| Dashboard |
The dashboard generally displays upon initial log in to the system (permission based) and provides details and/or functionality about your study/site/depot/system. |
| Depot |
A physical location at which inventory and investigational products are located. A depot may be associated with one (1) or multiple Sites. |
| Depot Users |
System users who are responsible for handling shipments and study kits at depots. |
| eApproval |
Your system may be configured to require eApproval when adding or updating configuration or data in the system. Enter or select a reason for the action and enter your credentials to electronically approve an action. |
| Facility |
In this system, a facility is a Shipping site.
Refer to for Facility=Shipping Site additional information. |
| Site |
Study sites are defined locations at which subject visits may occur. Sites may be associated with facilities and depots to manage product. |
| Site Users |
Investigators and other personnel who administer subjects at a study site. |
| Study Administrators |
System users who set up and administer a study in this system. |
| Study Managers |
System users who are responsible for the overall study and may need to manage Cohorts, Subject Capping, and/or Site Activations. |
| Study Site |
A Study Site is the location where Subjects are screened, enrolled, and followed throughout the course of a study. In the Mentor RTSM, every Study Site has a Facility configured to it for the purposes of shipping drug to the Site. Refer to Study Site vs Shipping Site/Facility for additional information. |
| Supply Managers |
System users who are responsible for Supplies, Shipments, and/or Resupply Management. |
| System Administrator |
A restricted group of system users who can manage System-level functionality across all studies. |
| Inventory / Investigational Product Dispensing – refer to the terms below for information about dispensing type options.
Remember: The Dispensing Types are configured in Blinded Mode (e.g., Kit Descriptions are hidden from users unless they have unblinded permissions) OR Open-blind Mode (e.g., all users view the Kit Description). The dispense type display is based on the study protocol and user permissions, except for unnumbered Kits (i.e., Bulk Supply) which are always open-blind. |
| Direct to Patient (Dispensing) |
This term refers to Assignment of Drug (or other products) that is sent directly to a patient location (without requiring a visit to Study Site). Shipments to the subject may originate from either a Central Pharmacy or directly from the Study Site.
- At time of dispensing, the user is prompted to select the shipment origination point (e.g., Central Pharmacy, Study Site).
- If no product is being sent to the Study Site, select the Central Pharmacy option. If the User selects “Study Site,” an error message displays onscreen. User must repeat the process and select the Central Pharmacy option.
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| Dispense Numbered Kits (Discrete Kits) |
- When the subject visit is configured to dispense numbered kits (i.e. discrete kits); then the system assigns the configured quantity of uniquely numbered kits to the selected subject.
- Discrete kits may be handled in a blinded mode or open-blind mode in this system, based on the study protocol.
- After you confirm the dispense drug action, the system displays the uniquely numbered kits to assign to the subject.
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| Dispense Unnumbered Kits (Bulk Supply) |
- When the subject visit is configured to dispense unnumbered kits (i.e., bulk supply), then instead of assigning a uniquely numbered kit to the selected subject, the system assigns a quantity of dispensing units from a specific Supply Lot.
- This bulk quantity may be number of pills, number of bottles, or any other defined unit-type for the study protocol. Bulk supply is handled in an “open-blind mode” in this system.
- After you confirm the dispense drug action, the system displays the quantity of dispensing units to assign, and the specific Lot Identifier, Kit Description, and Kit Type.
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| Dispensing Set Options |
- Your system may be configured to dispense multiple kits to a subject or allow you to select a kit multiplier, based on custom data collected at a visit.
- The dispensing set quantity multiplier is applied during a dispensing step associated with a multiplier.
- This feature allows you to select the number of kits to dispense.
- Upon selection, the confirmation screen displays the number of kits dispensed.
- For fixed dosing, there is a fixed multiplier (if configured).
- For multiple dispensing sets, the configured multiple sets display in the EUS during the dispensing step.
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| Information Only Dispensing |
- Some studies dispense drug that has either a concomitant medication or needs to be obtained at a pharmacy (locally sourced drug supplies).
- This system manages these dispensations by configuring Info-Only study kit types that display at the subject dispensing transaction along with any other required kit IDs that the system tracks.
- Once you confirm that you want to perform a dispensing action from the selected Subject Identifier, the system displays the kit assignments based on the study protocol.
- The info-only section is not an assignment of either a numbered or an unnumbered kit tracked through this system. It provides a description of the locally sourced drug to dispense along with instructions or notes and a quantity, based on the study protocol.
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| Pre-Allocation Dispensing |
- When a dispensing set contains both Discrete and Bulk Kits and is set to be dispensed as part of a Pre-allocation request, even the Bulk Kits would not be predicted when Predictive Resupply runs for Current Subjects and / or Future Subjects if you are predicting future drug demand.
- The “Ship on demand” (pre-allocation request) feature is added functionality which allows set up of pre-allocation requests so that the system knows to “Ship on Demand.”
- Once you confirm that you want to perform a dispensing from the selected Subject Identifier, the system displays the kit assignments based on the study protocol.
- Remember: Bulk inventory cannot be pre-allocated.
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| Titration |
- When the subject visit is configured to be a “Titration Dosing,” the system presents you with options, including:
- Titrated Down x Levels
- Stay the Same Level
- Titrated Up x Levels
- Note: “x” is the number of levels the subject is allowed to move up or down at that visit.
- The pre-configured dosing levels of “Down x,” “Stay the Same,” and “Up x” are based on the study protocol.
- The Titration dosing is executed in a blinded mode where you may not know the actual dose level (e.g., 10 mg vs. 20 mg) just that the subject needs to go up or down a level.
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| User Choice Dispensing |
- When the subject visit is configured to be a “User Choice” dispensing, then the system presents dispensing options to choose for the selected subject.
- User choice operates in either open blind mode or in blinded mode by providing a set of “masked” choices, which do not reveal the underlying drug being dispensed (E.g., Low, Medium, and High dose).
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