Summary

This article covers the requirements and definition of configuration attributes.

Table of Contents

Requirements

The Configuration tab must have at least two entries: one for training and one for production. Both entries should outline the default configuration for the entire study. These two entries should also use different Bridge IDs to assure that training sites do not use resources designated for production sites. Additional entries can be used to configure sites individually.

Each property must be defined for Configurations assigned a level of 0. All other Configurations will automatically inherit property values defined for a lower level Configuration if the property is not set.

Definition of Configuration Attributes

Configuration ID

This attribute is a unique number to define each configuration for a group of sites. The configuration ID can’t be repeated and is referenced across multiple tabs within the dA (Strata, Activation, and Inventory). For example, configuration ID ‘1’ could be assigned to high enrolling sites and configuration ID ‘2’ for low enrolling sites. The expression field would also need to be used to specify which sites will use which configuration.

Level

This attribute specifies the hierarchy structure of the configuration. The higher level configuration will inherit the configuration from a lower level configuration. For example, level 0 is associated with the configuration for all sites, level 1 is associated with American sites, and level 2 is associated with European sites. If the configuration ID for American or European sites was never used in the study but was defined, the sites would inherit the configuration defined at level 0.

Expression

This attribute is used to evaluate tools. This means that tool based expressions can only be used. For example, [toolClassification]==’TRAINING’.

Description

This attribute is used to provide a description about the configuration. This attribute doesn’t display anywhere within the EDC and is specific to the dA.

Study

This attribute is used to provide the study or application name about the configuration. This attribute doesn’t display anywhere within the EDC and is specific to the dA.

Uses Randomization

This attribute is used to signify whether the configuration uses randomization or not. The two options available to this field are ‘no’ and ‘yes’. When the attribute is set to ‘yes’ the configuration will be able to use randomization and will be able to assign drug/device. If the attribute is set to ‘no’, the patient/subject will be able to randomize but no treatment will be assigned.

Define the Randomization Configuration For the Study

This initial configuration will be used in all cases unless additional configurations are defined as explained in the site-specific configuration section.

  1. Configuration ID: Enter the number, 1, for the Configuration ID at the study level.
  2. Level: Enter the number, 0.
  3. Expression: Enter ‘true’ since this will be an active configuration.
  4. Description: Enter a brief description to label your configuration.
  5. Study: Enter the Study or Application name.
  6. Uses Randomization: Enter “yes” if the study uses randomization and enter “no” otherwise. If set to no, it prevents drug assignments from occurring when a patient is activated.



There is a side effect when Uses Randomization is set to “no”. Because there is no assignment on activation, certain variables configured in the DA can resolve to the variable name. For example, if the variable ACTIVATION_drugTypeName normally resolves to something like “Placebo” or “DRUG-2015”, when Uses Randomization is set to no, it can resolve to “ACTIVATION_drugTypeName.” That in turn can cause deactivation to fail.


  1. Blinding: This field provides descriptive information about blinding in the study and has no impact on functionality. Enter “single”, “double”, or “none” depending on the blinding for your study.
  2. Algorithm:
    • Enter ‘com.clickfind.randomization.algorithm.Stratification’ if the study uses Stratified Blocks.
    • Enter ‘com.clickfind.randomization.algorithm.InstitutionalBalancing’ if the study uses Institution Balancing.
    • Enter ‘com.clickfind.randomization.algorithm.Minimization’ if the study uses Minimization.
  3. Institutional Balancing Threshold: If the study uses Institutional Balancing, enter the threshold value to be used by the algorithm to maintain a specific treatment type assignment balance within each site.
    • Example: If Site 1 has fives subjects that are assigned Treatment A and seven subjects that are assigned Treatment B, the difference between the assigned treatments is 2. If the threshold is set to 2, the next assignment will be to Treatment A to maintain a balance at the site and keep the difference from exceeding the threshold.
  4. Minimization Probability: If you selected ‘Minimization’ in step 8, enter a number between .01 and 1 to set the probability that the treatment that results in the smallest imbalance will occur.


Note: If no value is entered and Minimization is selected, the default value is 1.


  1. Minimization Imbalance Method: If you selected ‘Minimization’ in step 8, enter either ‘Range’ or ‘Variance’ as the method used to calculate the imbalance.



Note: If no value is entered and Minimization is selected, the default value is ‘Range.’


  1. Bridge ID: Enter an ID to specify which group of activation slots and drug containers should be used by the configuration.

Two bridge IDs must be used: one for training and one for production. If the production tools use Bridge ID 1 and the training tools use Bridge ID 2, changes made to the two types of tools will not affect each other.


Define the Randomization Configuration For the Sites

If inventory is managed at the site level, each site requires its own Configuration ID. If inventory is managed at the study level and site information does not need to be individually configured, you can skip this section.

Configuring site information individually can be useful to keep certain site configurations separate. For example, if a study has two sites in Europe and two in Asia, five Configuration IDs and three levels can be used as shown in the following configuration. With this configuration, the Europe sites can be configured to have one set of activation criteria and the Asia sites can have a different set of activation criteria, because the Europe sites and Asia sites have different levels.



  1. Configuration ID: Based on the Configuration IDs currently in use in the Configuration worksheet, enter the next available number in ascending order.
  2. Level: If only one level is needed for the sites, enter the number, 1. Otherwise, enter the appropriate level number.
  3. Expression: Enter ‘[toolID] == ‘ followed by the site’s ID.
    • This ID can be found in the Site form in the Trial Manager. Use the site’s tool ID.
  4. Fill out the remaining properties in the same manner as for the overall study.


Define the Randomization Configuration For the Training Tools

  1. Configuration ID: Based on the Configuration IDs currently in use in the Configuration worksheet, enter the next available number in ascending order.
  2. Level: If only one level is needed for the sites, enter the number, 1. Otherwise, enter the appropriate level number.
  3. Expression: To specify that this tool is used for training purposes only, enter: [toolClassification]==’TRAINING’


Note: This expression references the ‘Classification’ value set for each site in the Trial Manager.


  1. Bridge ID: Enter an ID that is different from the IDs used for production tools. This will prevent training sites from using resources designated for production sites.
  2. Fill out the remaining properties in the same manner as for the overall study.



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