Summary

This article covers Partial Metadata Status

Table of Contents

Design | System 

With the Partial Metadata Status feature you can set which questions are required for the Data Review, Signature and SDV metadata statuses through the configuration of metadata status plans. For the SDV metadata status, you can also configure dynamic selection that randomly selects forms required for SDVing based on the percent chance that the form should be SDVed.

Plans

In order to use the Partial Metadata status feature, several worksheets must be configured. The first worksheet is the Plans worksheet.

Complete Basic Plan Configurations

  1. Plan ID: Enter a unique number for the ID. These are usually assigned sequentially starting with the number 1.
  2. Type:
    • Enter ‘Signature’ if the plan will be for the Signature status
    • Enter ‘Data Review’ if the plan will be for the Data Review status
    • Enter ‘SDV’ if the plan will be for the SDV status
  3. Name: Enter a short name for the plan.
    • Example: Signature 1
  4. Description: Enter a short description for the plan.
    • Example: Signature Plan for Site 1
  5. Expression: Enter an expression that uniquely defines when the plan should be enforced.
    • Example: [toolID] == 23512
Note: The plans are evaluated in the order that they appear on the worksheet. When multiple plans exist for a specific status type, the first plan whose expression returns true is associated with the subject for a particular plan type. The plan is assigned to the subject when the subject is created.



Complete Dynamic Plan Configurations

For each SDV type plan, two additional parameters may be included directly after the SDV plan is declared. These two parameters allow you to change the percentage of forms required based on how the study, site or subject is evaluated. Common uses for this feature include increasing the amount of required SDVing on certain visits or decreasing the amount of required SDVing for a user with a good user quality score.

When operating under a dynamic plan, forms are designated as “Not Applicable” or “Required” for SDV based on the plan and the configuration of the Question Layout Template. The designation of “Not Applicable” occurs when the forms are created (for example, when the subject is enrolled, when a dynamic form is created or when a script inserts the form into the casebook). The designation of “Required” occurs at the point of initial entry of data on the form.

  1. Dynamic Percentage: Enter a whole number between 1 and 100 to designate the percent chance that the form should be SDVed.
    • Example: If the Dynamic Percentage is 50, each form has a 50% chance of being selected as requiring SDV. This is independent of any other forms in the system.



Note: When defining Dynamic Percentages for Plans, the Percentage value must be unique per row. If you have two formTypes that require 80 percent the expression should include both form types “type == ‘pe’ OR type == ‘vs’”.


  1. Dynamic Expression: Enter an expression that uniquely defines when the percentage should be enforced.
    • Example: While the answer to a specific question could be used as part of an expression, standard properties, constants and offsets can also be used as shown with the following example:  studyStartDate + 3|M < @@currentDate



Note: If no expression matches (i.e. all expressions return false), the chance becomes 0%.



Question Layout-Template

After each Plan has been configured on the Plans worksheet, the questions must be configured for each plan on the Question Layout – Template worksheet.

  1. For each plan, add a new column header called ‘Plan_’ followed by the Plan ID for that plan.
    • Example: Plan_1
  2. For each question, specify how it will be incorporated into the plan as described in the next section.



Note: If the plan is not filled in for a particular question, the question is set to be required.


Question Incorporation

Depending on the metatdata status type, two to three options are available when specifying how the question should be incorporated into the plan.

Required

The question is included in the plan and must be marked as either data reviewed, signed or SDVed depending on the plan

No

The question is not included in the plan and does not need to be marked as either data reviewed, signed, or SDVed depending on the plan.

Optional

Only used with SDV plans. Depending on the Dynamic Percentage set on the Plans worksheet, the question may be required or not required for SDV.
Optional questions are the only questions considered in the dynamic percentages for inclusion or exclusion.



Note: Plan values are always established based on questions, and the default assumption is always ‘Required’. This means that if a dynamic form summary, like that for Adverse Events, has no questions, it will default to ‘Required’. Changing this behavior is possible by adding a question like “Were there any Adverse Events?” to the summary and making it not required in the plan. This would render SDV, Data Review, etc. unnecessary on the summary form.


Roles

Three actions can also be configured to address mid-study changes and overriding plans.

Add Reconcile Action

The reconcile action can be useful when changes are made to the Data Architect file. For example, if questions are changed from “No” to “Required” or additional fields are added, this mid-study change utility can be used to update the records.

  1. Actions: Enter ‘metadata – reconcile plans’
  2. Actions Required: Enter ‘reconcileMetaDataPlans’
  3. Screens Required: Leave this column blank.
  4. Select the Roles that should be able to activate the feature by placing an ‘X’ in the appropriate columns.



Add Change Plan Action

The Change Plan action is used to move a subject from one plan to another. When configuring access to this action, keep the following in mind:

  • If you have forms that are dynamically selected and a plan change moves them to “required” or “N/A”, a subsequent change back to “optional” will re-evaluate all of the forms where data entry has already occurred. This could lead to a significant number of forms needing SDV.
  • If a subject has SDVed forms and the plan for the subject is changed such that the forms are no longer required for SDV, these SDVed forms will no longer count towards the plan.
  1. Actions: Enter ‘metadata – change plans’
  2. Actions Required: Enter ‘changeMetaDataPlans’
  3. Screens Required: Leave this column blank.
  4. Select the Roles that should be able to activate the feature by placing an ‘X’ in the appropriate columns.



Add RequireSDV Action

Users with this permission can set a form to require SDVing regardless of the plan.

  1. Actions: Enter ‘metadata – Require SDV’
  2. Actions Required: Enter ‘requireSDV’
  3. Screens Required: Leave this column blank.
  4. Select the Roles that should be able to activate the feature by placing an ‘X’ in the appropriate columns.



Add Reconcile MetaData Counts Action

This reconcile action may be used to update the metadata counts for any forms that may have changed and is available in the Roles sheet of the DA template.

  1. Actions: Enter ‘Reconcile MetaData Counts’.
  2. Actions Required: Enter ‘reconcileMetaDataCounts’.
  3. Screens Required: Leave this column blank.
  4. Select the Roles that should be able to activate the feature by placing an ‘X’ in the appropriate columns.


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