Study Tile

The Study within the home page

Folder

A visit or ad hoc assessment. All assessments required per the procotol are within the visit folders

Ad Hoc Assessment

A repeatable log such as Medical History, Adverse Events, or Concomitant Medications -or- an assessment only needed in certain scenarios, such as an SAE.

Query

A query is raised on a specific datapoint by a Vial CRA or Data Manager when the data is not clear or a discrepancy is found.

Data Freeze

A soft lock of the data set by the data manager in preparation for a data lock. a data freeze is reversible if necessary.

Data Lock

A database lock of the system. All assessments must be query free and signed by the PI prior to a database lock.

Audit Log

The audit log is the trail of data. It shows when data is saved, the value that was submitted, and who submitted the data. If the data is changed, the audit log captures when the data was changed, who changed it, and the reason for the change.

The audit log is present for the subject details and specific visit data.

Target Date

The target date of visits is the date the visit should be completed based on the visit windows set by the protocol and the date the baseline visit was completed.

Form Status

The form statuses are:

These statuses indicate what state the particular assessments are in to easily identify where action is needed.

Visit Status

The Visit statuses are:

In progress visits mean that there is missing assessment data within the visit.

Missing Data

Missing data means that an assessment was not fully completed. For example, this could be an AE that needs to be assessed by an investigator, or a field that was inadvertently missed. Either way, the system will show in red that data is missing.

Inactive Data

Inactive data is data point that needs to be removed as a considered data point. You can inactivate a data point after the form is submitted for the first time. Inactivated data can always be reactivated.

eSource*

eSource is a data type used to signify the data was captured in the EDC directly during the visit. If using a tablet, eSource is the default data type. The eSource data type informs the CRAs that the audit trail should also be monitored, to ensure the user capturing the data was delegated to do so, and the timing of the data collection was in accordance with the protocol.

eCRF*

eCRF is a data type used to signify the source data was first collected on paper or a different system, and is being transcribed into the Vial EDC. The eCRF data type informs the monitor that Primary Source exists elsewhere, and should be reviewed to verify the data was transcribed correctly.