Check Action Types
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A Check Action is the activity that an Edit Check will perform if a Check Step is found to be true.

If a particular action is associated with a specific data point, the appropriate folder/form/fields must be specified to determine where the action should occur.

The following Check Action Types are available:

Check Action Type

Description

Add Comment

Adds a comment into the audit trail of the specified data point; requires message text.

Add Deviation

Opens a protocol deviation at the specified data point; requires deviation class and code.

Add Form

Adds form at the level of the specified data point; requires a form.

Add Matrix

Adds a matrix to the subject's task list; requires a matrix.

Custom Function

Adds client specific check function; requires a custom function.

Merge Matrix Old

Merge Matrix Old is a legacy option that is maintained for upgrades and custom functions built on prior versions of Rave. This check action should not be used when building new edit checks.

Merge Matrix

Adds a form to folder that already exists; requires a folder.

Open Query

Opens a query at the specified data point; requires a query message and a marking group.  Optional settings include Require Response (adds free text box to the query) and Require Manual Close (does not automatically close the query when data point is changed and re-submitted)

Place Sticky

Places a sticky note at the specified data point; requires text and a marking group.

Requires Review

Marks the specified data point as requiring review; requires a review group.

Requires Verification

Marks the specified data point as requiring verification.

Send Message

Sends a message to a user or a group of users.  This may be specified by user group, role or individual user; requires text and target.  An optional urgency level (normal, low, or high) may be set.

Note: For email messages with confirmation, when the Check box "Confirmation" is checked, Rave will create a simple edit check that will send an email requiring confirmation.  Default is unchecked.  Email message can be flagged as "Normal", "Low", or "High".

Set DataPoint

Sets the specified data point to a particular value; requires a value.

Set Subject Name

Sets the value of the specified data point as the subject name.

Set Subject Status

Sets the subject status to From Data Value, enrolled, rejected, or terminated.

Set Time Forward

Updates the subject calendar using the date in the specified data point.

Set Time Zero

Sets the initial date from which the target dates in the subject calendar and al other dates specified in the folders are calculated.

Set Nonconformant

Marks the specified data point non-conformant.

Update Folder Name

Updates the folder name by suffixing the specified data point.

Update Form Name

Updates the form name by suffixing the specified data point.

Set Secondary Subject Name

Sets the value of the specified data point as the secondary subject name.

Set DataPoint Visible

Sets visible property of the specified data point on or off.

Set Form Requires Signature

Sets a Form as requiring signature.

Set Folder Requires Signature

Sets a Folder as requiring signature.

Set Subject Requires Signature

Sets a subject as requiring signature.

Set Dynamic Search List

Specifies the corresponding custom function and the field displaying it.

Balance Randomize

Balance randomizes the subject. Randomization is the transaction between Rave and Balance where Rave provides Balance information about the subject, allowing Balance to perform a randomization. Upon randomization, Balance returns Rave an acknowledgment (by way of a comment) that the subject was randomized.

Balance Randomize and Dispense

Balance randomizes the subject and dispenses items to subject. Subjects can be randomized and supply dispensed in the same transaction. Additionally, a site inventory check can be run as part of the same transaction. This functionality is available for both Dynamic and Permuted Block design.

Balance Dispense

When a study uses the drug dispense and inventory management feature of Balance, a form must be designed to capture dispensation of kits. The Balance Dispense edit check action supports the ability to dispense treatment kits to the subject. After the edit check is executed, Balance returns to Rave, the treatment kits that should be dispensed to that subject.

Balance Redispense

When a study uses the drug re-dispense and inventory management feature of Balance, a form must be designed to capture re-dispensation of kits. The Balance Redispense edit check action supports the ability to re-dispense treatment kits to the subject. After the edit check is executed, Balance returns to Rave, the treatment kits that should be redispensed to that subject.

Balance Create Subject

Balance Create Subject check action supports the registration of a Rave subject in Balance, if the subject needs to be added to Balance prior to randomization. The check step and check action should be placed on the data point where the success comment or error query related to subject registration should occur. If randomization factors are collected in Rave, the data points that collect the randomization factors should be included as check steps. This ensures that the subject is registered in Balance with the randomization factors.

Balance Subject Deactivate

Subjects can be deactivated and reactivated in Balance from Rave EDC. Balance Subject Deactivate check action will not allow dispensation to that subject and will exclude the subject from the predictive shipping calculations that determine when to give shipments of inventory items to the site.

Balance Subject Exclude

Balance Subject Exclude check action supports the ability to exclude subjects from a study that uses dynamic allocation randomization in Balance.

Mark Activity Complete

Related to Activity based payments in Medidata CTMS, the Mark Activity Complete Check Action allows Rave study builders to create an edit check that marks a group of fields as complete. Fields included in the Check Action are marked complete once all fields meet certain defined requirements.

Note: Activities are marked as complete in the Rave database only, and are not visible in Rave.

 

Note: Prior to Rave 2013.4.0, in order to configure randomization and dispensation by way of Balance, it was necessary to utilize a set of custom functions. Case Report Forms (CRF) that are currently in use are not required to be modified, as the custom functions will not be removed from a URL. New studies using Balance should use the new edit check actions mentioned in the table in place of the custom functions.

 

Note: Beginning Rave 2014.1.0, when specifying draft settings for a project or a global library in Rave Architect or Architect Loader, the primary form assigned to the subject cannot have an edit check with a check action of type Add Matrix, Merge Matrix, or Merge Matrix Old if all steps in the edit check are for the primary form. If you attempt to publish the draft without correcting the edit check, it will result in an error.

 

Copyright © 2014 Medidata Solutions, Inc. All rights reserved.



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