SAP Intelligent Clinical Supply Management introduces three completely new master data objects that are described in the following section.
Study Master
- Starting point and key component for the whole end-to-end process in SAP Intelligent Clinical Supply Management.
- Allows the configuration and management of clinical studies.
- For a study, you can specify the groups of clinical sites (site groups) that will be involved, the kit types that will be dispensed to subjects, and the basic study time line, including the earliest FSFV date.
- For regular studies, in contrast to lean studies, you then define one or more scenarios that can be compared for planning purposes. At scenario level, you define:
- Randomization groups
- Treatment groups, including planned enrollment per treatment group across all site groups, and the enrollment planning and recalculation methods per site group for the treatment group.
- Treatments
- Treatment schedules
- Site group-specific settings such as offsets to the FSFV date, end of demand dates, site seeding, kit type replacement demand, and kit type switch demand.
- The Studies are created in the Manage Studies app in the Study Cloud BTP system and linked to SAP S/4HANA via a real-time interface. A description of this interface can be found in the lessons 1.1 and 2.1.
Note
For more detailed insights, refer to the official description of Managing Trials.Medication List
- Each study requires a medication list that contains one or more medication number sets. These numbers are assigned to process or purchase orders and are printed on the labels of serialized treatment kits during packaging to uniquely identify each kit.
- A medication list is created in one of the following ways:
- With uploaded numbers from CSV file
- With generated numbers provided by SAP Advanced Track and Trace for Pharmaceuticals
- Generated via SAP Intelligent Clinical Supply Management
- All medication number sets require the approval of a user with the corresponding authorization, who may not be the same user who generated or uploaded the number set. Before receiving the status Approved, medication number sets have the status In Review.
Note
For more detailed insights, refer to the official description of Managing Supply.Shelf Life Data
- Shelf life data sets are sets of regulatory information applicable to a primary pack (PP) material (or where used, a flavor ID) in combination with a specific study, or with a pool ID in the case of pooled materials.
- A shelf life data set typically includes the following information:
- Total (technical) shelf life of the primary pack (PP) material or the reference PP material
- Indicator showing whether a shelf life is required
- Filed shelf lives for specific countries/regions - filed with the regulatory authority
- Planned approval dates for the filed shelf lives
- Indicator that a PP material is approved for use in a specific country/region
- Approved shelf life for the PP material and for a specific country/region
- Planned shelf life
- IB flag, which indicates that only information in the investigator's brochure is relevant
- Auto-approval information (limited or unlimited), with a maximum shelf life
- Packaging-relevant shelf life – see Packaging-Relevant Shelf Life for details of how it's calculated.
- The information can
- be entered and edited manually in the app Manage Shelf Life Data,
- via integration with a Regulatory Information System (RIMS)
- or by a combination of both methods
Note
For more detailed insights, refer to the official description of Managing Supply.