Control Type(s)
Data Attribute
Definition
Attachment
Text
Text that will display next to the attachment icon
FileType
Defines allowable file types for the upload, surrounded by hash marks. E.g.,, #TXT#, #DAT#.
Note: For a list of file types not allowed, see section titled, File Extensions not Allowed in the TrialMaster 5.1 user manual.
CheckBox
Data Type
Note: For additional information see Define Data Types.
Defines the acceptable Data type for the field.
Data Types for CheckBoxes include:
· Float
· Int
· String
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
Checked Value
Defines the value of a CheckBox when checked.
Unchecked Value
Defines the value of a CheckBox when unchecked.
CheckBoxGroup
Note: For additional information see Define Data Types.
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
List of Sub Items
Defines each check box in the item.
Default (located under the Design attribute)
If you check this box, the sub item check box is checked by default.
ComboBox
CodeList
Defines which CodeList will be associated with the ComboBox.
Prefill Behavior
Prefill Behavior is no longer used.
Data Type
Note: For additional information see Define Data Types.
Defines the acceptable data type for the field.
Data Types for ComboBoxes include:
· Float
· Int
· String
Note: If a CodeList is selected for the Item, the appropriate Data Type will populate by default; however you may still change it.
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
Hour
HourMinute
HourMinuteSecond
Stop Word Group
Defined words that are allowed to appear in a field they would not normally appear in (i.e. a word in a numerical field).
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
HyperLink
Text
Defines the clickable text that will display as a hyperlink.
URL
For URL locations, defines the address where the hyperlink will lead.
Image
URL
Defines address where the Image is located.
Label
Text
Defines the Text that will appear in the Label.
ListBox
RadioButton
CodeList
Defines what CodeList will be associated with the ListBox or RadioButton.
Data Type
Note: For additional information see Define Data Types.
Defines the acceptable Data type for the field.
Data Types for ListBoxes and RadioButtons include:
· Float
· Int
· String
Note: If a CodeList is selected for the item, the appropriate Data Type will populate by default; however you may still change it.
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
TextArea
Data Type
Note: For additional information see Define Data Types.
Defines the acceptable Data type for the field.
Data Types for TextAreas and TextBoxes include:
· Boolean
· Date
· Float
· Int
· String
· Time
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
TextBox
Prefill Behavior
Prefill Behavior is no longer used.
Data Type
Note: For additional information see Define Data Types.
Defines the acceptable Data type for the field.
Data Types for TextAreas and TextBoxes include:
· Boolean
· Date
· Float
· Int
· String
· Time
Note: If a CodeList is selected for the item, the appropriate Data Type will populate by default; however you may still change it.
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
TextBox w/ MedDRA
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
MedDRA Term
Defines different terms used in association with MedDRA dictionary.
As a study designer, you can designate up to five reference items that appear alongside the verbatim term during coding. You can achieve this by selecting a Textbox with MedDRA Term, such as REFERENCE 1, REFERENCE 2 or REFERENCE 3 when defining an item in TrialBuilder and assigning the item with a mapping type of R in the dictionary mapping screen of the AutoEncoder utility. [Refer to the AutoEncoder Help for more information about the AutoEncoder (AEC) utility.]
To include a dictionary version, create a Textbox w/MedDRA item and assign VERSION as the MedDRA term.
To include the Match Method of a term, which indicates if the term was coded manually or autocoded, create a Textbox w/MedDRA item and assign MATCH_METHOD as the MedDRA term.
In this example, when the TrialMaster user enters the Verbatim Term "dizziness" in the iCRF, and the coding for the term is confirmed/reviewed /approved in AEC, the remaining fields are automatically populated with the AEC dictionary items. (The Verbatim Term was autocoded as a History Match as shown in the Match Method field on the bottom right of the form).
Important: If you implement a Mid-Study Change (MSC) that includes updates to coding fields or mapping, this will impact existing coded terms, as explained in the following examples:
· Adding a reference item: This will uncode existing terms. You must request a script from Anju to populate reference data for existing terms.
· Updating the Data Value Advice (DVA) edit check that populates the reference item and where the Trial level configuration setting “Auto Coding Revert on Reference Value Change” is set to Yes: this will update reference item values and uncode existing terms. You may request a script from Anju to restore coding data for existing terms.
· Adding or removing coding items or changing the mapping: this will uncode existing terms. You may request a script from Anju to modify the mapping and preserve the existing coding. Without this script, you must delete the existing module in AutoEncoder (AEC) and recreate it with the new mapping. As a result, you must request a script from Anju so that the existing terms will appear in the AEC table, and then all terms must be recoded.
TextBox w/ Search
CodeList
Defines what CodeList will be associated with the search.
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
TextBox w/ WhoDrug
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
WhoDrug Term
Defines different terms used in association with WhoDrug dictionary.
As a study designer, you can designate up to five reference items that appear alongside the verbatim term during coding. You can achieve this by selecting a Textbox with WhoDrug Term, such as REFERENCE 1, REFERENCE 2 or REFERENCE 3 when defining an item in TrialBuilder and assigning the item with a mapping type of R in the dictionary mapping screen of the AutoEncoder utility. [Refer to the AutoEncoder Help for more information about the AutoEncoder (AEC) utility].
To include a dictionary version, create a Textbox w/WhoDrug item and assign VERSION as the WhoDrug term.
To include the Match Method of a term which indicates if the term was coded manually or autocoded, create a Textbox w/ WhoDrug item and assign MATCH_METHOD as the WhoDrug term.
In this example, when the TrialMaster user enters the Verbatim Term "stridopa" in the iCRF, and the coding for the term is confirmed/reviewed /approved in AEC, the remaining fields are automatically populated with the AEC dictionary items. (The Verbatim Term was manually coded as a Dictionary Match as shown in the Match Method field on the bottom left of the form).
Important: If you implement a Mid-Study Change (MSC) that includes updates to coding fields or mapping, this will impact existing coded terms. See the TextBox w/ MedDRA control type for examples.
Timer
Stop Word Group
Allows the user to enter a duration that has elapsed.
Year
YearMonth
YearMonthDay
Stop Word Group
Defined words that are allowed to be entered in a field they would not normally be entered in (i.e. a word in a numerical field).
Required
Defines whether the Item is valid if left blank.
Required Text
Custom error message that displays if item is marked as required and left empty.
Default
Defines a default value for a field.
Future Date Allowed
Select No to have the system validate that a date in the future is not entered.
Note: The user’s timezone is taken into account when dates are entered.
Future Date Text
Customizable warning message that displays if Future Date is set to No, and the user enters a date in the future in TrialMaster.