Object

Edit Action

Definition

Item

Calendar Notification

Generates an email notification regarding an appointments (future patient visit date, etc.). The Calendar event is attached in the email in a format of ics file which allows patients to add appointments to their personal or site calendar. The location of the event is Site Caption.

The Calendar event file contains the UTC time, so that it picks up correct time zone from recipient’s machine. If datetime comes from the form, then it is converted to UTC from user’s time prior to saving it into the calendar file. If form with edit is saved by Patient Data Entry user, then Calendar Notification is sent to that user only, otherwise the notification is sent to all subscribers who have that permission chosen in TrialMaster. The email and calendar subject and body is translated to the language of the user it is sent to.

When adding an edit check and selecting Calendar Notification from the Edit Action drop-down of the Edit Check dialog, the following fields display below:

·       Notification Name - default: “Calendar event” which comes from Message field

·       Subject – subject of the email

·       Date - start date in the format yyyy/MM/dd

·       Time – start time in the format HH:mm

·       Duration – duration in minutes

·       Body – message of the email and calendar

·       Recipients  - Drop-down combo box with options that indicate where the calendar notification will be sent:

o      "Patient and Site subscribers" (default)

o      "Patient only” – (PDE user) PDE must be subscribed to calendar notifications. Send notification only to the patient associated with the iCRF

o      "Site subscribers only"  - Send notification to all users with access to the site that are not patient users

Change Notification

Generates notification to specified users when a condition is met (email or TM message). Users are specified by role or individual within TrialMaster (Administer > Roles > Notifications). The message can contain item values (will display stored value, unless modified via CSF). A flag item can be used to control whether a message is sent more than once (use DVC to set flag to ‘1’ after sending first message, place flag last on form). Click here for an example.

Data Value Advice (DVA)

Has Action and Data Expressions:

·        The Action Expression determines when the check executes (often set to True).

·        The Data Expression returns a value to the item.

The DVA executes in real time as data changes on the form, so the TrialMaster user will see values updating if the field is visible and is affected by the data they are entering.

A DVA should always return a value, either fixed based on a condition such as GroupInstanceNo or FormInstanceNo (or a combination of such), or the current visit, or a value calculated based on data entered by the user. If no value is calculated, an empty string (‘’) should be returned.

Only one DVA should be present for any given item, so that they do not conflict (exception in some cases if Action Expression takes Form or Group InstanceNo into account).

Example uses:

·       Populate ID values sequentially on a Form based on FormInstanceNo and GroupInstanceNo

·       Populate an expected date by adding or subtracting days from an entered date

·       Populate Test names such as Physical Exam, ECG, Vital Signs, etc., or Timepoints

·       Populate the value of IETEST when IETESTCD is entered

·       Copy a value from one form to another to simplify edit check writing

·       Populate Verbatim Term, Country, Formulation, etc., into coding fields

Note: If you use a DVC and the Trial Configuration Setting to allow saving to no-data forms without setting to Incomplete, you can push the value to the form prior to form save – this populates the Visit Projection Report.

This DVA populates the Adverse Event ID number with the FormInstanceNo.

This DVA populates the Week 1 Expected Visit Date by adding 7 days to the Screening Visit date (when the Screening Visit date is not Empty). If you use a DVA, this value will populate when the form is saved.   

This DVA populates timepoints into a Repeat Tabular Group based on the GroupInstanceNo.

Data Value Change (DVC)

Calculates the value of a field when a Form is saved after defined criteria are met. The user does not see values updating if the field is visible and is affected by the data they are entering.  

A DVC is used:

·       To populate Expected Visit Dates without changing the form status, in order to enable the Visit Projection Report to work.

·       Any time you collect a value from a Unique Numbering Table (prevents possibility of reserved-but-unused table values, or conflict between users).

Disabled Hidden

Hides an item from a Form or group and removes any data entered.

Dynamic Code List Filter

Dynamically populates a CodeList which is filtered, based on the data from another item or some other criteria such as GroupInstanceNumber or Visit.

May assign to any item of control type ComboBoxDynamic at any scope level (group, form, visit, patient, site, or trial).

The action expression for the edit check must return either true or false.  The data expression for the edit check only executes if the action expression returns true.

The data expression of the edit on the item must return a string, which the system uses to match against the filters defined in the Filter column of the CodeList selected for this item. The data expression may include percent signs (%) to operate as a LIKE function. For example, “%ABC%” will return all CodeList entries where the filter contains ABC.

If the action expression returns false, then all the CodeList items for the selected Code List are returned and populated in the combobox in TrialMaster.

This edit check executes after any Dynamic CodeList Setup edits.

Executes on read-only objects.

Dynamic Code List Setup

Dynamically populates a set of existing data on one or more iCRFs.

Example: A concomitant medication form must collect medication taken for an adverse event. The item for recording the relevant AE is a combobox listing all the AEs for that patient.

May assign to any item of control type ComboBoxDynamic, and at any scope  level (group, form, visit, patient, site, or trial).

The Action Expression for the edit check must return either true or false.  The data expression for the edit check only executes if the action expression returns true. 

The Data Expression must return a JavaScript array with values that display in the combobox. 

Note:  You may use JavaScript programming to merge sets of data or to add hardcoded values, such as an entry of “N/A” in the adverse events list.

Example: The expression to list AEs for a concomitant medication is [Adverse Events][AE.*][AE01.1][AETERM].ALL. This function returns the adverse event term for all occurrences of the AE form in the Adverse Events visit.

If the action expression returns false, the list of items are not retrieved and the combobox is disabled in TrialMaster (greyed out).

Executes after Enabled edits and on read-only objects.

Enabled

The field is enabled for data entry based upon a defined condition.

Hidden

Hides an item from a form or group.

Note: When items, groups, or forms are hidden/unhidden via an edit check, a system-generated general note will be included in the audit trail indicating the OID (Object Identifier) of the edit check that hid/unhid the object.

Post-save Warning

The value of a field is validated against a defined condition. If the condition is met, a warning message displays as a reminder after saving the iCRF in TrialMaster.

Note:  Post-save warning does not work on hidden items.

Pre-save Warning

The value of a field is validated against a defined condition. If the condition is met, a warning message displays as a pop-up message on the field as a reminder before saving the iCRF in TrialMaster.

Read Only

The item is visible but no data may be entered by the user.

Required

The field is required to be completed based upon a defined condition.

Required Enabled

The field is enabled for data entry and required to be completed based upon a defined condition.

Valid

The value of a field is validated against a defined condition. If the condition is not met, the field becomes invalid and a bypass note must be submitted in TrialMaster to successfully save the iCRF in a "Completed" status.

Unique Value Required

Validates that a data value is unique within the scope of a trial, site, patient, visit or form. If it is not, a warning displays and the form cannot be saved in any status until the value is removed and a unique value is entered.

Example

Group

Caption Change

The text for the caption on the group is changed. A Caption Change edit changes the display value associated with that object when it displays in TrialMaster. The functionality is comparable across all objects that have this edit type available.

This edit check is adding the Visit Date to the caption of an Unscheduled Visit.

Enabled

The group fields are enabled for data entry based upon a defined condition.

Hidden

Hides a group from a form.

Read Only

The group is visible, but no data may be entered by the user.

Disabled Hidden

Hides a group from a Form and removes any data entered in the group’s items.

Form

Caption Change

The text for the caption on the form is changed.

Change to Incomplete

Reverts a form’s status to "Incomplete” status if the condition is met.

Enabled

The iCRF fields are enabled for data entry based upon a defined condition.

Hidden

Hides a form.

Disabled Hidden

Hides a form from a visit and removes any data entered.

Read Only

The form is visible but all fields are not enterable by the user.

Show in Add Form List

Show or hide the hyperlink for the iCRF on the Add Form page.

Show SAE on Save

Displays an SAE form after the form is saved, based upon a defined condition.

This edit action for an item triggers the SafetyLink process (usually the Serious flag on the AE form).

The SafetyLink process is launched on form save when the following applies:

·       Action expression must be set to “true;”.

·       Data expression must return “1”, if [AESER] item is set to “Yes”, otherwise “0”.

Note: Changes to other related fields are handled via the task list and notification system.

Visit

Caption Change

The text for the caption on the visit is changed.

Note: A Caption Change edit may be executed against a newly-created visit.

Create Form

Creates a specified form based upon a defined condition.

A Create Form edit creates an instance of the form within the specified visit.

The number of available form instances must be greater than the number of existing form instances for a new form to be created (e.g., 2 of 3 possible instances have been created).

Commonly used with Optional (0 of 1) forms that are triggered by a condition, such as a Pregnancy form being created when patient is Female and of child-bearing potential.

Notes:

·        This validation action is only available for Patient Visits.

·        A Create Form edit may be executed against a newly-created visit.

Example

Scheduled

Visits can be dynamically scheduled based upon an expression.  A Scheduled edit creates makes the visit that is visible to the user.

The visit property of “Scheduled” can be set to No when the Visit is created in TrialBuilder, and then changed to Yes via this edit check. This prevents users from accessing visits that should not yet be available.

Even if a Visit is created with Scheduled = No when the patient is created, the Visit exists on the back end of the database and is made visible via the edit check. For this reason, if you have many visits, it is recommended for patient creation efficiency  to set them to 0 of 1, and use a Create Visit check to show them to the user (the same applies for Hidden vs. Create Forms).

Example

Disabled Hidden

Hides a visit from a patient and disables the visit (removes any data entered).

Show in Add Form List

Controls whether a form can be added by the user using the Add Form function. Can be set to False when the patient is created, and then enabled based on some criteria. Commonly used for AE (Adverse Events) when AEYN = Y, CM when CMYN = Y, etc.

Example

Patient

Caption Change

The text for the caption on the patient is changed.

Create Visit

Creates a specified patient visit based upon a defined condition.

A Create Visit edit creates an instance of the visit within the patient.

The number of available visit instances must be greater than the number of existing visit instances for a new visit to be created (e.g., 2 of 3 possible instances have been created).

Commonly used with Optional (0 of 1) visits that are triggered by a condition, such as a follow-up visit being created when patient is discontinued.  

Also used with creating Cycle Visits in Oncology studies (see Dynamic Cycles slide deck for more information/details).

Example

Deactivate

Renders the patient inactive.

Example

Drop

Gives the patient a dropped status.

The values for Drop > Dropped, Enrolled > Enrolled can be programmed with the same code, or the Drop and Enrolled checks can use a DVA to pull the value from these fields.

Enrolled

Renders the patient as enrolled.

Deactivate /Drop/Enroll

Deactivate and Active have opposite conditions to be accounted for.

Example

The value returned by these edit checks controls the Patient Icon.

Show in Add Visit List

Controls whether the user can add a visit. Can be set to False when the patient is created, and then enabled based on some criteria. Commonly used for Unscheduled and other optional visits.

Example

Site/Trial

Caption Change

The text for the caption on the site/trial is changed.