What is Study Monitoring?

For a clinical trial (study) to be conducted according to the principals of ICH GCP (in Canada this is all studies performed under a Health Canada CTA) the study must be monitored. Study monitoring involves many tasks (see ICH-GCP for a complete list) but includes a review of completed CRFs to ensure that they are an accurate reflection of the study’s source documents. This process is known as source document verification (SDV). In studies where REDCap is considered to be an electronic CRF this means that REDCap’s data collection forms must be verified by comparing them to the source documents and then resolving any discrepancies (Query management).

Study Monitoring and REDCap

REDCap does not have a built-in monitoring role but it does have all the features necessary to review the study data, track monitoring progress, and manage data discrepancies as follows:

User Rights

Monitors are responsible for source document verification and query management. However the actual data content is the responsibility of site staff (primarily the investigator and designees). As such the monitor should be able to read electronic CRFs but not edit their content.

Form Status

REDCap’s form status may be set as part of the data entry process. This flag is intended for use by site staff and may only be modified by users with write access to the form. It can take the following values:

• Incomplete – data entry has started but the form is not yet complete

• Unverified – the form is complete but is awaiting review

• Complete – the form is complete

Record Locking

Selected users can lock and unlock records. Records that are locked cannot be edited without first being unlocked. If a study is using electronic signatures then unlocking a form also clears the signature associated with the form. Record locking can be used by the study monitor to track which forms have been monitored. The Locking Management Module helps facilitate this.

eSignatures

Although not strictly part of the monitoring process eSignatures can be used to signal the investigator’s review and approval of the study data. Unlocking a form to make changes will clear any signature associated with that form. eSignatures are not necessarily required to demonstrate accountability (as required by GCP). If the investigator is already signing the study’s source documents this may be adequate.

Data Quality Rules

REDCap’s data quality module allows the study team to implement data quality rules (edit checks). Typically these rules would be developed and used by data management staff. However they could also be developed for use by study monitors. (Traditionally monitoring and data management roles have some similarity/overlap).

Data Resolution Workflow

If configured during project setup (Additional Customizations) the monitor and other authorized personnel (such as a data manager) can raise queries and assign them to other project users (a coordinator) for resolution. These users can respond to queries and mark the data item as “verified”. Following additional review the monitor can close the query. When there are no longer any open queries on a form it can be locked by the monitor.

Process Overview

• Coordinator enters data

• When form entry is done coordinator sets form status to "complete"

• Monitor reviews form

• Monitor raises queries

• Coordinator responds to queries

• Monitor closes queries

• Monitor locks form

• PI applies eSignature to form (if required)

REDCap Configuration

The following configurations are required in REDCap.

Project Setup – Additional customizations

Enable Data Resolution Workflow

User Rights

We suggest that you create user roles for your study monitors and coordinators.

Coordinator Role

The coordinator will need to respond to queries that have been opened by the monitor. However if you also allow them to open queries they can use the query to annotate the data and add comments that may be useful to the monitor later. The coordinator should not be able to lock and unlock records as that will be performed by the monitor.

Monitor Role

The monitor must be able to open, close and respond to queries.

In a clinical trial the Investigator is responsible for data content and therefore the monitor (who is employed by the Sponsor) would not have write access to individual participant records. This can be achieved by setting the Data Entry Rights column appropriately.