Summary

This article contains configuration information for Trial Manager, Randomization, the Visit Schedule, and the Patient Management Report through the app properties worksheet. 

Table of Contents

The App Properties worksheet defines application-wide string properties, which may be used for display or report configuration. This file contains configuration information for Trial Manager, Randomization, the Visit Schedule, and the Patient Management Report. It is basically a container in which to store miscellaneous pieces of information using name/value pairs (references name/gets value).

Name

Name is the unique string defining the property.

Value

Value is the data to be stored for a particular property. The property groups are found in the table of contents at the top-right of this page.

Standard Properties

Note: All standard properties should be included for every study.

study

Study is the unique string defining the application within the system – the protocol identifier. The value of this property is displayed in the following places:

  • Header for Standard PDF forms
  • Header for PDF archivals
  • ODM exports

studyStartDate

This is the actual study start date as provided by client – the date when data will first be entered. This is the date used as the starting point for ranges used in the system. This is also the date used in the Trial Summary Trial Overview to determine the length of the trial, and it serves as the baseline.


Note: The studyStartDate property should be provided in the same format as the studyDateFormat (ie. If studyStartDate is '06/01/2011', the studyDateFormat should be 'MM/dd/yyyy'). If they are inconsistent, the designer will get an error when compiling the DataArchitect file. 


Note: The studyStartDate property is a date property only. Times (HH:mm) are not supported within this property. The only property where the time is applicable is in the studyAuditDateFormat.


studyDateFormat

The Java Date Format in which dates will be entered to allow proper parsing of the date or time of a Date type. (e.g., dd-MMM-yyyy, MM/dd/yyyy, etc.)

Note: The studyDateFormat property is a date property only. Times (HH:mm) are not supported within this property. The only property where the time is applicable is in the studyAuditDateFormat.

studyDuration

This defines the length of time of the study and must be a numeric field.

studyDurationUnit

This specifies the interval of time used to define the study’s duration. Use the singular form of the unit interval e.g., week, day, month, etc.

mostOftenAlertedCount

This defines how many Questions with Alerts will be displayed in the Trial Summary; e.g., 10 (standard).

mostOftenQueriedCount

This defines how many Questions Most Often Queried will be displayed in the Trial Summary; e.g., 10 (standard).

queriesOlderThanDays1

This allows for the specification of the larger number of days indicating the age of Open Queries in the Trial Summary; e.g., 14 (standard).

queriesOlderThanDays2

This allows for the specification of the smaller number of days indicating the age of Open Queries in the Trial Summary; e.g., 7 (standard).

visitOutlook

This allows for the forecast of expected subject (patient) visits during a specified amount of units of time, as displayed in the Trial Summary; e.g., 5 (standard). This variable is tied to the Visit Schedule. If a Visit Schedule is not defined, the Visit Summary parameters in Trial Summary will display 0 (zero).

Additional Properties

localizeImportLog = true

If set to true, this property will localize the import log in the user’s language. The detailed log file will use English

formTypeID-tabGroups,mode=’simple’

The formTypeID-tabGroups,mode=’simple’ where formTypeID contains the Form Type ID of the form with tab groups, property allows you to configure a new simplified tabular layout option for data entry that loads more rapidly and uses the space on the page more efficiently. The value accepts comma delimited and ranges (2-5) values.

If you create a table with a significant number of columns (10 or more), the screen width remains static in simple mode and may cause the columns to run off the page.

asciiOnly-Integer

If defined or set to ‘true’, this property will fire a black format alert if a field’s Data Type is Integer and non-ASCII characters are entered into the field. Please note this property is not disabled if set to ‘false’. If the property is to be disabled, it must not be defined in the properties.

asciiOnly-Date

If defined or set to ‘true’, this property will fire a black format alert if a field’s Data Type is Date and non-ASCII characters are entered into the field. Please note this property is not disabled if set to ‘false’. If the property is to be disabled, it must not be defined in the properties.

asciiOnly-PartialDate

If defined or set to ‘true’, this property will fire a black format alert if a field’s Data Type is Partial Date and non-ASCII characters are entered into the field. Please note this property is not disabled if set to ‘false’. If the property is to be disabled, it must not be defined in the properties.

asciiOnly-Float

If defined or set to ‘true’, this property will fire a black format alert if a field’s Data Type is Float and non-ASCII characters are entered into the field. Please note this property is not disabled if set to ‘false’. If the property is to be disabled, it must not be defined in the properties.

asciiOnly-String

If defined or set to ‘true’, this property will fire a black format alert if a field’s Data Type is String and non-ASCII characters are entered into the field. Please note this property is not disabled if set to ‘false’. If the property is to be disabled, it must not be defined in the properties.

enableCompleteStatus

The enableCompleteStatus property uses Boolean variables to define whether or not the In Progress step is removed from the Answer Status progress bar. If ‘false’, the In Progress step is included; if ‘true’ the In Progress step is removed.

hideAlertStatus

This uses Boolean variables to define whether the Alert Status column is displayed in the Global and Form Summaries. If ‘false,’ the Alert Status column will be displayed; if ‘true,’ the column will be hidden. If not set the default is ‘false’.

hideAnswerStatus

This uses Boolean variables to define whether the Answer Status column is displayed in the Global and Form Summaries. If ‘false,’ the Answer Status column will be displayed; if ‘true,’ the column will be hidden. If not set the default is ‘false’.

hideSdvStatus

This uses Boolean variables to define whether the Source Doc Verified column is displayed in the Global and Form Summaries. If ‘false,’ the SDV Status column will be displayed; if ‘true,’ the column will be hidden. If not set the default is ‘false’.

hideFreezeStatus

This uses Boolean variables to define whether the Freeze Status column is displayed in the Global and Form Summaries. If ‘false,’ the Freeze Status column will be displayed; if ‘true,’ the column will be hidden. If not set the default is ‘false’.

hideLockStatus

This uses Boolean variables to define whether the Locked Status column is displayed in the Global and Form Summaries. If ‘false,’ the Locked Status column will be displayed; if ‘true,’ the column will be hidden. If not set the default is ‘false’.

hideQueryStatus

This uses Boolean variables to define whether the Query Status column is displayed in the Global and Form Summaries. If ‘false,’ the Query Status column will be displayed; if ‘true,’ the column will be hidden. If not set the default is ‘false’.

hidePiStatus

This uses Boolean variables to define whether the Signed by PI column is displayed in the Global and Form Summaries. If ‘false,’ the Signed by PI column will be displayed; if ‘true,’ the column will be hidden. If not set the default is ‘false’.

hideDataReviewStatus

This uses Boolean variables to define whether the Data Review Status column is displayed in the Global and Form Summaries. If ‘false,’ the Data Review Status column will be displayed; if ‘true,’ the column will be hidden. If not set the default is ‘false’. For studies existing at the time of the DBP 13.0.0 release, this feature will be turned off by default.

addRecordTerm

This property defines the display text of the create record link on the study homepage. The default setting is for the link to read as ‘Enroll Patient’. The property can be set to overwrite the entire text string or you can simply overwrite the word ‘Enroll’. To overwrite the entire string, set the property to the desired display text. The following example will cause the link to be displayed as ‘Click to Screen a Subject’.

  • addRecordTerm = Click to Screen a Subject

To override only the word enroll, set the property to contain your replacement text for the word Enroll followed by {0}. The following example will cause the link to be displayed as ‘Screen Patient’.

  • addRecordTerm = Screen {0}
Note: The word ‘Patient’ can be set to ‘Subject’ by using the recordName and recordNamePlural parameters in the Application Setup tab of the DataArchitect file.


ConfirmationMessage

This property defines a text message presented to a user prior to the application of the user’s electronic signature. The message to be presented to the user should be defined as the property’s value.


ConfirmationMessage-en

This property defines the confirmation message for users with user profiles set to English. The default English Translation text shall be displayed if confirmationMessage property is not defined. The default English Translation of the signature confirmation shall read: By providing my electronic signature, I certify that I have reviewed and approved the data and I understand that electronic signatures are the legally binding equivalent of traditional handwritten signatures.

ConfirmationMessage-ja

This property defines the confirmation message for users with user profiles set to Japanese.

ConfirmationMessage-zh

This property defines the confirmation message for users with user profiles set to the Chinese.

recordLocator1

This defines the first identifier used when using the ‘chooseRecord’ permission. The Primary Identifier is the most often identifier used. The entire path to this question must be specified by this attribute. The string must be formatted as such: #form.questionID where ‘#’ signifies “start at the root.” (e.g., “#baseline.registrationForm.subjectNumber”) 

Note: As these are used to find subjects in Reconcile Record and that utility does not support all question types, please do not point this at a question that is not Text, PlainText, MultiLineText, Radio, or RadioCheckbox. Using any other question type for this locator will result in a Reconcile Record screen with no input for the question.


recordLocator2

This defines the second identifier used when using the ‘chooseRecord’ permission. The Secondary Identifier is the most often identifier used. The entire path to this question must be specified by this attribute. The string must be formatted as such: #form.questionID where ‘#’ signifies “start at the root.” (e.g., “#baseline.registrationForm.subjectNumber”) 

Note: As these are used to find subjects in Reconcile Record and that utility does not support all question types, please do not point this at a question that is not Text, PlainText, MultiLineText, Radio, or RadioCheckbox. Using any other question type for this locator will result in a Reconcile Record screen with no input for the question.


documentIds

This property can be used to specify which documents in the study’s workgroup File Manager should be included in the Study Documents widget. The documents are specified by document ID. The document ID can be found by navigating to the study’s workgroup File Manager, placing the cursor over the document link and viewing the URL associated with the link. For multiple documents use a pipe delimiter (|) between the form names. Additionally, files can be added to the Study Documents widget by checking ‘Include in Study Home Page’ checkbox on the File Properties screen in File Manager.

diffToolXXXXXPartner

Please refer to the Configuring Double Data Entry section.

diffParentXXXXXPartner

Please refer to the Configuring Double Data Entry section.

diffToolXXXXXChildrn

This property is not used in the double data entry process anymore. You might need to use property diffParentXXXXXPartner instead. Refer to the Configuring Double Data Entry section.

confirmEnrollment

This defines the use of a confirmation enrollment prompt when enrolling a new patient. If set to ‘true’ the user will be presented with a prompt asking them to confirm that they want to enroll a patient. If the user indicates that they want to continue enrolling the record will be created and the user will go to the initial form in the casebook. If the user presses cancel at the prompt, they will be taken back to the study homepage. If set to ‘false’ the user will not be prompted and the record will be created as soon as the user clicks the ‘Enroll Patient’ link. If not set at all, the default is ‘false’.

forwardToNextForm

When set to “always”, the user will always be forwarded to the “next” form when editing forms in a sequence of forms. If set to “whenStatusWasBlank”, it will only forward to the next form when the answer status was previously blank. The “forwardTo” attribute on the “Branches” and “Form Types – Definition” tab will always override this property unless it is forwarding to the parent form.

Note: In the case of dynamic forms, when a user saves a dynamic form they will always be directed to the parent form.


studyAuditDateFormat

This defines the date and time format of the audit trail used in the casebook. The default format is ‘dd/MMM/yyyy HH:mm’. The audit trail date format must include the time but this setting was provided for those users who may be used to a different date format (ie. ‘yyyy/MM/dd HH:mm’). The format settings are based on Java date and time formats.

eTrainSiteId


Note: This parameter has been disabled. Using it no longer provides value as the system it connected to is no longer part of the platform. Out eTrain modules are now part of eClinical.

This defines the eTrain Site ID. This creates a link on the study homepage that gives the user access to the Learning Management System (LMS) that provides them with training history and any web-based training being used in the study. This is the same for all studies within your sponsor. This ID must be provided by a Learning Solutions Administrator (LSA).

noRfcOnInitialBlankEntry

This property allows the designer to specify that the Reason for Change (RFC) is not required if a question is saved blank and then updated later. Example: the end user saves a form with 10 questions and one is left empty because the user does not have the information. When they come back at a separate time and update that question and this property is set to “yes”, they will not be required to enter a Reason for Change. The values are “yes” and “no”. The default is “no”.

addDynamicWhenFrozen

This property allows the designer to specify whether dynamic forms can be added to a form summary that has been frozen. If the property is set to “true” the dynamic form link will be present and forms can be added even when the form summary is frozen. If the property is set to “false” dynamic forms cannot be created from a frozen form summary. The default setting is false.

Note: addDynamicWhenFrozen enables this ability on all dynamic form summaries.

allowedDynamicTypesWhenFrozen

This property allows the designer to specify which formTypes can be created from a frozen form summary. The formTypes should be recorded in a comma separated list.

Note: This should not be used together with addDynamicWhenFrozen. Using this property allows this ability to occur only on the specific list of formTypes. If addDynamicWhenFrozen is used, this property will be ignored.

signLocked

This property allows the designer to specify whether the PI Signature can be applied to locked data. If the property is set to “true” the signature can be applied to locked data. If the property is set to “false” the signature cannot be applied to locked data. The default setting is false.

allowRandomizationOnPartiallyLockedRecords

This property allows the designer to specify whether a subject with locked or partially locked data can be randomized. If the property is set to ‘true’ the subject will be randomized even though locked data is present. If the property is set to ‘false’ the subject cannot be randomized with locked data. The default setting is false.

provideFiles_form

This property works with the File Access functionality to define which subforms are available from the dialog box. When no property is specified, all static subforms will be available by default. This option will not display ANY dynamic forms. In this example, the subforms available were added using scripts in order to display them as static forms throughout the provideFiles options.  


When the property is specified, values provided will control what appears in the dialog. Using the property provideFiles_formTypeID will set the available options for files uploaded to any instance of the formTypeID. Using the property provideFiles_formId allows the designer to specify behavior for a specific instance of a form. Various options for specifying the property value are supported. This option can display both static and dynamic forms if they are specified in the App Property.

  • Provide a comma separated list of all subform formTypes or formIDs which should be available.


  • The dialog box will list those forms by variable name:

  • Display a friendly form name name by using || in the configuration. Multiple forms can be separated with a comma or a double colon (::).
  • The dialog box will list those forms by variable name:
  • When multiple instances of the same formType are available as subforms, a single option can be configured to make the file available to all instances with a single click:

nativeFileNames

This property allows the designer to specify whether native language references will be used as file and directory names within the PDF export. If the property is set to “true” the native language references will be displayed, however, no index files or cross PDF file navigation is created. If the property is set to “false” the standard PDF configurations will be used. The default setting is false.

extendedDefaults

This property is used to enable the ability to provide default values for questions that have answer options defined on the Question Definitions Tab. To enable default values for these question types, set this property to true. Then configure each default value with the questionTypeId_defaultValue property. This property must be defined before default values can be set for the following display types:

  • Radio
  • RadioCheckbox
  • MultiCheckbox
  • Select
  • PopUpSelect
  • MultiSelect
  • Slider

questionTypeId_defaultValue

After setting the extendedDefaults property to true, each default value is set as a separate property. To set the default value for a question, enter the question’s TypeId followed by ‘_defaultValue’ for the property name. Then for the property’s value, enter the expression or value for the default value. The value should refer to the database value (not the display value) of the question. The value can be an expression that points to another data point in the casebook. In the following example, the default value for the questionTypeId ‘sex’ is set to 1, which is the expression for male.

is-id-identifier

This property is used to suppress compiler warnings related to names and IDs that the compiler does not recognize. For example, when using the absolute value command, abs, in the DataArchitect file, the compiler will give a warning during compilation. By adding the property, is-id-abs, to the App Properties worksheet as shown in the following example, the warning will no longer be displayed. No value is associated with this property, so the value column should be left blank.

trimValues

When set to true, this property removes whitespace from the beginning and end of a question value prior to saving it or evaluating dependencies. The default value for studies existing prior to September 19, 2013 is false. The default value for studies created on or after September 19, 2013 is true. Acceptable Values: true or false

maxUnrestrictedSelectLength

This property is used for questions of display type ‘Select.’ This property determines the approximate maximum number of characters that are displayed in select boxes prior to the user clicking the select box so that the options appear. The default value is 30. While this property sets the default value for all questions of type ‘Select,’ the Field Size property on the Question Types worksheet of the DA can be used to override the setting at the question level.

tabularWaitTimeInSec

When using older browser versions that are not supported by our browser policy, users can experience issues with the tabular view of forms. This property specifies the amount of time (in seconds) that the system should attempt to display the form in tabular view before prompting the user to switch to list view. The default value is 45 seconds. For more information regarding the behavior of this feature, see the Tabular Data Entry and Review page.

useLegacyHR

HR tags specified in the Group Title column of the Display tab in the DA are ignored by default. When set to true, this property causes the system to include the HR tags. The default value is false. Acceptable Values: true or false

autoCorrectDateFormat

When set to true, this property enables the automatic date format feature. When this feature is enabled and the user enters an unambiguous date in a format other than the format accepted for the question, the system will reformat the date to match the question’s expected date format. The default value is false. For additional information regarding the difference between ambiguous and unambiguous dates, see the table below. The following should be kept in mind when using this feature.

  • When the year is typed in a two-digit format and the question expects a four-digit format, the date is first evaluated as occurring in the current century (i.e. 2000). If the date is greater than the current year, the date will be interpreted to be the previous year that ended with the two-digit number. Otherwise, the most recent year ending with the two-digit number is used. For example, the user-input date of 8-22-15 is interpreted as August 22, 1915 while 8-22-14 is interpreted as August 22, 2014.
  • When the date entered is six numbers in length and contains no slashes or dashes, the date is assumed to be in the format MMddyy
  • When the date entered is eight numbers in length and contains no slashes or dashes, the date is assumed to be in the format MMddyyyy
  • If dates are entered in the MMddyyyy or MMddyy formats, the system expects the use of leading zeroes. For example, January 20, 2014 would need a leading zero for the month: 01202014
  • If the date is determined to be ambiguous (i.e. the date can be interpreted to be more than one date), the system will not attempt to reformat the date.
Date FormatAmbiguity Notes
dd/MMM/yyyyUnambiguous
dd-MMM-yyyyUnambiguous
dd/MMM/yyUnambiguous when yy is greater than the number of days in the month
dd-MMM-yyUnambiguous when yy is greater than the number of days in the month
ddMMMyyyyUnambiguous
ddMMMyyUnambiguous when yy is greater than the number of days in the month
MM/dd/yyyyUnambiguous when dd is greater than 12
MM-dd-yyyyUnambiguous when dd is greater than 12
MM/dd/yyUnambiguous when dd is greater than 12 and yy is greater than 31
MM-dd-yyUnambiguous when dd is greater than 12 and yy is greater than 31
yyyy-MM-ddUnambiguous when dd is greater than 12
yyyy/MM/ddUnambiguous when dd is greater than 12
MMddyyyyUnambiguous since all dates of length 8 that contain no slashes or dashes are expected to be in this format
MMddyyUnambiguous since all dates of length 6 that contain no slashes or dashes are expected to be in this format

 

plainTextLogChangeNo

When set to true, this property causes all questions with a display type of “PlainText” to behave as if the logChange field on the Question Types – Definition worksheet is set to “no”. This means that when the value of a PlainText question changes, the user will not be prompted to provide a reason for changing the data value. The default value for this property is false.

maxEnroll 

Added with the 1.0.3 release, the various maxEnroll related functions defined below allow enrollment thresholds to be set at the Study and/or Site level based on the defined configuration. These max enrollments are considered and applied when enrollment is attempted as part of the standard user interface, however enrollments which are added as part of an import action will not be prevented, even when defined thresholds are met. 

maxEnrollCount 

This defines the total number of enrollment records for all sites. For example, if this is set to 50, and Site A has 40, the system will only allow 10 additional to be added across all other sites. If Site B then added 8, and Site C added 2, the system would not allow any other additions at any site, since the 50 has been met.

maxEnrollCountSite 

This defines the maximum number of enrollments allowed per site for Production sites. This is considered only when maxEnrollCountSiteX (where X is the name of the site) is not utilized.   For example, if this is set to 10, each site can only enroll 10. Once Site A meets 10, the site will no longer be able to enroll. However Site B is still able to enroll until they meet 10 as well.

maxEnrollCountSiteX 

This defines the maximum number of enrollments allowed for the specified Production site, where X is the name of the site. For example, for site 101-Smith, the property would be listed as maxEnrollCountSite101-Smith. 

maxEnrollScreenFailSite

This defines the maximum number of enrollments allowed for subjects (patients) with the record status ScreenFail for all Production sites. This is considered only when maxEnrollScreenFailSiteX (where X is the name of the site) is not utilized.

maxEnrollScreenFailSiteX

This defines the maximum number of enrollments allowed for subjects (patients) with the record status ScreenFail the specified Production site, where X is the name of the site. For example, for site 101-Smith, the property would be listed as maxEnrollScreenFailSite101-Smith. 

maxEnrollRunInFailSite

This defines the maximum number of enrollments allowed for subjects (patients) with the record status RunInFail for all Production sites. This is considered only when maxEnrollRunInFailSiteX (where X is the name of the site) is not utilized.

maxEnrollRunInFailSiteX

This defines the maximum number of enrollments allowed for subjects (patients) with the record status RunInFail the specified Production site, where X is the name of the site. For example, for site 101-Smith, the property would be listed as maxEnrollRunInFailSite101-Smith. 

maxEnrollEarlyTermSite

This defines the maximum number of enrollments allowed for subjects (patients) with the record status EarlyTerm for all Production sites. This is considered only when maxEnrollEarlyTermSiteX (where X is the name of the site) is not utilized.

maxEnrollEarlyTermSiteX

This defines the maximum number of enrollments allowed for subjects (patients) with the record status EarlyTerm the specified Production site, where X is the name of the site. For example, for site 101-Smith, the property would be listed as maxEnrollEarlyTermSite101-Smith. 

maxEnrollCompleteSite

This defines the maximum number of enrollments allowed for subjects (patients) with the record status Complete for all Production sites. This is considered only when maxEnrollCompleteSiteX (where X is the name of the site) is not utilized.

maxEnrollCompleteSiteX

This defines the maximum number of enrollments allowed for subjects (patients) with the record status Complete the specified Production site, where X is the name of the site. For example, for site 101-Smith, the property would be listed as maxEnrollCompleteSite101-Smith. 

maxEnrollRunInSite

This defines the maximum number of enrollments allowed for subjects (patients) with the record status RunIn for all Production sites. This is considered only when maxEnrollRunInSiteX (where X is the name of the site) is not utilized.

maxEnrollRunInSiteX

This defines the maximum number of enrollments allowed for subjects (patients) with the record status RunIn the specified Production site, where X is the name of the site. For example, for site 101-Smith, the property would be listed as maxEnrollRunInSite101-Smith. 

maxEnrollPreScreeningSite

This defines the maximum number of enrollments allowed for subjects (patients) with the record status PreScreening for all Production sites. This is considered only when maxEnrollPreScreeningSiteX (where X is the name of the site) is not utilized. Please note that an enrolled, but untouched patient is not in PreScreening status.

maxEnrollPreScreeningSiteX

This defines the maximum number of enrollments allowed for subjects (patients) with the record status PreScreening the specified Production site, where X is the name of the site. For example, for site 101-Smith, the property would be listed as maxEnrollPreScreeningSite101-Smith.  Please note that an enrolled, but untouched patient is not in PreScreening status.

maxEnrollEnrolledRandomizedSite

This defines the maximum number of enrollments allowed for subjects (patients) with the record status EnrolledRandomized for all Production sites. This is considered only when maxEnrollEnrolledRandomizedSiteX (where X is the name of the site) is not utilized.

maxEnrollEnrolledRandomizedSiteX

This defines the maximum number of enrollments allowed for subjects (patients) with the record status EnrolledRandomized the specified Production site, where X is the name of the site. For instance for site 101-Smith, the property would be listed as maxEnrollEnrolledRandomizedSite101-Smith.

 


Audit Trail Properties

These properties were deprecated with the introduction of the Unified interface in the 13.0 release.

Charset Restriction Properties

When you work with languages that use an extended character set, you should be advised to restrict the characters that can be edited into the eClinical application. The main reason for this is the unavailability of fonts that are capable to print all available characters for the PDF files that need to be generated. It is possible to restrict the character set on the application/study and/or on the site level. Please see the Charset Restriction page for more details. These are the properties that are used for the restriction:

charset

A comma-separated list of character subset names. Please see the Charset Restriction page for available character subsets.

Note: If this property is configured and the value is not blank, property ‘useCharset’ will be ignored.


CharsetProblemA

This property allows for the alert text to be defined in the case where an input value starts with an unsupported character and the character is the only unsupported character in the input value. The default text for this alert is ‘{0} starts with an unsupported char (code {1})’. The text can be changed to match the requirements for the study. Default Text:

User Defined Text:

This must be configured in conjunction with character set restrictions. Please see the Charset Restriction page for more details. Definition of Variables: 

Note: These variables cannot be used in non-English user-defined text. {0} – This variable will change based on where the data is entered on the question. If the question value has an invalid character, ‘{0}’ will be replaced with ‘Question value’. If the Reason for Override has an invalid character, ‘{0}’ will be replaced with ‘Reason for Override value’. {1} – Every character in the system has a code associated with it. This variable will output the code of the first invalid character in the value.


CharsetProblemB

This property allows for the alert text to be defined in the case where an input value starts with an unsupported character and there exists another unsupported character in the input value. The default text for this alert is ‘{0} starts with an unsupported char (code {1}). There are {2} unsupported characters.’ The text can be changed to match the requirements for the study. Default Text:

User Defined Text:

This must be configured in conjunction with character set restrictions. Please see the Charset Restriction page for more details. Definition of Variables: 

Note: These variables cannot be used in non-English user-defined text. {0} – This variable will change based on where the data is entered on the question. If the question value has an invalid character, ‘{0}’ will be replaced with ‘Question value’. If the Reason for Override has an invalid character, ‘{0}’ will be replaced with ‘Reason for Override value’. {1} – Every character in the system has a code associated with it. This variable will output the code of the first invalid character in the value. {2} – This variable will output the amount of unsupported characters in the value.


CharsetProblemC

This property allows for the alert text to be defined in the case where an input value starts with a valid character, but there is a single unsupported character in the input value. The default text for this alert is ‘{0} contains an unsupported character at position {2} (code {1}). Valid prefix: {3}.’ The text can be changed to match the requirements for the study. Default Text:

User Defined Text:

This must be configured in conjunction with character set restrictions. Please see the Charset Restriction page for more details. Definition of Variables: 

Note: These variables cannot be used in non-English user-defined text. {0} – This variable will change based on where the data is entered on the question. If the question value has an invalid character, ‘{0}’ will be replaced with ‘Question value’. If the Reason for Override has an invalid character, ‘{0}’ will be replaced with ‘Reason for Override value’. {1} – Every character in the system has a code associated with it. This variable will output the code of the first invalid character in the value. {2} – This variable will output the position of the invalid character in the value. {3} – This variable will output the valid characters before the first invalid character in the value.


CharsetProblemD

This property allows for the alert text to be defined in the case where an input value starts with a valid character, but there are at least two unsupported characters in the input value. The default text for this alert is ‘{0} contains {2} unsupported characters, first one at position {3} (code {1}). Valid prefix: {4}.’ The text can be changed to match the requirements for the study. Default Text:

User Defined Text:

This must be configured in conjunction with character set restrictions. Please see the Charset Restriction page for more details. Definition of Variables: 

Note: These variables cannot be used in non-English user-defined text. {0} – This variable will change based on where the data is entered on the question. If the question value has an invalid character, ‘{0}’ will be replaced with ‘Question value’. If the Reason for Override has an invalid character, ‘{0}’ will be replaced with ‘Reason for Override value’. {1} – Every character in the system has a code associated with it. This variable will output the code of the first invalid character in the value. {2} – This variable will output the amount of unsupported characters in the value. {3} – This variable will output the position of the first invalid character in the value. {4} – This variable will output the valid characters before the first invalid character in the value.


defineCharset#id

This setting defines a charset, see the Charset Restriction page.

pdfCharsetBackground

This can be used as help to visualize the background of the configured characters. This setting defines a charset, see the Charset Restriction page.

PDF.FONT.ENCODING

This is the setting for the PDF font encoding. It is important to verify that the charset restriction fits to the selected font name and encoding. It can result in “invisible” (or unprintable) characters when this is not set up correctly.

PDF.FONT.NAME

This is the setting for the PDF font name. It is important to verify that the charset restriction fits to the selected font name and encoding. It can result in “invisible” (or unprintable) characters when this is not set up correctly.

useCharset

This setting defines the charset to use, see the Charset Restriction page.

Configuring PDF Archival

The PDF archival can be customized with either application properties or export parameters. Specifying a configuration value with an export parameters applies the value to the one export only. This means that different exports can use different configuration values. Please review the general documentation on PDF archival:

Keep in mind: If a configuration value applies to all of your PDF archival exports, then you should set it application property. When it applies to only one export, then configure it as parameter for the export. Export configuration parameters override application properties for the export. If you have many PDF exports and only a single one requires a different configuration, then set the general value as application property and the special value as export parameter.

Configuring Form PDF Output

The generation of form PDF output can be customized with properties.

pdfFormBaseSize

This property specifies the base font size for the output. The default size is “10″.

pdfFormLogoImage

This property can specify the path to the logo for the header of the PDF. The prefix “$webbase” is replaced with the web base directory on the server.

maxLogoHeight

This property specifies the max height of the logo in points. The default height is “57″ points.

pdfFormHeader

With this setting the text of the header can be customized.

pdfFormTimeStampFormat

This property allows the modification of the timestamp format for the form PDF output. By default the study date format is used. If that is not set the default format is “dd-MMM-yyyy HH:mm”.

pdfFormHeaderSeparator

Form PDF output is generated for a single form. As a form can be used multiple times in a casebook, it is important to display the names of parent forms as well. This setting allows modifying the layout of the display of parent forms. By default the parent names are displayed vertically on top of the form name. When this is not the desired layout, it is possible to have the parent form names displayed horizontally with a separator between them. This setting is the value of the separator to display. Depending on the design it is possible that some forms might use their own layout. You can override the default for a form type only by adding a dash and a form type id to the name of the property. Example: The property “pdfFormHeaderSeparator-demo” specifies the value to use for the “demo” form only.

pdfFormHeaderIndentation

When no separator is specified for the display of parent form names, then it is possible to specify the indention for each line. By default an indentation of 4 spaces is used. If you specify a value of “0″, then no indentation is displayed. Depending on the design it is possible that some forms might use their own layout. You can override the default for a form type only by adding a dash and a form type id to the name of the property. Example: The property “pdfFormHeaderIndentation-demo” specifies the value to use for the “demo” form only.

Applicable Other Properties for Form PDF Output

There are more properties that can affect the form PDF output. These are not specific to form PDF and they also affect other parts of the application. These properties are:

Configuring Additional Output for Trial Manager (Annotated eCRF)

There are a number of configuration properties that customize the appearance of the empty eCRF and annotated eCRF as it is generated by the Trial Manager.

pdfCrfHelpPage

By default the Index file contains a Help page with links to the Fountayn help system. This may not be desired in cases when the audience does not have access to the help system. In such cases, this property can be set to false to prevent the page from being produced.

PDF.FONT.NAME

This property specified the font name to use for the PDF CRFs to create. For Japanese output, you might use font “KozMinPro-Regular”. For Chinese output, you might use font “STSong-Light”.

PDF.FONT.ENCODING

This property specified the font encoding to use for the PDF CRFs to create. For Japanese output you might use encoding “UniJIS-UCS2-H”. For Chinese output, you might use encoding “UniGB-UCS2-H”.

pageSize

Specifies the size for the page. By default the size is “letter”. The other possible value here is “A4″ for European customers.

pageMarginLeft

Specifies the left page margin. Default value is: “54″. It is measured in points (72pts = 1 inch).

pageMarginRight

Specifies the right page margin. Default value is: “27″. It is measured in points (72pts = 1 inch).

pageMarginTop

Specifies the top page margin. Default value is: “27″. It is measured in points (72pts = 1 inch).

pageMarginBottom

Specifies the bottom page margin. Default value is: “72″. It is measured in points (72pts = 1 inch).

pdfCrfBaseSize

With this integer property you can change the font size for the documentation. The default is a font size of ’10′, which means 10 pt fonts for the majority of items. Some information is shown is a larger font depending on the base font size. The smallest possible base font size value is ’6′.

pdfCrfTimeStampFormat

Specifies the time format for the PDF CRF file creation.

studyDateFormat

This is the study date format use for different purposes. When no “pdfCrfTimeStampFormat” is set, then this format is used for the PDF CRF files. When both settings are not set the following format is used: dd-MMM-yyyy HH:mm

pdfCrfLogoImage

This setting allows the specification of a different than the default logo image on the front pages of the PDF files. When you want to use an image from Fountayn server, which is strongly recommended, then you need to use the term “$webbase” for the currently active environment. As example you can use “$webbase/images/gears.gif”. When you do not have the image for your company, you should contact your project manager or the help desk to get the image onto Fountaynservers.

maxLogoHeight

Specifies the maximum height of a logo image for the front page measured in points. The default is ’57′.This is a value of about 0.8 inch or 2 cm. Remark 72 points are one inch.

pdfCrfIndexFile

Specifies the name of the index file. By default the index file is named “Index”. Do not add the “.pdf” suffix here as it is appended automatically.

pdfCrfFileName

Specifies the name of the non-annotated CRF file. By default this is names “Crf”. Do not add the “.pdf” suffix here as it is appended automatically.

pdfCrfFileNameAnnotated

Specifies the name of the annotated CRF file. By default this is names “CrfAnnotated”. Do not add the “.pdf” suffix here as it is appended automatically.

pdfCrfExportSubforms

By default each form contains a list of the subforms. You can set this property to “false”, when you do not want to see the subform list per form.

pdfCrfWebGlossary

The annotated CRF contains a number of annotations for forms and questions. By clicking on one of these items the user is directed to a web link that contains information about the clicked item. This way the answer – “What is this” – can be easily answered by the user itself. When you do not want this default behavior, you can set this setting to “false” and no links to the web glossary are added to the document.

This property determines whether links from the index file to the non-annotated CRF file are added. It is required that both the index and the non-annotated CRF documents are located in the same directory. As you know, all files are delivered in a ZIP archive. When you click on the index only, then the index file is extracted to a temporary directory and the links to the CRF document will not work in this case. You should extract all files from the archive before following the links. By default the links are added and you are redirected to the form in the CRF, when you click on the name of the form. Disable this feature by setting this property to “false”.

This property determines whether links from the index file to the annotated CRF file are added. It is required that both the index and the annotated CRF documents are located in the same directory. As you know, all files are delivered in a ZIP archive. When you click on the index only, then the index file is extracted to a temporary directory and the links to the CRF document will not work in this case. You should extract all files from the archive before following the links. When the annotated link feature is enabled, then a “…” is displayed behind the form name. Clicking on this “…” will redirected to the form in the annotated CRF. This feature is enabled by default. Disable this feature by setting this property to “false”.

pdfCrfStudyStructure

With this property you can specify whether you want or do not want a form architecture in the non-annotated CRF printout. The form architecture can be used to navigate in the file in addition to the existing bookmark trees. By default the form architecture is created.

pdfCrfAnnotatedStudyStructure

With this property you can specify whether you want or do not want a form architecture in the annotated CRF printout. The form architecture can be used to navigate in the file in addition to the existing bookmark trees. By default the form architecture is created.

pdfCrfStudyStructureOnTop

When you create a form architecture, then this property specifies the place, where the bookmark is located. By default and when this property is “true”, the form architecture bookmark is located on top of the bookmark list. Set this property to false, when you want the bookmark for the form architecture at the bottom of the list.

pdfCrfHeader

With this setting you can customize the header for the non-annotated CRF file, which is shown on the front page. It is possible to use the following constants that are exchanged with correct values when the document is created: [STUDYID], [APPLICATIONVERSION], [LOGIN], [TIMESTAMP].

pdfCrfHeaderAnnotated

With this setting you can customize the header for the annotated CRF file, which is shown on the front page. It is possible to use the following constants that are exchanged with correct values when the document is created: [STUDYID], [APPLICATIONVERSION], [LOGIN], [TIMESTAMP].

study

The value of this property is written for the code [STUDYID] in the headlines.

pdfCrfFormArchMultiColor

By default the index and form architecture use dark gray, gray and black to better visualize the different level of forms. You can disable this behavior by setting this property to “false”. In this case all text is written in black.

pdfCrfFormArchSequenceNumbers

By default the index and form architecture use index numbers in front of forms of the same level to allow easier identification of related froms even across multiple pages. You can disable this behavior by setting this property to “false”. In this case no sequence numbers are written.

pdfCrfFormArchIndentation

The value of this property specifies the indentation for forms of different levels in the form architecture and the index. The default value is ’30′. The value is measured in points. 72 points make one inch.

pdfCrfFormArchItemNumberHeight

Specifies the font size for the item numbering in the index and form architecture.

correctApostrophe

The apostrophe (character \u0027) is not displayed correctly with Asian language iText output. Unicode has a preferred apostrohe: \u2019. By default this problem is fixed. If the fix should result in other problem, then it can be disabled by setting this property to “false”.

pdfDefaultFontFileName

This is the specification of the default font file. Do not change this unless you are explicitly instructed to do so.

Allow For Auto-Query Resolution

With auto-query resolution, queries can be automatically advanced to either the Answered or Closed status based on the change made to the queried question. For example, if a query is created that requests information from a subject and the subject changes the data related to that query, the query status will automatically change from ‘New’ to ‘Closed.’ The following properties must be defined for auto-query resolution.

updateQueryWhenValueChange

This property enables query resolution. Its value can be set to either ‘closed’ or ‘answered’ depending on how the status of the query should change.

updateQueryWhenValueChangeComment

This defines the response text that will be automatically inserted into queries that are auto-updated to answered or closed. For example, the value may read: “Query has been addressed by changing the question response.” This parameter can be used if the updateQueryWhenValueChange property is enabled.

updateQueryWhenValueChangeByImport

This is only needed when the study makes use of both the auto-query resolution feature and at least one data import configuration. The property defines whether or not auto-query resolution will occur during the processing of a data import. The value should be set to ‘true’ to enable auto-query resolution for data imports and set to ‘false’ otherwise.

Display Inline Queries

Within the system, queries can be displayed directly on the form in a  bar. Depending on each Role’s privileges, the query can also be closed, answered or reopened directly on the form.


updateQueryECRF

This property enables inline queries when added to the App Properties worksheet. Its value is the list of the roles separated by a double pipe ‘||’ that are permitted to view the inline queries. As an example, the following configuration allows four different roles (Coordinator, Investigator, Monitor and FTNY Debug) to view inline queries.

hideAnswerStatusECRF

When set to true, this property hides inline, answered queries from users that are not allowed to close or reopen queries. Users with permission to close or reopen queries (the “updateQuery” action as well as the “set” query permission for either reopened or closed queries) will still be able to see the inline, answered queries. Be aware: this property does not hide information regarding the answer metadata status. It only hides inline, answered queries. Acceptable Values: true or false (true by default) In the example below, the Coordinator role does not have the updateQuery action permission or “set” query permissions . Therefore, when hideAnswerStatusECRF is set to true, the Coordinator does not see the inline, answered query.

displayClosedQueries

When set to true, any role indicated in the updateQueryECRF property with the ability to view closed queries will see query text for closed queries inline.

Restrict Roles Allowed to Close or Edit a Query

By default, all roles with query edit permissions can update or close queries. Use the property below to restrict this functionality.

queryCreatorEditOnly

When this property is set to ‘true’, a query can only be edited or closed by a user with the same role as was used to create the query. For example, if set to true, queries created by a Data Manager can only be edited or closed by users with the Data Manager role. When set to ‘false’, all users with the query edit permission can update or close all queries. The default value is ‘false’.

Specify Default Reason for Override and Reason for Change

The Reconcile Utlity and drug assignments triggered by scripts can cause values to update or alerts to trigger on a form. Use the properties below to specify the Reason for Override and Reason for Change text that should be used in each case. If not specified, the indicated default text will be used.

alertReconcileRFO

When an alert is triggered by the execution of the Reconcile utility, the Reason for Override will be populated with the value of this property. If the property is not specified, the Reason for Override will state “Automated Reconcile”.

assignmentReconcileRFC

For assignments programmed in the dataArchitect file updated through the execution of the Reconcile utility, the Reason for Override and Reason for Change will be populated with the value of this property. If the property is not specified, “Automated Reconcile” will be populated.

drugAssignmentRFO

When a drugAssignment command in a script sets the value on another form, the Reason for Override on any triggered alerts on the updated question will be populated with the value of this property. If the property is not specified, the Reason for Override will state “Assignment Script”.

scriptAssignmentReconcileRFC

For script-based assignments updated through the execution of the Reconcile utility (with Process Assignments), the Reason for Override and Reason for Change will be populated with the value of this property. If the property is not specified, “Script Assignment” will be populated.

If a study does not use all system functions, the metadata related to these functions can be hidden in the system. To hide an unused function, set the appropriate App Property from the following list to true:

  • hideAnswerStatus
  • hideSdvStatus
  • hideLockStatus
  • hidePiStatus
  • hideAlertStatus
  • hideFreezeStatus
  • hideQueryStatus
  • hideDataReviewStatus

With these App Properties, metadata related information can be hidden in the following systems:

  • Record Manager
  • Form Manager
  • Questions Manager
  • Form Statistics
  • Data Point Report
  • Averages Report
  • Patient Management
  • Trial Summary

For example, before any of the App Properties are set to true, the metadata related information is displayed in the Record Manager.


Then the Data Architect file is updated to include the new metadata related App Properties.

Since hideQueryStatus is set to ‘true’ in the Data Architect file, the Query Status will no longer be visible.


Configure Date Picker Ranges

On questions with date values, a standard calendar is presented to the user. By default the date picker only covers a 10 year range back from the current date. This can be customized in the DA. By adding a property in the App Properties worksheet, you may define the range of dates you want the picker to display for a given question. To do this enter into the Name column “yearRange-” followed by the name of the question you are applying the range to. In the Value column, two numbers should be entered in the following form: “[+-]number:[+-]number”. These numbers are offsets from the current year that define the range covered by the picker. So in the year 2013, the range “-13:+7″ would cover 2000 – 2020.

This property would establish for the question called ‘dobdt’ (date of birth) a date range for its date picker beginning 31 years before the current year and ending 18 years before the current year.

Configuring Metadata Status Needs Properties

A study may be configured to need certain metadata-related actions based on triggers that are themselves metadata statuses. The Managers can then display this information to users in the Progress Bars. For example, the study may be configured to need Data Review once a form or question has the ‘Completed’ status applied to it. This is performed using the needsXXX property, where “XXX” is the name of the metadata status, and the value assigned is the metadata status that triggers the action requirement. Assigning a value of ‘none’ flags the action as optional for the workflow visually established with these properties. A Form will not show a Needs parameter until the dependent form has a full status. In the example below, the study has “needsDataReview” configured to “completed”. When a form is changed to “complete”, the Data Review Status changes to “Review Needed”


Note: These properties do not restrict the workflow for forms or the actions that can be performed on them. Rather, they are used to help guide users as to when a form is ready for the next step in the process.
Note: The property values are case-insensitive. This means that to specify the “completed” status, the system will accept both “Completed” and “completed”.


needsSign

This should be configured in the AppProperties worksheet, and has the following possible values: InProgress, Completed, Reviewed, Frozen, Verified, Locked, and None.

needsFreeze

This should be configured in the AppProperties worksheet, and has the following possible values: InProgress, Completed, Reviewed, Verified, Signed, Locked, and None.

needsLock

This should be configured in the AppProperties worksheet, and has the following possible values: InProgress, Completed, Reviewed, Frozen, Verified, Signed, and None.

needsSDV

This should be configured in the AppProperties worksheet, and has the following possible values: InProgress, Completed, Reviewed, Frozen, Signed, Locked, and None.

needsDataReview

This should be configured in the AppProperties worksheet, and has the following possible values: InProgress, Completed, Frozen, Verified, Signed, Locked, and None.

Configuring Partial Editing

See the page on Partial Editing to learn how to configure this feature.

This feature allows for forms to be hidden in the Form Links Tree for a particular role or across the trial. Note that this feature does not restrict access or hide forms in the form summary and managers. This feature only hides forms in the Form Links Tree.

hideInTree

Accepts a comma-separated list of form types. This property hides all the forms specified in the list from all roles for which the hideInTreeRoleName is not configured.

Note: If a role-specific setting is made using the hideInTreeRoleName property, only the role-specific setting is active for that role. The general setting will not apply to the role. See the additional example for further information.


hideInTreeRoleName

Accepts a comma-separated list of form types. This property hides all forms specified in the list from the specified role.

Note: If Role Selection is not enabled and you are assigned multiple roles, you can be granted access to a form through any of your assigned roles.

Additional Example

In the following example, the Data Manager role can see all forms in the Form Links Tree except for the Enrollment and Demographics forms. Note that the Data Manager can see the Pregnancy form because this form is not included in the Data Manager’s specific hideInTree property.

Form Preprocessing

You can now configure the system to delay form preprocessing until you save the form. Preprocessing consists of the firing of alerts including required and optional reason for override, format alerts, ‘requires correction’ alerts, ‘triggered by’ scripts, regular and custom dependencies, visibility logic, assignments, script assignments, and local lab ranges and units. The new application property (PreprocessOnSave) provides for rapid data entry or batch processing of data entry. The values are true or false (default=false) and consists of the following entries with definitions:

Configuring Blank Edit Check Text

preferredEntryAlertText

This property allows the configuring of the alert text when the Blank Edit Check is defined as Preferred.

requiredEntryAlertText

This property allows the configuring of the alert text when the Blank Edit Check is defined as Required.

Configuring Question Visibility by Role

Use the following properties to configure role-based question visibility on a form.

dynamicPermissions-formType

This property activates the use of a Dynamic Permissions for the specified formType. No value is needed.

questionId.editable

This property specifies the roles able to edit the referenced questionId, based on the property value. For the value, use the user.hasRole(‘RoleName’) expression to designate which role should have the ability to edit the indicated question. In cases where multiple roles should be enabled to edit the question, combine the expressions using ‘OR’, such as ‘user.hasRole(‘X’) OR user.hasRole(‘Y’)’. This property should be specified for every question on the form that should be manually editable. It does not need to be specified for PlainText questions.

questionId.visible

This property specifies the roles able to view the referenced questionId, based on the property value. For the value, use the user.hasRole(‘RoleName’) expression to designate which role should have the ability to view the indicated question. In cases where multiple roles should be enabled to view the question, combine the expressions using ‘OR’, such as ‘user.hasRole(‘X’) OR user.hasRole(‘Y’)’. Questions that should be visible to all roles do not need to be configured.

Note: QuestionTypes that are hidden by role should have a 'Blank Check' value of 'None' (or field left blank) and should not have any dependencies configured for them.


Note: Making questions visible by role does not impact question counts for the forms (in the form summary) and does not restrict visibility of the question value in exports or managers. 


Note: Both questionID visible and questionId editable need to be configured in conjunction for these properties to properly work.


Adjudication Properties

See the Adjudication Design page for information on properties related to adjudication functionality.

Script Caching Properties

These properties modify the default script handling of the system. Scripts that repeatedly reference the same question or type ID, are designed against FTYN best practices. These scripts in some circumstances may result in performance issues. In this case the below properties can be used to alter system scripting behavior which may result in performance improvement for these cases.


scriptsCacheTypesDuringRequest


This property allows the system to store question and type ID's used in the execution of scripts in cached memory. In some cases where scripts repeatedly reference the same question or type ID in their execution this App Property when added to a trial and set to 'true' may offer significant performance improvements in the time to execute such scripts.


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