Create Drug Reconciliation forms

As part of the drug reconciliation process, site users can now generate purpose-built drug reconciliation forms, which can be designed with a new self-populating type of field.

Before you work with this feature

As part of drug reconciliation, the new purpose-built drug reconciliation forms aim to replace drug order forms. Introduced in conjunction with the new instructional text field, drug reconciliation forms are more customizable and can be designed as part of the standard form design process. For more information on the new instructional text field, see Add instructional text.

To design drug reconciliation forms, study designers must have the Design Supplies and Dispensation permission assigned.

Details for study designers

As a study designer, you can now add a new question type to your Drug Reconciliation form called Existing Data. This new type of question uses existing study data to reduce the number of fields a Clinical Research Associate (CRA) needs to complete when using the form to perform drug reconciliation. Existing data fields are only available to drug reconciliation forms.

Drug reconciliation forms have a three-section structure by default, which you can customize according to your needs. These are:

• A flat section, containing study, depot, site, and user details.
• A repeating section, containing self-populating fields related to kit information.
• Another flat section, with target depot and form information fields.

Details for sponsor users

As part of the drug reconciliation process, CRAs can now access the drug reconciliation form in the Shipments tab in the study's Supplies panel. Once kits are marked for destruction, CRAs can select which kits to perform reconciliation for in the site inventory, generate and complete the form, and use it according to the workflow of the study.

You can find additional information in the Information for CRO and Sponsor Users guide after the Release Assessment Environment (RAE) upgrade.

Impact on reports

• Drug reconciliation forms are reflected in the Study Design report through a three-section layout:
  1. Questions before the table
  2. Questions inside the table
  3. Questions after the table
• Drug reconciliation forms are also reflected in the Annotated CRF report.

Note:

drug reconciliation forms will not be included in Oracle Clinical One Analytics.

Already working in a live study?

To start working with drug reconciliation forms, you must update and go through the entire study versioning process, since Advanced Study Versioning (ASV) is not supported. To apply your changes, update in a draft study version, approve it and assign it to the impacted sites in the appropriate modes.

Note:

existing drug order forms which have been used for drug reconciliation will not be affected should a study designer create a drug reconciliation form.