RTSM Extract Mapping
Introduction
Data objects (e.g. visits, regions, dispensing units) in RTSM data extracts are mapped to corresponding objects in 4C Supply® using a key mapping. There is one key mapping per study, which is managed via the RTSM Extract Mapping page.
Automatic key mapping is applied the first time an RTSM extract is loaded to a scenario. In automatic key mapping management, an algorithm matches unmapped objects to corresponding objects in the 4C Supply® scenario specification. If updates are required they must be made manually via the RTSM Extract Mapping page.
Note: When the system cannot automatically map an object it will show MAPPING ERROR on the RTSM Extract Mapping. This highlights that it has not been mapped and will not be considered in the forecast. A warning will also be displayed in the RTSM Extract Logs to prompt the user define the mapping manually for this entry.
Navigating the RTSM Key Mapping Tabs
Mapping Interface
The mapping process requires users to match 4C Specification objects to RTSM Extract objects. The RTSM Extract objects are divided into ten tabs:
Site Groups
Patient Visits
Depots
Regions
Kit Types
Treatment Arms
Cohorts
Titration Levels
Patient Statuses
Kit Statuses
Updating mapping values
In each tab, the RTSM object is displayed on the left and the 4C Supply® object is displayed on the right.
If a single RTSM object’s mapping needs to be updated, the 4C object can simply be selected from the dropdown in the ‘Value’ column on the right hand side.
If multiple RTSM objects need to be updated to a single 4C object, then the Bulk Update Mapping tool is best. Follow these steps to make a bulk change:
Clicking on the Bulk Update Mapping button will enter a selection mode.
Select the RTSM object to change using the check boxes on the left, or select all values by using the checkbox in the header bar.
Select the 4C object from the dropdown in the header bar, then select Apply Mapping.
Manual Mapping
The mapping must be complete to ensure that the extract data is correctly considered in the forecast. This may also require updating the specification to bring it into better alignment with the extract data. If changes are made to the specification they must be saved and re-interpreted before they can be mapped.
For patient data, it is essential that any data impacting dosing is mapped in full. For instance, if the RTSM Extract contains Dose Level information but the 4C specification does not include it, the Dose Level information should be added to the specification so that the system can determine which path an actual patient will take through the Visit Actions table.
Similarly, if the RTSM references a dropout visit, then this must be present in the 4C specification so that the system knows to drop any patients at that visit from the forecast.
It is acceptable to map multiple RTSM objects to a single 4C Supply® object. For example, if site groups in the RTSM Extract take the form of ‘USA_Low’ and ‘USA_High’ but the 4C Specification only includes one USA site group.
When the system cannot automatically map an object it will show as MAPPING ERROR on the RTSM Extract Mapping page to highlight that it has not been mapped and will not be considered in the forecast. When editing these rows in the RTSM Extract Mapping they will appear blank. If there is no appropriate 4C object to map to or if the object should be ignored, there are two options:
Not Mapped
Setting an RTSM object as ‘Not Mapped’ means that it will not be considered in the forecast. Updating mapping from MAPPING ERROR to ‘Not Mapped’ will not change the outcome of the forecast.
Ignored
Setting an RTSM object as ‘Ignored' will actively drop any data connected to this object. This object and items that reference it will be ignored by the forecast.
See the examples below for more information.
Examples of using Not Mapped vs. Ignored
The RTSM Extract contains cohort information for each patient but the 4C Specification does not reference cohorts.
The key mapping for cohorts can be set to Not Mapped. The patients will be included in the forecast and the unmapped object will not have any influence since the 4C specification does not reference this data.
If the key mapping for a cohort is set to Ignored all patients with the ignored cohort object will be dropped from the forecast. This may be desirable if a specific cohort should not be included in the forecast.
The RTSM Extract contains cohort information for each patient and the 4C Specification also references cohorts.
The key mapping for cohorts should be mapped in full to ensure no patients are lost.
A Not Mapped object will mean that the system does not know where to place the patient in relation to the visit actions tied to a cohort. If there are any visit actions that do not reference a cohort (such as screening) then patients will be recognized but only as far as this visit.
If the key mapping for a cohort is set to Ignored all patients with the ignored cohort object will be dropped from the forecast.
Applying Key Mapping Updates
Once changes to key mapping are saved, the extract must be reloaded in order for it to be applied. Once key mapping is complete and the extract has been reloaded, the actuals data that has been loaded is displayed in Inputs > RTSM Extract Data.
Label Group-Lot Mapping
If a specification uses label groups, the actual lots in an RTSM extract will need to be mapped to these label groups via the Inventory Summary on the RTSM Extract Data page. This is a separate step to key mapping but must be completed prior to forecasting.
Site Groups
Displays the mapping of region/enrollment group combinations in the RTSM data extract to site groups in the 4C Supply® scenario specification.
If changes are made to the regions and/or enrollment groups in the RTSM, corresponding changes must be made in the 4C Supply® scenario specification.
Patient Visits
Displays the mapping of patient visits in the RTSM data extract to visit codes in the 4C Supply® scenario specification. If changes are made to the visits in the RTSM, corresponding changes must be made in the 4C Supply® scenario specification.
If a visit is renamed in the RTSM, but no corresponding key mapping update is made (automatically or manually), a forecast calculation error with the following message may be shown:
'NoneType' object has no attribute 'visit_date'
Depots
Displays the mapping of depots in the RTSM data extract to depot codes in the 4C Supply® scenario specification. If changes are made to the depots in the RTSM, corresponding changes must be made in the 4C Supply® scenario specification.
Regions
Displays the mapping of countries in the RTSM data extract to region codes in the 4C Supply® scenario specification. If changes are made to the region in the RTSM, corresponding changes must be made in the 4C Supply® scenario specification.
In most RTSM systems, sites are associated with countries, while in 4C Supply® sites are associated with regions. If RTSM data extracts are used and sites are associated with countries in the RTSM, it should be specified in the 4C Supply® scenario specification that a study occurs e.g. in regions USA, JPN, FRA, and GER rather than specifying that a study occurs in North America, Asia and Europe.
Kit Types
Displays the mapping of kit types in the RTSM data extract to dispensing unit codes in the 4C Supply® scenario specification. If changes are made to the kit types in the RTSM, corresponding changes must be made in the 4C Supply® scenario specification.
Treatment Arms
Displays the mapping of treatment arms in the RTSM data extract to treatment arms in the 4C Supply® scenario specification. If changes are made to the treatment arms in the RTSM, corresponding changes must be made in the 4C Supply® scenario specification.
If visit action randomize is used to define treatment arms in the 4C Supply® scenario specification, then the mapping of treatment arms in the RTSM data extract occurs to these treatment arms.
Cohorts
Displays the mapping of cohorts in the RTSM data extract to cohort codes in the 4C Supply® scenario specification. If changes are made to the cohorts in the RTSM, corresponding changes must be made in the 4C Supply® scenario specification.
Titration Levels
Displays the mapping of titration levels in the RTSM data extract to titration levels in the 4C Supply® scenario specification. If changes are made to the titration levels in the RTSM, corresponding changes must be made in the 4C Supply® scenario specification.
If visit action titration is used to define titration levels in the 4C Supply® scenario specification, then mapping of titration levels in the RTSM data extract occurs to these titration levels (dose levels).
Patient Statuses
Displays the mapping of patient statuses in the RTSM data extract to patient statuses in 4C Supply®. If changes are made to patient statuses in the RTSM, these must be considered in the key mapping.
Note: Patient statuses are not specified in the 4C Supply® scenario specification. Instead, a standard procedure is used for patient status management in 4C Supply®.
Kit Statuses
Displays the mapping of kit statuses in the RTSM data extract to kit statuses in 4C Supply®. If changes are made to kit statuses in the RTSM, these must be considered in the key mapping.
Note: Kit statuses are not specified in the 4C Supply® scenario specification. Instead, a standard procedure is used for kit status management in 4C Supply®.
Custom Logic for Action Mapping
Certain study designs and RTSM concepts (e.g. collectible data) cannot be mapped between RTSM data extracts and 4C Supply® models using the standard procedure. In some of these cases, custom logic for action mapping can be applied to achieve accurate mapping. 4G Clinical will determine when custom logic for action mapping is needed and generate the mapping script during the study setup process.