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Sync subject-specific factor data to EDC

The subject-specific factor is a value or a piece of information that determines the drug dispensation for the subject. Factors like the subject's gender, date of birth, and so on are unlikely to change throughout the study. However, such factors as the drug dosing or cohort can fluctuate and be assigned automatically upon randomization or selected manually if there is a need for change during study conduct.

All subject data entered in IWRS, and in this case their specific factors, must be properly reflected on their case report forms (CRFs) in EDC. To achieve prompt data alignment, you can manually sync the data whenever needed—when some changes are introduced, or in other cases.

An example of this feature implementation can be when the subject factor is originally selected for a subject in IWRS, it was not mapped to any item (question) on the CRF in EDC. Thus, this data is not reflected by any EDC form. Then a new item is added to capture the subject-specific factor, and now you can manually sync your IWRS factor data to EDC so that it lands in its intended CRF item.

To sync subject-specific factor data to EDC

  1. In the IWRS application header, select the SUBJECT tab.

  2. From Subject List that opens, select the needed site and subject.

    Selecting site and subject
    Figure 1. Selecting site and subject

  3. Under the Subject Information tab, from the workspace toolbar, select Sync Mapping Factor to EDC sync_facor_icon.png.

    Selecting to sync subject-specific factor value to EDC
    Figure 2. Selecting to sync subject-specific factor value to EDC

  4. In the Confirm dialog that appears, all the values that are to be synced to EDC are listed. Select confirm_button_white_red.png to proceed with data sync.

    Confirming subject factor value sync
    Figure 3. Confirming subject factor value sync

Upon confirmation, the factor data is synced to EDC as follows:

  • If the synced data differs from the existing data in the EDC CRF, the existing value is overwritten with the synced one. This change is reflected in the CRF audit and operation history in EDC.

  • If the synced data is the same as existing in the EDC CRF, no change is made to CRF data. Thus, no record of this sync attempt is made in CRF audit and operation history in EDC as redundant.

In this section:

In eClinical, a process of providing a subject with medication at a visit to a site during their treatment in the course of a clinical trial.

A group of subjects who share a set of specific factors (characteristics) that is first defined and composed, then studied or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific inclusion criteria.

A process during which subjects receive their random numbers and are assigned to different arms based on the randomization scheme.

A specialized document in a clinical trial designed to collect the subject data.

See also eCRF.

An eClinical application that is mainly used to collect and manage subject data during clinical trials. It integrates with the Study Designer (SD) application and uses preconfigured there case report forms (CRFs) to complete data collection and management. It also provides an audit trail, data alert, source data verification (SDV), payment management, adjudication, and other functions as well as supports data export according to the CDISC ODM standard.

Get to know all the possibilities of the app with the comprehensive EDC User Guide.