Exploring the Glossary of Technical Terms

Note

This lesson gives a description for commonly used technical terms in the clinical trials domain which have been used in this learning content for SAP Intelligent Clinical Supply Management.

A cartoon illustration depicts an open book with the title Glossary. A hand points to the text on the page, emphasizing the focus on locating a term. The book has a teal cover, with a yellow background.

blinding group: Group assigned to a kit type in a blinded study to identify which materials must be blinded together.
central depot: Intermediary location from where kit types are shipped to the distributing depots.
competitive enrollment: A specified group of site groups within a randomization group, called a competition group, has a common enrollment target. The site groups have a recalculation method that does not limit the enrollment period. Currently, only the three-month average method meets this requirement.
contact role: Role that a contact has in a study, such as Clinical Trial Manager or Supply Chain Planner.
depot buffer: One element of the do not transfer (DNT) lead time which is checked as part of the stock transport order (STO) validation. The depot buffer is given in days.
dispensing event: An event type representing site visits by subjects at which kit types are either administered at the site or handed out to be administered at home.
distributing depot: Location from where kit types are shipped to the sites. The demand forecast is mapped to this depot to enable replenishment planning.
distribution template: Model of the distribution network based on the defined supply route for each site group. A distribution template contains default values for the central and distributing depots, depot buffer, shipping lead time, and site buffer.
Do Not Ship: A time period relating to the required minimum remaining shelf life of a kit type, and used to group demands. For kit types that are handed out to be administered at home, the Do Not Ship time is derived from the length of the treatment period (the time span between two consecutive dispense events), the site buffer, and the shipping lead time. For kit types administered at the clinical site, the Do Not Ship time is calculated using the site administration period instead of the treatment period length.
dropout rate: Percentage of subjects who leave a treatment group, and therefore the study, at the end of a period.
end of demand date: The final date for which demand is generated for the site group, regardless of any potential additional visits.
enrollment curve: Graph that describes the progress of subject enrollment to a study. Enrollment curves are defined using a set of data points (percentage of enrollment period, percentage of subjects enrolled).
event: One of three event types: a dispensing event, a site seeding event, or an additional demand event. All events are associated with a demand quantity. Dispensing events represent visits in demand forecasting.
expiry date: The date beyond which a drug product can no longer be safely used. It's initially calculated based on the manufacturing date and the shelf life.
external identifier: Study identifier from an external source, such as a clinical trial registry (for example, EudraCT, DRKS, or ClinicalTrials.gov).
filed shelf life: A future product shelf life that has been submitted to regulatory authorities in a specific country/region. Often, the expected approval date is known.
flavor: Version of a material typically defined by product type, material-related characteristics, and batch-related characteristics. The use of flavors is optional but it reduces the proliferation of SAP materials. When flavors are used, each shelf life version applies to a specific combination of study and flavor ID. Multiple materials for which the same shelf life version applies can have the same flavor.
FSFV: First subject first visit.
kit type: Clinical finished good (CFG) stored in the warehouse that is distributed to sites over the course of a study. Materials, and successor materials, if necessary, are assigned to each kit type.
kit type switch demand: An event type used to define the additional demand required to front-load sites with a new kit type when the validity of the current kit type is due to end. Kit type validity periods are defined with respect to treatments on scenario level.
label group: Group for indicating that several countries/regions have the same regulatory and country/region requirements and can therefore share the same materials.
lead molecule: The chief pharmaceutical substance being investigated in the study. Study lead molecules are configured either manually using the Manage Study Configurations app or via an API.
lean study: A study that requires no scenarios, demand forecasts, or treatment schedules. Demand for kit types is calculated externally and imported via spreadsheet.
LSFV: Last subject first visit.
LSLV: Last subject last visit.
medication kit: A data object that represents a single physical item of CFG material and that is uniquely identified by a medication number, a study, and a protocol ID. The main purpose of this object is to serialize treatment kits and enable full tracking and tracing. A medication kit can be assigned to various categories of reference document, including process orders, sales orders, and inbound and outbound deliveries.
medication list: A collection of unique medication numbers for a specific clinical study used to serialize treatment kits and enable full tracking and tracing. The medication numbers in a medication list have unique sequence numbers and are allocated to defined study kit types. The correct quantity of medication numbers is assigned to a process order when it's released. Medication numbers are printed on kit labels in the defined sequence during the packaging process.
Packed at Risk: Status indicating that a planned or filed shelf life is used to calculate the expiry date instead of the approved shelf life. Goods can be packed at risk so that packaging can start without delay when the planned or filed shelf life hasn't yet been approved by the relevant regulatory authority, but is expected to be approved before the kits are used.
PCN: PCN stands for packaging control number. It is a virtual batch used to group together process orders that will be packaged together to maintain blinding in the case of blinded orders, or that share the same expiry date. The expiry date is printed on the labels of all the CFGs included in the PCN.
planned shelf life: A future product shelf life that has not yet been submitted to regulatory authorities, but is known to the trial manager and can be used to pack at risk.
period: Component of a treatment schedule whose duration indicates the time span between two visit and/or dispensing events. A non-dispensing period could represent, for example, the screening of subjects, while the start of a dispensing period usually marks the dispensing of medication, such as a drug product, comparator, or placebo.
pool ID: CFGs that are assignable to multiple studies are assigned a pool ID. If available, the pool ID is used to identify the applicable shelf life version instead of a study ID.
randomization group: Grouping used to logically link treatment groups in order to apply a subject ratio across them, or to separate treatment groups that have no relationship according to the study protocol in order to avoid mixing up subject ratios. Randomization groups can represent the phases of a multiphase study (for example, the dose escalation phase or the expansion phase).

replacement demand: An event type used to supply sites with additional quantities of kit types at a specific time, as a buffer. Typically created to replace kits that will soon expire.
scenario: Simulation for planning demand for investigational products. Each study can have multiple scenarios, but only one scenario can be active at any given time. Scenarios of a study typically differ in terms of the expected enrollment curve or rate, and can be compared in the Manage Demand Forecasts app.
shelf life version: A collection of regulatory information that applies to a primary pack material used in a study or, if flavors are used, to a specific combination of study and flavor ID. The information includes the total (technical) shelf life and country-specific shelf lives - approved, filed, or planned.
shipping lead time: Lead time in days between dispatch of the clinical finished goods (CGFs) from the distributing depot and their availability at the clinical sites. It includes all process steps related to the shipping and sending of the CFGs (for example, preparation work, dispatching, and goods receipt control). The shipping lead time is an approximate value representing all sites within the site group, based on experience.
site buffer: One element of the do not ship (DNS) lead time, which is checked as part of the site shipment request (sales order) validation. The site buffer, given in days, helps to determine the required expiration date to associate with the demand elements (PIRs).
site group: Set of sites involved in a study that are supplied from the same distributing depot. In most cases, a country forms one site group, but larger countries are usually split up into several site groups, each with its own distributing depot (for example, US West and US East).
site seeding demand: Initial allocation of kit types to make a sufficient quantity available at a site before FSFV. Site seeding is an event type.
sponsor: A person or entity who takes responsibility for and initiates a clinical investigation.
study phase: Phase of a study, such as Phase II or Phase III.
study type: Type of study, such as single or double blinded.
switch rate: Percentage of subjects who move from one treatment group to another at the end of a period. Subjects can only be switched within a randomization group as of the next period in the treatment schedule.
therapeutic area: Area of therapy that a study is in, such as oncology or cardiology.
total shelf life: The maximum length of time that a product (medication) can be stored for use, sale, and consumption. Synonyms: analytical shelf life, internal shelf life.
treatment: Specific therapy given to a subject, such as a drug product, comparator, auxiliary product, and/or placebo. A treatment consists of a single kit type or a combination of various kit types. One or more treatments can be assigned to a dispensing period.
treatment group: Group of subjects receiving the same treatment or succession of treatments over the course of a study. A treatment group consists of a specific number of subjects determined via a randomization ratio or defined manually. Multiple treatment groups form a randomization group.
treatment schedule: Relative timetable that defines visit and dispensing events for subjects participating in a study. A treatment schedule consists of periods and is created for each treatment group. By default, all treatment schedules belonging to the same randomization group are synchronized, but they can have different relative starting points.