Summary

This article covers the RM 2.1.0 Release notes. 

Updates in the RM 2.1.0 Release

This section describes what’s changed in the most recent patch releases of RM after 2.1.0. We list the most recent patch first:

RM 2.1.2

  • 19271: Improvements for lock on drug inventory needed
  • 19280: 2.1.2 Release Notes

RM 2.1.1

  • 19064: Activation patient to a treatment gives ClickOS error
  • 19065: Add randomization schedule import
  • 19102: 2.1.1 Release Notes

RM 2.1.0

Welcome to Randomization Manager version 2.1.0. The release information presented below is organized into the following categories:

Randomization

17799: Check Activation Criteria

Must check activation criteria for inclusion before activating/randomizing a patient.

17800: Activate/Randomize Patient to a Treatment

Patients should be activated/randomized to a treatment type.

17801: Allow Stratification Based on Expression

Activation should allow stratification based on expression.

17802: Assign Treatment Based on Specified Algorithm

Activation should assign treatment based on specified algorithm.

17803: Assign Treatment Based on Standard Block Algorithm

Activation support for Standard Block algorithm.

17804: Assign Treatment Based on Minimization Algorithm

Activation support for Minimization algorithm.

17805: Assign Treatment Based on Institution Balancing Algorithm

Activation support for Institution Balancing algorithm.

17806: Assign Treatment Based on Custom Algorithm

Activation support for a custom algorithm.

17808: Activation ID Generation

Activation should support the generation of an ID.

17810: Sequential Activation Id

Activation should support the generation of a sequential (or incremental) ID.

17811: Custom Activation Id

Activation should support the generation of a custom ID.

17812: Activation Assignments

Activation should support assignments.

17813: Activation Id

Activation should support the assignment of an Activation Id.

17814: Activation Date

Activation should support the assignment of an Activation Date.

17815: Activation Time

Activation should support the assignment of an Activation Time.

17817: Activation Date and Time

Activation should support the assignment of an Activation Date and Time.

17818: Treatment Type

Activation should support the assignment of a Treatment Type.

17819: Activated By

Activation should support the assignment of Activated By – user’s name.

17820: View Receipts

Activation should support the ability to view Receipts.

17821: Configurable List of Receipts

Activation should support the ability to configure receipts.

17822: Display Receipt

Activation should support the ability to display receipts.

17823: Receipt Displayed at Time of Activation

Activation/Randomization receipt should be displayed at time of the activation.

17824: Receipt Displayed at Any Time after Activation

Receipt should be available for redisplay at any time after activation.

17825: Receipt Displayed Based on viewBlind Permission

Receipts should be displayed based on viewBlind permission.

17826: Trigger Activation Email

Activation/Randomization should support triggering an email at time of activation.

17834: Import Setting from configuration

Ability to import settings from the configuration (Randomization XML).

17836: Import Strata and Factors

Ability to import strata and factors from configuration.

17838: Ability to Populate Strata

Setup of the Randomization Manager should include the ability to populate strata.

17962: Configurable Options: Email Address

The To: address field should contain configurable options.

17963: Configurable Options: Email Template

The email template should be configurable: default or custom.

17964: Custom Email Template

The custom email template should support context key and value.

17990: Randomization Summary R

Generate radnomization summary report.

18420: Add the access to the Audit Manager and turn on the text export

Add access to the Audit Manager for DT SD and DT Debug role and a Text Export with audits turned on.

Trial Supply Management

17752: Add warning message if Expiration Date is in different format

Added warning message if Expiration Date is in different format.

17753: Add error check on Import Inventory page

Added ‘Error: Confused on expiration date! Column index and default value cannot be both provided.’ message

17809: Generate Drug Label

Activation should support the generation of the Drug Label.

17835: Import Drug and Treatment Type

JSP and Java files should not be listed with the exception of the Java Developer Role

17837: Import Packaging Companies

Ability to import packaging companies from configuration.

17839: Ability to Import Inventory

The setup of the Randomization Manager should include the ability to Import Inventory.

17840: Ability to Populate Inventory

The setup of the Randomization Manager should include the ability to populate inventory.

17842: Assign Drug to Patient Based on Treatment

Drug Inventory should assign drug to patient based on treatment.

17843: Decrement Inventory

Upon assigning drug to patient, inventory should be decremented.

17844: Trigger Re-Supply if Threshold is Met

If assignment of drug to patient decrements inventory to the defined threshold level, a re-supply email should be triggered.

17845: Trigger Inventory Empty Event

If assignment of drug to patient decrements inventory to a point that is insufficient for any drug type, an inventory empty email should be triggered.

17846: Initial Shipments

Drug Inventory should support Initial Shipments.

17847: Send User-defined Amount of Drug

Initial shipments should send user-defined amount of selected drug type to site(s).

17848: Trigger Initial Shipment Email

Initial Shipments should trigger an initial shipment email.

17849: Re-supply Shipments

Drug Inventory should support re-supply shipments.

17850: Reaching Configurable Threshold Triggers Re-Supply

Re-supply shipments should be triggered when a drug reaches a configurable threshold.

17851: Evaluation of Drugs in Same Re-supply Group

Drugs included in the same re-supply group are evaluated for inclusion in the shipment.

17852: Re-supply Drug Calculation

Amount for each drug will be calculated using the formula: resupply level – amount at site – amount in mail

17853: Trigger Re-supply Email

Email should be sent when re-supply shipment is triggered.

17854: Shipment Listing

Drug Inventory should support a shipment listing.

17855: Display Shipment Listing

Shipment Listing should be displayed within the application.

17856: Shipment Listing Displayed on Study Homepage

Based on permissions, the shipment listing should be displayed on the study home page with the following items:

  • 1. Date
  • 2. Inventory Id
  • 3. Status
  • 4. Confirm link
  • 5. Cancel link

17857: Shipment Listing is Inclusive of Data Pryamid

The shipment listing displayed on the study homepage is inclusive of the data pyramid.

17858: Shipment Confirmation

The Shipment Listing should allow for the confirmation of drug.

17859: Confirm Status of Individual Container

Shipment Confirmation should provide the ability to confirm status of an individual container as Received or Missing/Broken.

17860: Confirm Date Received

Shipment Confirmation should provide the ability to confirm the date received.

17861: Confirmation Comment

Shipment Confirmation should provide the ability to denote a comment about the shipment.

17862: Shipment Confirmation Actions

Shipment confirmation should support defined actions.

17863: Confirmed Action

Shipment Confirmation should remove the item from the list upon confirmation.

17864: Partially Confirmed Action

Shipment Confirmation should update Status as Partial if a portion of the shipment is Missing or Broken.

17865: Store Inputted Data

Shipment Confirmation should store inputted data from the confirmation process.

17866: Add Shipment to Site Inventory

Confirmation of shipment should add shipment to site drug inventory.

17867: Shipment Confirmation Email

Confirmation of shipment should trigger email.

17868: Shipment Cancellation

The Shipment Listing should support the ability to cancel a shipment.

17869: Date Canceled

Shipment cancellation should included the Date Canceled.

17870: Cancellation Comment

Shipment cancellation should provide the ability to capture a Comment by the user.

17871: Shipment Cancellation Actions

Shipment cancellation should support defined actions.

17872: Cancellation Action

Shipment cancellation should remove the item from the list.

17873: Trigger Inventory Empty Event

Shipment cancellation should store data inputted.

17874: Return Shipment to Inventory

The cancellation of a shipment should return the shipment back to the packaging company’s inventory.

17941: Send User-defined Amount of Drug

In Inventory Summary report location column should display question text. The Status column should display ‘Received and usable’.

17965: Reporting: Inventory Listing

Randomization should provide an inventory listing for reporting purposes.

17966: Drug Assignment after Activation

Drug should be assigned after successful activation.

18224: Add extra questions to the ‘drugAssignmentReceipt’ form

Add the following questions to the ‘drugAssignmentReceipt’ form:

  • 1. assignmentId
  • 2. assignedDrugAmount
  • 3. assignmentQuestionId

Documentation

  • 19032: 2.1.0 Release Notes

  • 19032: 2.1.0 Release Notes

    Release notes for the Randomization Manager 2.1.0 Release.

    Outstanding Issues

    • 18983: RuntimeException when change Assignment Type to sequential
    • 19033: Randomization Manager Manual





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