | One question, one at a time |
Missing data | One question, a form, or a whole visit |
Data review | A form |
SDV | One question |
Lock | A form, a visit, a whole eCRF, or several eCRFs at once |
Sign | A visit, a whole eCRF, or several eCRFs at once |
š” Tip: the level is why some actions have a bulk option and others do not. You can declare a whole visit as missing in one gesture, but you cannot raise one query across a whole visit: a query is a conversation about a single value, so it stays attached to that value.
The four monitoring dashboards
Go to eCRF > Monitoring. One permission, Monitoring (Access), opens all four tabs.
Tab | One row is | Answers |
Queries | One query | Which queries are open, where, and who spoke last |
Data Review | One subject's eCRF | How much of each subject's eCRF has been reviewed |
Source Data Verification | One question | Which values still need verifying against source |
Missing Data | One declaration | Every value recorded as missing, and where |
All four filter by center, and save that filter for next time. Each row has an eye icon that takes you straight to the data point, and a back control that returns you to the list, so you can work through a list without losing your place.
š” Tip: only the Queries tab has an Export button. If you need the other three out of the platform, they come through the full eCRF export instead, which carries queries and missing data on their own sheets. See Export eCRF data.
Not every study shows every option
Data review and SDV are off by default. They only appear once eCRF Review has been switched on in the study's settings. On a study without it, the Data Review and SDV tabs are absent and the review controls do not appear in the forms.
This is the single most common reason two people describe the same screen differently. If a colleague sees a control you do not, compare the studies before assuming something is broken. See Review forms and mark data as SDV for how to switch it on.
ā ļø Warning: nothing in Datacapt notifies a site automatically when a query is raised on their data. A site sees it when they next open the eCRF, where the top right of the screen reads 1 active query instead of No active queries. If your study needs email, someone has to build an Automation for it. Plan this before go-live, not after queries start sitting unanswered. See Create and Configure Automations.