Introduction

The RTSM Extract Loader is used to load actual study data into 4C Supply®. RTSM Extract data can be transmitted to 4C Supply from different sources but once the integration has been established the data will show up as a daily transmission on this page. Loading an extract enables the system to consider actual sites, patients, and inventory when running a forecast.

The RTSM Extract Loader

An RTSM extract can be loaded by selecting the appropriate dataset from the screen above. The Select Raw Extract dropdown will populate with all available extracts sorted chronologically (newest first). Once the required extract has been selected, the Extract button will initiate the load process. This creates a log similar to the SMART Editor interpreter or the forecast calculation logs and is populated with info, warning, and error messages.

There are three pre-requisites for an RTSM Extract to be loaded and used as part of a forecast:

1. Integration Setup: This is configured by the FSL team and enables the transmission of data from Prancer or from a third-party RTSM to 4C Supply®.

2. Study and Specification: A study using the same study code and an interpreted specification must be available in 4C to match the real objects to specified objects. Matching these objects is referred to as key mapping.

3. Key Mapping: A key mapping file is automatically created whenever an extract is loaded for the first time. The system will make some assumptions and use some default mapping values to create the initial mapping. This mapping must be reviewed and updated prior to forecasting to ensure objects are considered as intended.

Integration Setup

The integration setup must be configured by an FSL. If the RTSM in use is Prancer or if another study has been set up using a previously established source then the integration configuration should be straightforward If the integration will use a new third-party source it will take more time and more information will be needed. If you wish to request an integration with Prancer RTSM, please contact 4csupply@4gclinical.com and include the study code and the name of the study/scenario you would like us to use for the initial key mapping.

Using an Established Source

If the integration connects 4C Supply and Prancer, or if the integration connects with a previously established third-party RTSM and 4C Supply, the FSL should be able to configure the connection with minimal details. The integration will be set up and tested in an internal environment before configuring the production environment.

Using a New Source

If the integration connects 4C Supply to a third-party source that has not been previously configured, then the data must be correctly formatted in adherence with the 4C Supply Actuals Integration Specification and transmitted according to a data transfer specification.

Scenario Specification

There must be a study that uses the same study code and a specification available in 4C Supply for the RTSM Extract data to be appropriately integrated into the study model. Whatever data is present in the extract should align with the specification in 4C Supply in order for it to be used. For example:

If the 4C specification introduces dose levels for all patients at Visit 3, then the system will expect to see dose-level data included in each patient’s Visit 3 record.

Conversely, if the extract data contains information about dose level in patient records but the specification does not include dose level information, it must be added to the 4C specification to enable the system to correctly process the patient data.

When loading an extract, the user must specify which study and scenario to use. If the user has not already chosen which study and scenario to work in from either Home or Select Study/Scenario, then they can select this info from the RTSM Extract Loader using the Select Study and Select Scenario dropdown menus. Whatever scenario is used, it must have been interpreted in the SMART Editor first.

Note: If the 4C specification is updated after the initial setup the key mapping should be updated accordingly (see the next section). When key mapping is updated the extract must be re-loaded to apply the changes.

Example of RTSM visits are mapped to visits in a 4C specification

Key Mapping

Key Mapping allows 4C to relate data in the RTSM extract to the data in the specification. There is one key mapping per study and the current version is referenced whenever an extract is loaded. Key mapping is mostly a manual process, but the system will try to make some connections automatically.

Automatic Key Mapping

Whenever an integration is set up, the system will apply default mapping in order to complete the first extract load. Default mapping applies simple logic to match object pairs. For instance, if the RTSM Extract contains visit numbers like ‘1, 2, 3,…’ and the specification uses ‘V1, V2, V3,…’ the system should match these automatically. For objects that are not commonly defined in the specification, like kit status and patient status, there are default pairs applied to all studies (e.g., “Active” is mapped to “Active”).

Manual Key Mapping

The default mapping will be updated by the FSL that sets up the integration to confirm the integration is working as expected. It is the responsibility of the user to review this and finalize the mapping to ensure the object pairs are appropriate for their study. Key mapping can be reviewed and updated from Inputs > RTSM Extract Mapping.

If changes are made to the key mapping, the extract must be reloaded in order for it to be applied. When the extract is loaded the updated key mapping will be used and this will be reflected in the info/warning/error messages on the RTSM Extract Loader log. The aim of key mapping is to resolve any warnings or errors that are not acceptable.

Note: If you are aware of a study being updated in the RTSM, e.g., Additional Visits, Removal of Dose Levels, New Dispensing Units, the 4C Supply specification and Key Mapping must be updated. Reinterpret the specification and load the latest actuals file to complete this update. If you cannot see the expected values available for mapping after doing so, contact 4csupply@4gclinical.com with the details.

The RTSM Extract Mapping page is used to map extract objects to the specification

Loading an Extract

Once the study and scenario are selected, any available extracts should appear in chronological order in the Select Raw Extract dropdown (newest first).

Selecting Extract will load the data into the system and produce a log similar to the interpreter. Successful data extract events are captured in blue info messages, while orange warning messages indicate a potential misalignment between the data source and the specification. Red error messages indicate an object could not be mapped. As with all logs in 4C Supply, it is important to review all warning and error messages to confirm the implications are acceptable before proceeding with the forecast.

Example of a complete RTSM Extract load log

Once the extract load is complete, all extract data will be displayed in Inputs > RTSM Extract Data under three tabs, Study Sites, Patient Summary, and Inventory Summary. These three tabs display the extract data that has been loaded, i.e., with key mapping applied. This data will be considered when running a forecast.

The RTSM Extract Data tab shows the extract data in its ‘raw’ form, i.e., the file as it was transmitted to 4C Supply, without key mapping. This tab can be used to review the unaltered data for troubleshooting purposes.

Example of the Patient Summary in RTSM Extract Data