Summary

This article covers the 13.0.0 DBP Release notes. 



Welcome to the DATATRAK Business Platform 13.0.0 Major Release!

DBP 13.0.8 – December 6, 2013

  • 26906: Calculation used to determine average time from expected Visit Date to data entry occurring does not work in all cases
  • 29103: Refactor Cross Trial Summary
  • 30316: synchonization needed for com.clickfind.dataCollector.fileRegistry.Registry
  • 30883: SMTP server switch
  • 31126: Script language: Converting a partial date question to a date or partial date fails during preprocessing
  • 31128: Its possible for duplicate query display IDs to be created
  • 31300: Manually changing the user’s course status will not trigger the UI conversion
  • 31419: Long question text wraps under the icons
  • 31421: Long answer option text causes the question control to wrap under the question text
  • 31441: RFC required for no change and results in no audit entry
  • 31449: Prerequisite custom action should be executed when exemption is added
  • 31475: DBP 13.0.8 Release Notes
  • 31480: Loading DATATRAK Trial manager takes long time and triggers thousands of database queries
  • 31516: Include eSignature message on eCRF

DBP 13.0.7 – September 26, 2013

  • 29335: ‘Select All’ checkbox on form base view sub form table checks all boxes in form
  • 29980: <HR> Tags Not Being Respected
  • 30190: Saving form clears signature on subforms
  • 30191: Questions should clear their signature value when data is changed
  • 30795: Tabular View Row/Column Alignment with Alerts
  • 30825: Selected values are not displayed properly due to autotrim
  • 30857: this.size does not work during preprocessing
  • 30858: Endless loop in form forwarding under special condition
  • 30877: Visibility of answered query on the eCRF should not depend on permission to answer
  • 30898: DBP 13.0.7 Release Notes

DBP 13.0.6 – September 10, 2013

  • 30194: Optimize the evaluation of math operations in the expression language
  • 30556: Utility to identify and resolve issues with query sequencing
  • 30596: Refresh the queryID property prior to allocating a new query display id
  • 30656: DBP 13.0.6 Release Notes
  • 30700: Do not process untouched questions on the target form, when an assignment to a single question of the target form is made

DBP 13.0.5 – August 9, 2013

  • 29571: Assignments to plain text questions are not visible with DT Debug role
  • 29698: Schedule Manager column widths in non-english languages are not balanced
  • 29833: Database Exceptions regarding invalid column
  • 29893: DCFormType can add double items under race conditions
  • 29919: Modified Subjects Widget transaction and data structure issues
  • For more information, see the Widgets help page.
  • 29938: Change the source for last login date in Enterprise Manager
  • 29939: Change the source for last login date on Record Status Widget
  • 29941: Retire the lastlogindate and onlineaddress columns from the Login table
  • 29944: Correct access to resentInfo.vm email template
  • 29966: Script assignment fails with dependent questions
  • 30022: Add ability to edit description field for drug assignments
  • Trial Design – Roles
    ActionsActions RequiredScreens Required
    Inventory – Edit Assignment DescriptioneditDescription

    For more information on configuring this feature, see the uIRT Roles help page for the Unified and Classic interface.
    For more information on using this feature within the system, see the Randomization Managers help page for the Unified and Classic interface.

  • 30023: Drug assignment of amount 0 actually assigns drug
  • 30037: Change to ‘accessChange.vm’ Japanese version email template required
  • 30043: Add language code to email trigger recipient
  • Trial Design – Email Triggers

    Note: This feature should only be configured when there is a need to send emails in different languages
    Beside the Email Address field, add a new column called “Locale”
    Possible Values: ‘ja’ for Japanese, ‘zh’ for Chinese, ‘zh_TW’ for traditional Chinese or ‘en’ for English

    Configuration IDEmail Trigger EventServerDC Object TypeDC Object IDEmail Subject
    1activatedProductiontool15601Subject Activated
    Email AddressLocale
    stan.lee@study.comzh
    ron.swanson@study.comja

    For more information, see the Email Triggers help page for the Unified and Classic interface.


  • 30092: DBP 13.0.5 Release Notes
  • 30093: Update uIRT manual for DBP 13.0.5
  • 30094: Update Widgets manual for DBP 13.0.5
  • 30123: Empty questions / access to configuration data

DBP 13.0.4 – July 11, 2013

  • 29567: Alerts with the same violation ID are not displayed correctly in the new UI after save
  • 29741: License agreement screen is displayed without styling for users viewing the new UI
  • 29743: DTLC Link in Edit Security Question Page Is Incorrect
  • 29839: Issue with subset export
  • 29871: Batch reading occurs for all questions under the records in the record manager
  • 29885: Users with no languageCode cannot access Shipment Manager
  • 29897: The date on the desktop is UTC and should be user specific
  • 29932: DBP 13.0.4 Release Notes

DBP 13.0.3 – July 3, 2013

  • 29739: DB property ui2012 is not checked during DA compilation
  • 29750: ‘Password Expired’ page is not displayed properly if user’s account set to Classic UI
  • 29757: Security questions are disabled when accessing profile from Enterprise Manager
  • 29768: Data Genie component links are shown with incorrect color in IE
  • 29800: ExcelWriter can skip over values due to a POI library bug which can produce a lot of logs
  • 29804: Invalid Contact Question Content is resulting in stack traces
  • 29806: dA decompiled from TM cannot be compiled/published once edited in excel
  • 29809: Required alert on protocol stops changes to protocol name once the cvs path is set
  • 29822: DBP 13.0.3 Release Notes

DBP 13.0.2 – June 26, 2013

  • 29790: DBP 13.0.2 Release Notes
  • 29792: Modify metadata count calculations on Classic UI

DBP 13.0.1 – June 25, 2013

  • 29752: Script processing permission modification
  • 29755: Missing permissions causes reports to be inaccessible
  • 29764: MultiCluster invalidation needs to be tuned
  • 29767: DBP 13.0.1 Release Notes

DBP 13.0.0 – June 22, 2013

The 13.0.0 Major Release contains some great enhancements that are certain to improve your eClinical experience. The changes in this update are grouped into the following sections:

24471 – Miscellaneous Bugs and Enhancements

15122: EULA Acceptance Date not in user export

Clinical ERP Feature Correction
When running an export out of Enterprise Manager, the EULA acceptance date is not populated, even when the user has accepted it.

Also, the portal name does not appear to be exporting as well.

16692: Add error check to make sure the restock level is always larger than the threshold

uIRT Feature Correction
Add an error check to make sure the restock level is always larger than the threshold.

17215: The Application History export should show local time

Clinical ERP Feature Correction
To be consistent with all other reports/exports out of Enterprise Manager, the Application History export should show local time, not server time.

17236: Exported timestamps are not consistent

uEDC Feature Correction
Date and time data exported from the system into Text, Excel and SAS formats should be formatted to the user’s timezone as specified in their profile, and should include the time zone specification at the end of the date and time information. The time zone specification should be the fully spelled out timezone, not the abbreviation.

23441: Configuration/Exporting of SAS Variable Lengths Outside of Writer Parameters

uDesign Feature Enhancement
A configurable property should be created within the Data Architect that allows the setting of a manual length for a SAS variable similar to the ‘length_fieldName’ SAS writer parameter. This functionality, however, should exist within the Question Types – Definition table, creating a new question type attribute that stores this length value. The default formatter parameter controlling this property should be such that these length values are included in a SAS export if this property is configured and if the question type does not employ the ‘length_fieldName’ writer parameter.

Trial Design – Question Types

Add a new column called “Length”
Possible values: Any integer value

questionTypeIdQuestion TextData TypeDisplay TypeDate FormatAnswer Options / Default ValuelogChangelogAlertlogSkipInvalid Format AlertHelp TextField SizeLength
commentComment:StringMultiLineTextyesRequiredyesOptionalno9

Trial Design – Exports
SAS Formatter Parameter Name: exportCustomLengths
SAS Formatter Parameter Value: true or false (false by default)

Param NameParam Value
exportCustomLengthstrue

Additional Notes

  • If combineFormTypes is set and two question types share the same label or question alias, they need to have the same Length.
  • Question types with the length_fieldName property in use will not be truncated.
  • Value pairs generated by includeDecodeFile are also truncated by this feature.
  • If the SAS writer parameter, adaptiveLength, is set to true, values will not be truncated.
  • The ‘Length’ formatter truncates all values including number values. To round number values, the SAS writer parameter length_fieldName should be used.
  • If showDisplayValues is also configured for the export, the display column will be the same length as the length set in the Question Types – Definition spreadsheet

For more information, see the DTLC pages on Formatter Parameters in the Classic and Unified interface and Question Types for the Classic and Unified interface.

23442: Configuration/Exporting of Variable Labels

uDesign Feature Enhancement
A configurable property should be created within the Data Architect that allows the setting of a label for a column header within an export table. This functionality should exist within the Question Types – Definition table, creating a new question type attribute that stores this label value. The default formatter parameter controlling this property should be such that these labels are included if the property is configured. This property, in effect, replaces the value of the column header. In effect, we can combine export columns based on label if configured while previously this could only be done if two forms contained a common question type. This will also be useful in the exporting of data from the SAS platform since SAS variable names need to be less than eight characters in length.

Trial Design – Question Types
Add a new column called “Label”
Possible values: Any string that defines a custom label for a question

questionTypeIdQuestion TextData TypeDisplay TypeDate FormatAnswer Options / Default ValuelogChangelogAlertlogSkipInvalid Format AlertHelp TextField SizeLabelLength
scnnumScreening Number:StringTextyesRequiredyesOptionalnoScreen Num10

Trial Design – Exports
Formatter Parameter Name: exportCustomLabels
Formatter Parameter Value: true or false (true by default)

Param NameParam Value
exportCustomLabelstrue

Additional Notes

  • If using the label in a SAS export, be sure that the label is less than 32 characters in length.
  • Be careful not to give two question types on the same form the same label. Otherwise, a conflict between the question values can occur.
  • If modifyColumnCasing, columnUpperCase or columnLowerCase are configured, they will change the casing of the label
  • If showDisplayValue is also configured, the name of the column will be the Label set on the Question Types worksheet followed by ‘_display’
  • When using combineFormTypes, columns can be forcibly combined using a common label for the question types.
  • When using length_fieldName for a question with a label, the fieldname should be the label rather than the question type id.

For more information, see the DTLC pages on Formatter Parameters in the Classic and Unified interface and Question Types for the Classic and Unified interface.

uEDC Feature Enhancement
Remove ‘*’ from search. Entering a term into the search box should return anything containing that term without the need to specify the ‘*’.

24930: Extra Space After Password String In Japanese Forgotten Password Email Template

uDesign Feature Correction
The Japanese version of the email template used to notify users of a password change associated with a forgotten password contains a space after the string that represents the password. This space makes it difficult for users to copy and paste the password from the email into the user login page. The space needs to be removed.

25131: Update Company Logo in Visual Architect

uDesign Feature Enhancement
Update the DATATRAK logo in Visual Architect so that it matches the system logo.

25379: Create combined role structure for export data

uEDC Feature Correction
The export data shold be saved in a combined roles’ folder instead of individule role’s folder. This change is needed for the new UI.

25381: Change the structure for saving import data

uEDC Feature Enhancement
All imported data should be saved under each import folder and the role’s folder should be removed. All imported data should be saved and the Depth attribute should be retired.

Trial Design – Imports
The “Depth” attribute is no longer used in the Unified interface.

25774: MS Excel Export Limited to 65,000 Rows

uDesign Feature Enhancement
The current MS Excel file usage is limited to 65,000 rows. Update export file type to support at least 1M rows.

25805: Trim question values to remove leading and trailing white space characters

uEDC Feature Enhancement
Question values should be trimmed to remove standard whitespace characters from the beginning and end prior to saving them or evaluating dependencies.

Trial Design – App Properties

For studies existing prior to September 19, 2013, this feature will be turned off by default with the trimValues property set to ‘false.’ For studies created on or after September 19, 2013, this feature is set to true by default. To enable this feature for existing studies, this property must be set to true.

NameValue
trimValuestrue

For more information, see the App Properties page for the Classic and Unified interfaces.

25928: Restrict long processes so that only a set maximum can be executed at a single time

System Feature Enhancement
Long processes are defined as occurrences of Exports, Imports and Reconcile. These processes will be queued for execution instead of immediately executed upon user request. A predetermined number of long processes will simultaneously execute, and any requests beyond that predetermined number will be queued until one of the executing long processes completes, and then immediately begin.

26046: Improve the class loading for the XML framework

System Feature Enhancement
The class loading for the XML framework searches for classes at multiple places, many times. This needs to be improved.

26628: Update Data Architect template to include all options for enterKeyAction on Application Setup tab

uDesign Feature Enhancement
In the Data Architect Template on the Instructions tab, the ‘enterKeyAction’ item under Application Setup should describe ‘none’ as another option for that setting.

26817: Multiple Submissions of Signature Action are Permitted

uEDC Feature Correction
A metadata signature can be applied multiple times from the clicking the signature process log in screen. The application of multiple signature attempts occurs when the user clicks the ‘Sign’ button multiple times before the signature application process is completed. If the log in credentials are entered correctly, the ‘Sign’ button should be disabled after the initial click.

26858: Update Java Version to Java 6

System Feature Enhancement
Update the DBP Java platform version to Java 6.

27000: Blank alert firing on non-blank data

uEDC Feature Correction
Previously set restricted questions will not be submitted under restricted view. This causes blank alert firing for non-blank data.

27733: Address problem with linking from the Alert Manager to the form with the alert

uEDC Feature Correction
For the old UI: There is a problem with the links from alert manager to the forms because the roleInstanceID parameter is missing in the base url.

28537: Update ManagementServlet Access

System Feature Enhancement
Update ManagementServlet access per current tech team personnel

29048: Update the exportDeletedForms parameter support for PDF Export

uDesign Feature Enhancement
The PDF export should include question audits on deleted forms if the exportDeletedForms parameter is true.

24120 – Partial Metadata

23647: Configurable Partial Metadata Plan

uDesign Feature Enhancement
Support the configuration of ignored data fields within a plan, where a study can have multiple plans and can change from one plan to another based on an expression throughout the course of a trial. Each record will belong to a single plan at any one time.

Database fields will need to be added to the record to track which plan a record is participating in.

Additional database fields will be required on questions to track which items are participating in the plan. A column will be needed for each metadata status supported by this feature: SDV, Signature, Data Review

23648: Plan Reconciliation Utility

uEDC Feature Enhancement
A Mid study change utilty that will be responsible for reconciling the “metadata required” fields for existing records and the definition of their plans provided by the Data Architect configuration. i.e. if fields are added or removed from a plan, then the fields for existing records need to be updated to match the “new version” of the plan.

NOTE: A metadata recalculation will be needed after the utility is run.

Trial Design – Roles

ActionsActions RequiredScreens Required
metadata – reconcile plansreconcileMetaDataPlans

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23649: Record/Plan Association Utility

uEDC Feature Enhancement
A utility will be needed to move a record from one plan to another. i.e. Suppose that two plans exist for SDV, a plan A with a form set A requiring SDV, and a plan B with a form set B requiring SDV. If a record is current set to plan A, then this utility should allow for the record to transition to plan B, i.e. the forms in set A that are not in set B will have their “SDV required” fields set back to “not required” and the forms in set B that were not already set as required will be adjusted to now be required.

NOTE: A metadata recaluclation will be needed after the utility is run.

Trial Design – Roles

ActionsActions RequiredScreens Required
metadata – change planschangeMetaDataPlans

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23650: SDV Plan Association Recorded In Record Level Audit

uEDC Feature Enhancement
The record level audit detail should be updated to record any and all assocaitions with an SDV plan.

23651: Signature Plan Association Recorded In Record Level Audit

uEDC Feature Enhancement
The record level audit detail should be updated to record any and all assocaitions with an Signature plan.

23652: Data Review Plan Association Recorded In Record Level Audit

uEDC Feature Enhancement
The record level audit detail should be updated to record any and all assocaitions with an Data Review plan.

23653: Select SDV plan for a patient (Static plan)

uEDC Feature Enhancement
When a record is created, select the SDV plan based on plan expression evaluation.

23654: Implement SDV status roll up (Static plan)

uEDC Feature Enhancement
Support the updating and roll up of SDV Statuses based on the SDV Plan.

23655: Implement utility to change SDV plan (Static Plan)

uEDC Feature Enhancement
Implement a utility to allow user to change the SDV plan for an existing patient.

Trial Design – Roles

ActionsActions RequiredScreens Required
metadata – change planschangeMetaDataPlans

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23656: Select signature plan for a patient

uEDC Feature Enhancement
When a record is created, select the Signature plan based on plan expression evaluation.

23657: Implement Signature status roll up

uEDC Feature Enhancement
Implement how to update form signature status and roll up signature status based on signature plan.

23658: Implement utility to change signature plan

uEDC Feature Enhancement
Implement a utility to allow user to change the signature plan for an existing patient.

Trial Design – Roles

ActionsActions RequiredScreens Required
metadata – change planschangeMetaDataPlans

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23660: Record and Maintain Audit Detail for Data Review Status

uEDC Feature Enhancement
All Data Review status changes should be tracked within the applicable question, form and record level audit trail.

23661: Select data review plan for a patient

uEDC Feature Enhancement
When a record is created, select the data review plan based on plan expression evaluation.

23662: Implement data review status roll up

uEDC Feature Enhancement
Implement how to update form data review status and roll up data review status based on data review plan.

23663: Implement utility to change data review plan

uEDC Feature Enhancement
Implement a utility to allow user to change the data review plan for an existing patient.

Trial Design – Roles

ActionsActions RequiredScreens Required
metadata – change planschangeMetaDataPlans

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23664: Expand Scripting Language to Support Calculating Quality Factors

uDesign Feature Enhancement
Scripting language needs to have commands added for calculating quality factors.
The following values should be available via scripting language commands:
Data points entered
Data points SDV’d
Queries that caused data change
Default User Quality Score.

Trial Design – Scripts
User Quality Script Commands:

  • userDataPoints – The number of data points entered by the user
  • userDataPointsChangedByQuery – The number of data points associated with a user that were changed by a query
  • userSDVDataPoints – The number of data points entered by the user that have been SDVed
  • userQualityScore – The user’s quality score

Examples

The following script returns the user quality score.

<script scriptId='qualityScore' >
<body>
<s:userQualityScore/>
</body>
</script>

The following script returns a custom score.

<script scriptId='customScore' >
<body>
<s:if>
<s:gte>
<s: userSDVDataPoints />
<s:number value="100"/>
</s:gte>
<s:divide>
<s:userDataPointsChangedByQuery/>
<s: userDataPoints />
</s:divide>
<!--Score is not valid if data points < 1000 -->
<s:number value="500"/>
</s:if>
</body>
</script>

See the following DTLC pages for additional information on each command:
Unified: userDataPoints, userDataPointsChangedByQuery, userSDVDataPoints, userQualityScore
Classic: userDataPoints, userDataPointsChangedByQuery, userSDVDataPoints, userQualityScore

23665: Selection of Form For Dynamic SDV Plan

uEDC Feature Enhancement
When data is entered on the form for the first time by a user the decision will be made on selection of form for inclusion in the dyanmic SDV plan.

23666: User Considerations for Quality Factors

uEDC Feature Correction
The user who enters the first data on the form, will be used for any user quality score that is a factor of tier selection within the dynamic SDV plan.

23667: Manual Override of SDV Selection

uEDC Feature Enhancement
Permissions should be added to allow the user to manually mark items as ‘Requires SDV’.

Trial Design – Roles

ActionsActions RequiredScreens Required
metadata – require SDVrequireSDV

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23668: Plan Association At Record Level

uEDC Feature Enhancement
Plan will be tracked at the record level.

23669: Factors for Tier Selection

Clinical ERP Feature Enhancement
The following are factors thats should be available for tier selection:
User Quality Score
Disproportionate AEs
Disproportionate PDs
Visit the form is associated with.

23671: Abillity To Specify If A DataArchitect Property Overrides A Database Property

System Feature Correction
A field needs to be created for database driven properties. Currently database properties always override Data Architect properties. This new field should allow for database properties to specify the override behavior.

23672: Record User Quality Score

Clinical ERP Feature Enhancement
Implement mechanism to record user quality score

The following factors should be tracked with regards to a user quality score:
Data points entered
Data points SDV’d
Queries that caused data change

The default user quality score should consist of:
The ratio of Queries that caused data change to data points SDV’d.
This ratio should only be considered valid if data points SDV’d is >= 200
The ratio should be scaled so that values range from 0 to 100.

23673: Display User Quality Score

Clinical ERP Feature Enhancement
Display the user quality score in enterprise manager

23675: Select Questions that Do Not Require SDV

uDesign Feature Enhancement
Select the Questions that do not need to be marked SDV for each plan in the Question Layout tab.

Trial Design – Question Layout
After configuring an SDV plan, questions can be marked as not required for SDV by entering ‘No’ in a new row called “Plan_” followed by the plan id.

questionIdquestionTypeIdformIdAnnotated CRF NotePlan_1Plan_2
initialsinitialsregistrationNoRequired

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23676: Compiler check for required SDV questions

uDesign Feature Enhancement
Add compiler check to make sure the plan header listed in the form type and Question Type tab matches the plan defined in the plan sheet.

23677: Configure Signature plan

uDesign Feature Enhancement
The partial Signature plan should be defined in the newly added ‘Plan’ worksheet of the Data Architect file and configuration should be done in the Question Layout – Template worksheet of the Data Architect.

The plan configuration should include plan type, plan id, plan name, plan description, expression (expression is used to identify which plan the patient will be using).

Trial Design – Plans
Basic plan configurations can be completed on the new Plans worksheet.

Plan IdTypeNameDescriptionExpression
1SignatureSignature Plan 1Signature plan for site 1[toolID] == 15601
2SignatureSignature Plan 2Signature plan for site 2[toolID] == 15602

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23679: Select Questions that Do Not Require Signature

uDesign Feature Enhancement
Select the Questions that do not need to be Signed for each plan in the Question Layout tab.

Trial Design – Question Layout
After configuring a Signature plan, questions that should not require a signature can be marked with ‘No’ by creating a new row called “Plan_” followed by the plan id.

questionIdquestionTypeIdformIdAnnotated CRF NotePlan_1Plan_2
initialsinitialsregistrationNoRequired

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23680: Compiler check for required signature questions

uDesign Feature Enhancement
Add compiler check to make sure the plan header listed in the Question Layout tab matches the plan defined in the plan sheet.

23681: Configure Data Review plan

uDesign Feature Enhancement
The partial Data Review plan should be defined in the newly added ‘Plan’ worksheet of the Data Architect file and configuration should be done in the Question Layout – Template worksheet of the Data Architect.

The plan configuration should include plan type, plan id, plan name, plan description, expression (expression is used to idendity which plan the patient will be using).

Trial Design – Plans
Basic plan configurations can be completed on the new Plans worksheet.

Plan IdTypeNameDescriptionExpression
1Data ReviewData Review Plan 1Data Review plan for site 1[toolID] == 15601
2Data ReviewData Review Plan 2Data Review plan for site 2[toolID] == 15602

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23683: Select Questions that Do Not Require Data Review

uDesign Feature Enhancement
Select the Questions that do not need to be Reviewed for each plan in the Question Layout tab.

Trial Design – Question Layout
After configuring a Data Review plan, questions can be marked as not requiring Data Review by entering ‘No’ in a new row called “Plan_” followed by the plan id.

questionIdquestionTypeIdformIdAnnotated CRF NotePlan_1Plan_2
initialsinitialsregistrationNoRequired

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23684: Compiler check for required review questions

uDesign Feature Enhancement
Add compiler check to make sure the plan header listed in the Question Template tab matches the plan defined in the plan sheet.

23685: Creation of Dynamic Selection Plan

uDesign Feature Enhancement
Dynamic selection plans should allow for the definition of multiple plans, with multiple tiers of expressions that allow selection of the base percentage. The base percentage represents the percent chance that the form will be selected for SDV.

Trial Design – Plans
Basic plan configurations can be completed on the new Plans worksheet.

Plan IdTypeNameDescriptionExpression
1SDVSDV Plan 1SDV plan for site 1[toolID] == 15601
Dyamic PercentageDynaimc Expression
90{CALLSCRIPT=getCustomScore} < 90
10{CALLSCRIPT=getCustomScore} < 10
Plan IdTypeNameDescriptionExpression
2SDVSDV Plan 2SDV plan for site 2[toolID] == 15602
Dyamic PercentageDynaimc Expression
90#registration.dynamicGroup == ’1′
60#registration.dynamicGroup == ’2′
30#registration.dynamicGroup == ’3′

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

23686: Expression evaluation

uDesign Feature Correction
Expressions for tiers will be evaluated in order of configuration until an expression resolves as true.
If no expression matches, the chance becomes 100%.

Further comments:
The compiler makes sure the dynamic tiers are ordered in XML as defined in the Data Architect.

24224: Compiler should show error if Optional is used for nonSDV plan

uDesign Feature Enhancement
Add a compiler check for “Optional” value added to nonSDV plan.

24294: N/A status should propagate to record level

uEDC Feature Enhancement
If all forms don’t participate then the record will not participate.

24295: Questions or forms not participating in plans should not change the status

uEDC Feature Enhancement
If a form or question doesn’t participate in an SDV, Signature or Data Review plan, they shouldn’t be set as SDVed, Signed or Data Reviewed.

24308: N/A option should be added to filters if trial is set for partial metadata plan

uEDC Feature Enhancement
For Partial Metadata plans, N/A option should be added to “Signed Status”,”Data Review Status”,”Source Doc Verified” filters in Records,Forms,Questions managers.

24732: Move plan settings from form to question tab

uDesign Feature Correction
All plan setting should be done in one place on question template tab.
This requirement was created to reduce complexity and confusion of the current implementation when form and question level plans are combined for the partial metadata configuration.

25244: User Quality Score should only represent activity on production sites

uEDC Feature Enhancement
User Quality Score, Data Points Entered,Data Points Entered and SDVd,Data Points Changed for Query counts should be counted only for production servers for production sites.

25556: Metadata plan column should be added to record manager

Clinical ERP Feature Correction
Add metadata plan column to indicated the current plan for records.

23659 – Add Data Review Status

23659: Add Data Review Status

uEDC Feature Enhancement
Implement a new Data Review status to track the review of data within the uEDC product.
The statuses included should be ‘Not Reviewed’ (default status) and Reviewed. The status can be applied at a question and a form level. The status should roll up. For example, when all required questions on a form are marked Reviewed, the form is considered Reviewed. When all required subforms are marked Reviewed, the parent form will be considered Reviewed. If data on a Reviewed question is changed, the Reviewed status is reverted to Not Reviewed.

Trial Design – Roles Worksheet

ActionsActions RequiredScreens Required
metadata – data reviewdataReview, updateMetaData

For more information, see the Roles page for the Classic and Unified interface.

Trial Design – App Properties – Existing Studies
For studies existing at the time of the DBP 13.0.0 release, this feature will be turned off by default with the hideDataReviewStatus property. To make this status visible in existing studies, the hideDataReviewStatus property must be set to ‘false’ on the App Properties worksheet.

NameValue
hideDataReviewStatusfalse

For more information, see the Roles page for the Classic and Unified interface and the App Properties page.

24136: Add Data Review boxes to tabular view

uEDC Feature Enhancement
“Data Review All” and “Data Review” boxes should be added to tabular and zoom view.

24137: Email notification should support Data Review Status

uEDC Feature Enhancement
Add email notification for Data Review Status change.

24149: Add Data Review Status to export of manager

uEDC Feature Enhancement
Data Review Status column should be added to record manager export.

24150: Formatter Parameters should support data review status

uDesign Feature Enhancement
Export Formatter Parameters should support data review status.
- Add exportDataReview parameter.
- exportMetadata parameter should support export of Data Review Status.

Trial Design – Exports
Can be applied to all types of exports.
Formatter Parameter Name: exportDataReview
Formatter Parameter Value: true or false (false by default)

Param NameParam Value
exportDataReviewtrue

For more information, see the Exports page for the Classic and Unified interface

24153: Data review status should be supported in custom export

uEDC Feature Enhancement
Add an instruction to ExtendableExportFormatter to retrieve the data review status of the current form

Trial Design – Exports
Instruction Name: formDataReview

formTypeIdQuesiton IdInstructionValueColumn NumberColumn TitleData Type
formDataReview12DATA REVIEW STATUSString

See the DTLC page on Data Review Custom Exports in the Classic and Unified interfaces for more information.

24154: form statistics support for data review status

uEDC Feature Enhancement
Add data review status to Form Statistics and Data Point Report reports.

24155: Trial Summary should support data review status

uEDC Feature Enhancement
Add data review support to Trial Summary report

24156: Averages Report should support data review status

uEDC Feature Enhancement
Add data review support to Averages Report

24158: Subject Management should support data review status

uEDC Feature Enhancement
Add data review support to Subject Management report

24159: Custom Check List should support data review status

uDesign Feature Enhancement
Add data review support to Custom Check List report

Trial Design – App Properties
Note: this configuration is only needed in the Classic UI. Checklists in the Unified UI are saved through the Managers.

Checklist Name: DataReviewFilter
Possible Values: notReviewed, reviewed

NameValue
checklist1TitleSubject Manager – Data Review Status
checklist1RolesMonitor
checklist1ManagerrecordManager
checklist1DataReviewFilternotReviewed

See the DTLC page on Checklists in the Classic interface for more information. If using the Unified interface, see the new Checklist widget.

24161: uCTMS Subject Summary report should support data review status

uCTMS Feature Enhancement
Add support for Data Review Status to uCTMS Subject Summary report.

24162: Update Form Flow to account for Data Review Status

uEDC Feature Enhancement
Form Flow process should be updated to work properly with the introduction of new Data Review status.

24204: remove unnecessary plan tags

uDesign Feature Correction
If plan is not specified for form or question the xml shouldn’t generate blank plan tags.

24258: new actions should be added to Data Architect template

uDesign Feature Enhancement
Add following actions to Data Architect template:

dataReview,updateMetaData
requireSDV
changeMetaDataPlans
reconcileMetaDataPlans

24261: Add Data Review option to Audit filters

uEDC Feature Enhancement
“Audit Type” filter should have “Data Review” option.

24540: add translation key to DataReviewedForms label

uEDC Feature Correction
In the Trial Summary create a key for Data Reviewed forms.
Add translation key.

24470 – User Interface Redesign

23233: Create Servlet and Object Files To Support Dual Interfaces

System Feature Enhancement
Create a new servlet, JSP object file structure and locator to support the use of a newly added user interface. The existing DC servlet and JSP file structure and locator will continue to be used to support the existing user interface.

Trial Design – App Properties
Name: ui2012
Value: true or false (true by default for trials created after the 13.0 release, false by default for existing trials)

When the ui2012 property is set to true, the trial will be displayed in the Unified user interface for all users who have completed training for the Unified user interface.

Additional Note: When converting a study to the Unified interface, only users who have completed the user interface training will be able to access the study. Those who have not completed the training will be unable to access the study until they complete the training.
NameValue
ui2012true

For more information, see the new section on this property for the Classic and Unified interfaces.

23405: Create Stylesheet To Support User Interface Redesign

System Feature Enhancement
Create a general style sheet to support the rewrite of the DATATRAK One user interface. The style sheet should provide an modernized look and feel and should be applicable to all products.

23733: Private Labeling Products

Clinical ERP Feature Enhancement
Support the ability to replace the DATATRAK logo with a customer’s logo.

24494: DataCollector/medicalResearch UI Updates

uEDC Feature Enhancement
Update all DataCollector/medicalResearch files with the ui2012 style.

24712: Style Workflow JSPs

Clinical ERP Feature Enhancement
Update all Workflow JSPs in the ui2012 style.

24713: Style LMS JSPs

uTrain Feature Enhancement
All LMS JSPs need to be updated with the ui2012 style.

uCTMS Feature Enhancement
The header and footer should be replaced on all reports so that it is consistent with the 2012 user interface redesign.

24773: Allow Role Selection in Form Base View

uEDC Feature Enhancement
The new UI combines all role permissions by default, giving you access to all actions that you have across all roles.

There is a profile question called ‘Allow Role Selection’. If this is checked, there should be a new menu that appears next to the user’s name in the header. So between the name and the help link or between the name and the study/site listing. It should act like the other menus where hovering or clicking it should expand/show the menu. The current role should be shown in the menu and all other roles would be in the menu itself.

25247: Style Billing Tool

Clinical ERP Feature Enhancement
Style all elements of the billing tool to match the new UI.

25452: Do not check for HR in the group display title for the new UI

uEDC Feature Correction
The new UI does not need HR html elements in the group title to look well. Indeed the HRs should not be used anymore.

Trial Design – App Properties

Property Name: useLegacyHR
Possible Values: true or false (false by default)

NameValue
useLegacyHRfalse

For more information, see the App Properties page for the Unified interface.

25515: Update Style Elements of the Imports Manager Screen

uEDC Feature Enhancement
Update Style Elements of the Imports Manager screen to be consistent with the 2012 user interface.

25516: Update Style Elements of the Exports Manager Screen

uEDC Feature Enhancement
Update Style Elements of the Exports Manager screen to be consistent with the 2012 user interface.

26249: The Change Enrollment action should be supported in the new UI

uEDC Feature Enhancement
The Change Enrollment action should be supported in the new UI and all related screens updated for the new UI.

27004: Create method for Course Completion to set User Property

uTrain Feature Enhancement
Users will be required to complete an eLearning course on the new UI desktop and collaboration tools prior to switching their user property to UI2012.

Create a method for automating the user property switch as the result of a completed course pre-requisite.

27005: Method for restricting prerequisites based on User property setting

uTrain Feature Enhancement
The course intended for transitioning users from the classic interface to the new UI desktop and collaboration tools should only be applicable to users with the UI2012 property set to false.

28196: Chinese translation keys

System Feature Enhancement
Keys throughout the DBP production need to be translated to Chinese.

28529: Alert manager – Add column “Open Queries”, remove hybrid columns

uEDC Feature Enhancement
Add a column “Open Query Count” to the Alert Manager which can be filtered and sorted.

Remove the hybrid columns:
- Question (Open Queries) and Value
- Question and Form

With the new column added, all information will be available in other columns.

29077: The user should be able to switch between UI versions through the Profile page.

uEDC Feature Enhancement
When a user views the Profile page, there should be an ‘Interface’ option with a menu for selecting a particular UI. This menu will have two options, ‘Classic’ and ‘Unified’, with Unified being the new interface designed for the 13.0 release.

24687 – Update System Managers

24165: UI Update for Queries Manager

uEDC Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24166: UI Update for Alerts Manager

uEDC Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24167: UI Update for Forms Manager

uEDC Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24168: UI Update for Questions Manager

uEDC Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24169: UI Update for Coding Manager

uEDC Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24170: UI Update for Synonym Manager

uEDC Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24171: UI Update for Audits Manager

uEDC Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24172: UI Update for Comments Manager

uEDC Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24174: UI Update for Subject Manager

uEDC Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24179: Manager columns should be able to be shown or hidden

uEDC Feature Enhancement
Columns in the manager should be able to be shown/hidden on an individual basis. This preference should be automatically remembered for a user.

24180: Manager columns should be filterable

uEDC Feature Enhancement
Filters in the manager should be removed from the top section, and added to the column headers. Each filter that exists today without a matching column should be added as a column in order to maintain existing functionality.

24181: Manager data should be sortable

uEDC Feature Enhancement
Data within the manager should be sortable at multiple levels. Clicking on a column will cause the data to be sorted by that column. The last clicked column should become the primary sort. Clicking a column again should flip the sort order between ascending and descending.

24691: Create Visit Manager

uEDC Feature Enhancement
Create Visit Manager that is consistent with look, filters, sorting capability to meet the requirements for the 2012 UI initiative

24692: UI Update for Drug Assignment Manager

uIRT Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative

24694: UI Update for Drug Container Manager

uIRT Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative

24695: UI Update for Schedule Manager

uIRT Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24696: UI Update for Shipment Manager

uIRT Feature Enhancement
Update look, filters, sorting capability to meet the requirements for the 2012 UI initiative.

24699: Create Managers JSP

uEDC Feature Enhancement
Create a JSP for use in the 2012 User Interface managers. The JSP should be consistent with the style elements of the 2012 UI and support that java functionality defined for the managers. The following metadata statuses will have progress bars to reflect the status: Answer, Alert, Data Review, Freeze, Lock, Query, Sign and SDV. When the user hovers the mouse over the progress bar, they should receive additional information about the status. The Query and Alert progress bars should indicate how many questions are open and closed for a form. The other progress should indicate the number of questions without the status, with the status and in need of the status.

26129: The form save process should use ajax technology

uEDC Feature Enhancement
Change the form save process to use Ajax technology.

26251: Properties should be added to support the designation of a metadata status workflow

uDesign Feature Enhancement
A set of properties should be added to the App Properties worksheet so that a metadata status workflow can be defined. These properties will designate the proper order for the following metadata statuses: Complete, Data Review, SDV, Freeze, Lock and Sign. These properties will affect the progress bars in the managers and will not have default values.

The compiler check for each property should read:
Error: needsSign should be configured in App Properties. Possible values are: InProgress, Completed, Reviewed, Frozen, Verified, or None.
Error: needsFreeze should be configured in App Properties. Possible values are: InProgress, Completed, Reviewed, Verified, Signed, or None.
Error: needsLock should be configured in App Properties. Possible values are: InProgress, Completed, Reviewed, Frozen, Verified, Signed, or None.
Error: needsSDV should be configured in App Properties. Possible values are: InProgress, Completed, Reviewed, Frozen, Signed or None.
Error: needsDataReview should be configured in App Properties. Possible values are: InProgress, Completed, Frozen, Verified, Signed or None.

Trial Design – App Properties
Five properties can be set to designate the metadata status workflow. Each property name accepts one value. As a form or question reaches the status designated in the Value column, it will need the status designed in the corresponding Name column. The value, none, can be used to designate that no status is required.

Property Names: needsDataReview, needsSDV, needsFreeze, needsSign, needsLock
Acceptable Values: inProgress, completed, reviewed, verified, frozen, signed, none

The following configuration will create the metadata status workflow: Forms Completed > Data Review > SDV > Freeze > Sign > Lock.

NameValue
needsDataReviewcompleted
needsSDVreviewed
needsFreezeverified
needsSignfrozen
needsLocksigned

For more information, see the Needs property section of the App Properites page for the Unified interface.

26592: Not Applicable message needed for partial sdv in new UI

uEDC Feature Correction
The managers should display a “Not Applicable” message over the white status bar when the form is not included in a plan.

26637: Site filter should be added to Visits manager

uEDC Feature Enhancement
The site filter should be included in the Visits Manager.

26729: Managers should show site filter if only one site exists

uEDC Feature Correction
To be consistent with the other restricted choice columns and to be clearest to the end user, the tool name filter should not prevent the filter options from being populated if only one tool exists in the current application.

27444: Manager Filter Label Adjustments

uEDC Feature Enhancement
The filter labels in the Managers should be changed as follows:
- SDV should have: No Verification Needed, Verification Needed, Not Verified, Partially Verified, Verified
- Data Review: No Review Needed, Review Needed, Not Reviewed, Partially Reviewed, Reviewed
- Freeze: No Freeze Needed, Freeze Needed, Not Frozen, Partially Frozen, Frozen
- Lock: No Lock Needed, Lock Needed, Not Locked, Partially Locked, Locked
- Sign: No Signature Needed, Signature Needed, Not Signed, Partially Signed, Signed
- Alert: Open Alert, Clean
- Query: Open Query, Clean

uEDC Feature Enhancement
Subject Manager:
-Answer Status, Frozen Status, Lock Status, SDV Status, Data Review Status, Signature Status should be directed to Form Manager with existing filters and filters derived from progress bar section clicked
-Alert Status should be directed to Alert Manager with existing filters and filters derived from progress bar section clicked
-Query Status should be directed to Query Manager with existing filters and filters derived from progress bar section clicked

Form Manager:
-Answer Status, Frozen Status, Lock Status, SDV Status, Data Review Status, Signature Status should be directed to Question Manager with existing filters and filters derived from progress bar section clicked
-Alert Status should be directed to Alert Manager with existing filters and filters derived from progress bar section clicked
-Query Status should be directed to Query Manager with existing filters and filters derived from progress bar section clicked

27934: No visibility to saved search without checklists widget

uEDC Feature Enhancement
If you create a saved search and do not have the checklist widget turned on or do not know that this is where the saved search will be found, it can be very confusing to the user in regards to how to access these saved searches.
To alleviate this, we should create a confirmation within the manager that appears when a saved search is created.

If the checklist widget is not currently set to display on the study homepage when the user saves a search, the system displays the following message: “The Saved Search X has been created. You will need to enable the ‘My Checklists’ widget on the Study Home Page to access these saved searches.”
If the checklist widget is currently set to display on the study homepage when the user saves a search, the system displays the following message: “The Saved Search X has been created and will be found on the Study Home Page in the ‘My Checklists’ widget.”

24739 – Collaboration Tools

23605: Style File Manager

Clinical ERP Feature Enhancement
Update styling on the filters, data listing, icons, and general layout of the File Manager. The file types should be indicated by specific file type icons. The tree will be replaced by a newer Javascript tree, probably a Jquery tree

23646: Style Calendar Layouts

Clinical ERP Feature Enhancement
Update the styling of the calendar, providing a better layout with cleaner organization and better navigation options including the basics for allowing the overlay of multiple calendars.

23702: All in One file Manager

Clinical ERP Feature Enhancement
Merge user file manager and workgroup file manager.

23703: Update File Manager View

Clinical ERP Feature Enhancement
Update File Manager view to focus on folder style viewing. Folder stucture should include personal folders, studies and workgroups.

23705: Create, Delete & Nest Folders

Clinical ERP Feature Enhancement
Support creation, deletion and nesting folders.

23706: Search For Study

Clinical ERP Feature Enhancement
Support the ability to search for a study.

23708: Update Calendar

Clinical ERP Feature Enhancement
Update the Calendar to be more versatile & user friendly.

23709: Print Calendar

Clinical ERP Feature Enhancement
Support the ability to print a user’s calendar.

23710: Add Date Picker

Clinical ERP Feature Enhancement
Implement a date picker.

23712: Provide different views

Clinical ERP Feature Enhancement
Provide different views like in outlook

23714: Add a Calendar Filter

Clinical ERP Feature Enhancement
Support the ability to filter the data/events displayed on a user’s calendar.

23715: Expand the Information Displayed

Clinical ERP Feature Enhancement
Expand the information displayed on a user’s calendar to include study level info such as subject visit dates, drug expiration dates, expected delivery date, etc.

23760: Study Homepage flag for Documents

Clinical ERP Feature Enhancement
Provide a flag on the document creation/modification screens to allow including a file from a study workgroup on the study homepage.

23798: All in One Contact Manager

Clinical ERP Feature Enhancement
Merge user contact manager and workgroup contact manager.

23799: All in One Calendar

Clinical ERP Feature Enhancement
Merge user calendar and workgroup calendar.

23800: Combine calendar and task tools

Clinical ERP Feature Enhancement
Merge calendar and task

24473: Style Contacts Manager

Clinical ERP Feature Enhancement
Update all style elements of the Contacts Manager

25382: File Manager: change the name of ‘Folder’ to ‘Move to’

Clinical ERP Feature Correction
The name ‘Folder’ should be changed to ‘Move to’.

25398: Memory information for workgroups should be listed in separate columns

Clinical ERP Feature Correction
Workgroups listed along with folders display what appears to be maximum space and available space in the edit and delete columns. This data should be clarified by either creating new columns or placing it into tool tips instead of the existing columns.

25401: Add tooltips for edit and delete icons that explain why a file cannot be edited or deleted

Clinical ERP Feature Enhancement
Add a tooltip for edit and delete icons that explains why a file cannot be edited or deleted (i.e. You do not have permission to edit this file)

25405: File Manager: Search should be cleared if user navigates away from the current page using the tree

Clinical ERP Feature Correction
Search should be cleared if user navigates away from the current page using the tree

25478: Calendar: style buttons and update date picker

Clinical ERP Feature Enhancement
Buttons should be styled with new UI and datepicker should be updated too.

26414: Remove Workflow Process from the task

Clinical ERP Feature Enhancement
Workflow Process should be removed from the Task.

24743 – Data Genie

24245: Update Style Elements of the Data Genie ‘Reports Manager’ Main Screen

uEDC Feature Enhancement
Implement new style elements within the main screen of the Report Manager.

24246: Update Style Elements of the Create Report Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Create Report Screen.

24247: Update Style Elements of the Field Selection Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Field Selection Screen.

24248: Update Style Elements of the Add/Edit Aggregator Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Add/Edit Aggregator Screen.

24249: Update Style Elements of the Aggregate If Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Aggregate If Screen.

24250: Update Style Elements of the Filters, Sorts & Parameters Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Filters, Sorts & Parameters Screen.

24251: Update Style Elements of the Create Filter Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Create Filter Screen.

24252: Update Style Elements of the Create Sort Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Create Sort Screen.

24253: Update Style Elements of the Create Parameter Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Create Parameter Screen.

24254: Update Style Elements of the Edit Output Settings Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Edit Output Settings Screen.

24255: Update Style Elements of the Permissions Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Permissions Screen.

24256: Update Style Elements of the Edit Report Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Edit Report Screen.

24257: Update Style Elements of the Delete Report Screen

uEDC Feature Enhancement
Implement new style elements within the Report Manager’s Delete Report Screen.

uEDC Feature Enhancement
When a user chooses to lock a report while Role Selection is disabled, the system will prompt the user to specify which role can unlock the report.

26705: Show question text in field creation screen

uEDC Feature Enhancement
In DataGenie, the tree should show the question text for each field instead of the variable name. Due to some question text being very long, the value should be cutoff between 20 and 30 characters with ‘…’ added to the visible text to indicate that it is trimmed. If the user hovers over the question text, it should show the full question text as well as the question variable.

26707: Enhance the browser report screen

uEDC Feature Enhancement
The browser output in DataGenie should include the ability to use sorting, filtering, paging, and give the user multiple output types for the data presented.

24746 – Randomization Manager

24236: Update Populate Strata Screens

uIRT Feature Enhancement
Update the screens associated with the ‘Populate Strata’ feature included in Randomization Manager 3.0

24237: Update Import Strata Screens

uIRT Feature Enhancement
Update the screens associated with the ‘Import Strata’ feature included in Randomization Manager 3.0

24238: Update Import Inventory Screens

uIRT Feature Enhancement
Update the screens associated with the ‘Import Inventory’ feature included in Randomization Manager 3.0

24239: Update Initiate Shipment Screens

uIRT Feature Enhancement
Update the screens associated with the ‘Initiate Shipment’ feature included in Randomization Manager 3.0

24240: Update Treatment Distribution Screens

uIRT Feature Enhancement
Update the screens associated with the ‘Treatment Distribution’ feature included in Randomization Manager 3.0

24241: Update Treatment/Stratum Distribution Screens

uIRT Feature Enhancement
Update the screens associated with the ‘Treatment/Stratum Distribution’ feature included in Randomization Manager 3.0

24242: Update Treatment/Factor Level Distribution Screens

uIRT Feature Enhancement
Update the screens associated with the ‘Treatment/Factor Level Distribution’ feature included in Randomization Manager 3.0

24243: Update Export Randomization Schedule CSV Screens

uIRT Feature Enhancement
Update the screens associated with the ‘Export Randomization Schedule CSV’ feature included in Randomization Manager 3.0

24244: Update Export Randomization Schedule Excel Screens

uIRT Feature Enhancement
Update the screens associated with the ‘Export Randomization Schedule Excel’ feature included in Randomization Manager 3.0

24492: Update Create Slot screens

uIRT Feature Enhancement
Update the screens associated with the ‘Create Slot’ feature included in Randomization Manager 3.0

24493: Update Populate Inventory screens

uIRT Feature Enhancement
Update the screens associated with the Populate Inventory feature included in Randomization Manager 3.0

24711: Style Miscellaneous Randomization Manager 3 pages

uIRT Feature Enhancement
RM 3 pages are in need of new styling

25739: Randomization actions should be grouped together under Actions tab

uIRT Feature Correction
All the randomization actions should be grouped together under the Randomization header in the Actions tab.

24748 – Homepage Widgets

23610: Widget – Announcements

uEDC Feature Enhancement
An announcement widget must be available and not removable. It should use a yellow container div to hold the information to make it stand out.

23611: Widget – Record Status

uEDC Feature Enhancement
The content of this widget will be controlled by the properties of the study in regards to UI layout for the Subject Status feature. This widget should appear under the announcements.
The requirements are changed as follows:
1) There will be 4 columns:
a) Status (status name)
b) Current (count of subjects that currently have this status)
c) Total (historical count of subjects that have had this status)
d) Change (difference between user’s last login and one of the items defined below as a widget preference)
Widget Preference called ‘Change Period’ with the options:
Since last login (default), Last x days (need additional input for x), Past week
The widget also must have a button for enrolling new patients and a total number of records listed.

23612: Widget – Study Documents

uEDC Feature Enhancement
This widget should show all documents posted to it by the study file manager admins. They should be able to designate in the study file manager which documents should appear in this list.

23613: Widget – Ad-hoc Reports

uEDC Feature Enhancement
These widgets should allow the user to choose any reports that have been set as able to be viewed on the study homepage. If the report has not specifically been designated as viewable on the study homepage it should not be an option for selection.

23614: Widget – Checklists

uEDC Feature Enhancement
A checklists widget will include any custom checklists defined by the sponsor in the configuration as well as any standard checklist items but we should also allow the users to configure the checklists to include all applicable checklist type items.
Added Requirements: The checklist widget should include saved-search parameters from the managers as specified by the user. The user can attach a meaningful name to this search which should be included in this widget’s display.

23615: Widget – Recently Modified Subjects

uEDC Feature Enhancement
This widget should provide a listing of the last 5 records that the user accessed. It should list the record name, site, when they were enrolled, and if they are randomized if randomization is turned on and subject status is configured.

23616: Widget – Shipment Confirmations

uEDC Feature Enhancement
A widget should be created that can support the viewing and confirmation of investigational product.

23617: Widget – Questions Most Queried

uEDC Feature Enhancement
A widget should be created that displays the questions most queried data similar to the trial summary report.

23618: Widget – Questions Most Alerted

uEDC Feature Enhancement
A widget should be created that displays the questions most alerted data similar to the trial summary report.

23619: Widget – Medical Coding

uEDC Feature Enhancement
A widget should be created that displays coding information. This should include the number of uncoded/partially coded/coded terms. It should also display the dictionaries that are being used in the system.

23621: Widget – Averages Report

uEDC Feature Enhancement
A widget should be created that allows the user to select various numbers from the Averages Report.

23622: Widget – Calendar

uEDC Feature Enhancement
A widget should be created that allows the user to show their calendar with the current study overlayed on top of it.

23637: Exportable Widget Data

uEDC Feature Enhancement
All widgets that provide data or status information should be exportable, preferably in Excel format.

24182: Widget Framework

uEDC Feature Enhancement
Implement an overall framework to manage different widget objects. Each widget should have some basic configurations: position/location, limits to returned items if applicable, default role access, removable/not removable, general access to settings. The contents of each widget should also be exportable by some standard means. The widgets should also load after other elements on the page which could be done with either AJAX or some other data structure that is not dependent on other portions of the page.

26582: Sharing option for checklists should be configured on widget Configuration page

uEDC Feature Enhancement
For the Checklist widget, admins of the primary study workgroup should see a permission window on the Widgets configuration page where they can select what roles have permission to share checklists. Admins should be able to change these permissions at any time. When set, those with permission to share will see the share option on the widget while those without permission will not.

27015: Notifications needed on Widgets configuration page when configuring widget layout

uEDC Feature Enhancement
The user should be informed when a widget cannot be hidden. Additionally, each time a widget is moved within the Widget Layout table, the message that the homepage was updated should display.

24749 – Enterprise Manager

23290: Create Contributor Role For Workgroups

Clinical ERP Feature Enhancement
Support adding a Contributor role to a workgroup. The Contributor will have the ability to add, delete and manage.

24175: Update menu UI throughout Enterprise Manager

Clinical ERP Feature Enhancement
All action bar functionality should be updated to be more user friendly and specifically context based.

24176: Reduce pop-up functionality

Clinical ERP Feature Enhancement
Where possible, use Javascript/Modal/Slide-out windows instead of existing pop-up window functionality for navigating through various actions. Other options include more on-screen wizard based functionality. The user must remain at the correct place in the tree structure at all times regardless of the chosen option.

24177: General Update to UI to mirror 2012 look

Clinical ERP Feature Enhancement
All screens should use the new header/footer and general ui2012 styling that is being implemented in the rest of the system. The pages should look modern, use reasonable padding, updated icons, and have more polished look and feel.

24178: Replace Tree in Enterprise Manager

Clinical ERP Feature Enhancement
Update the tree in Enterprise Manager to use Dynatree with all associated context menus.

Clinical ERP Feature Enhancement
Style the jsps related to contributor roles.

27755: Unlock User tab should be displayed only in staging.datatrak.net

Clinical ERP Feature Correction
Unlock User tab should be displayed only in staging.datatrak.net server (secure.datatrak.net in production).

24750 – Trial Manager

24231: Update Style Elements of the Design Node in Trial Manager

Clinical ERP Feature Enhancement
Implement new style elements within all portions of the Design node within the Trial Manager.

24232: Update Style Elements of the Test Node in Trial Manager

Clinical ERP Feature Enhancement
Implement new style elements within all portions of the Test node within the Trial Manager.

24233: Update Style Elements of the Approve Node in Trial Manager

Clinical ERP Feature Enhancement
Implement new style elements within all portions of the Approve node within the Trial Manager.

24234: Update Style Elements of the Production Node in Trial Manager

Clinical ERP Feature Enhancement
Implement new style elements within all portions of the Production node within the Trial Manager.

24267: Remove Data Review Status column from Trial Manager

uDesign Feature Enhancement
Data Review Status column should be removed from Trial Manager.

25624: Create Sub Client feature should be supported in new UI

Clinical ERP Feature Enhancement
The Create Sub Client feature should be available in the styling of the new UI and be functional.

27478: When accessed, Trial Manager should start at the records manager

Clinical ERP Feature Correction
The Trial Manager homepage should be removed. Upon accessing Trial Manager, the user should be directed to the records manager. The green actions menu will also need to be customized to provide access to actions currently only accessible from the Trial Manager homepage.

28656: Add help text for the dynamic forms in Trial Manager

Clinical ERP Feature Enhancement
The “Add …” links in Trial Manager should use the core code feature to display help text with the link.

28657: Implement Trial Manager restriction handling with core code features

Clinical ERP Feature Enhancement
Remove the custom restriction handling for Trial Manager and use the new core code features to implement the old functionality.

28658: Restrict the adding and removal of forms in Trial Manager for the new UI

Clinical ERP Feature Enhancement
The insertion of forms in the Trial Manager should be restricted to specified roles and specific forms.

24751 – Standard Reports

23920: Update Styling of Trial Summary

uEDC Feature Enhancement
Update the styling of this report to reflect the changes in the UI and to make the report more readable.

23921: Update Styling of Form Statistics

uEDC Feature Enhancement
Update the styling of this report to reflect the changes in the UI and to make the report more readable.

23922: Update Styling of Alert Statistics

uEDC Feature Enhancement
Update the styling of this report to reflect the changes in the UI and to make the report more readable.

23923: Update Styling of Query Statistics

uEDC Feature Enhancement
Update the styling of this report to reflect the changes in the UI and to make the report more readable.

23924: Update Styling of Data Point Report

uEDC Feature Enhancement
Update the styling of this report to reflect the changes in the UI and to make the report more readable.

23925: Update Styling of Subject Statistics

uEDC Feature Enhancement
Update the styling of this report to reflect the changes in the UI and to make the report more readable.

23926: Update Styling of Averages Report

uEDC Feature Enhancement
Update the styling of this report to reflect the changes in the UI and to make the report more readable.

23927: Update Styling of Visit Schedule

uEDC Feature Enhancement
Update the styling of this report to reflect the changes in the UI and to make the report more readable.

23928: Update Styling of Patient Management Report

uEDC Feature Enhancement
Update the styling of this report to reflect the changes in the UI and to make the report more readable.

24752 – Mid Study Utilities

24355: Update Style Elements of the Create Query Screen

uEDC Feature Enhancement
Implement new style elements within the Create Query screen.

24356: Update Style Elements of the View Query Screen

uEDC Feature Enhancement
Implement new style elements within the View Query screen.

24357: Update Style Elements of the Create Comment Screen

uEDC Feature Enhancement
Implement new style elements within the Create Comment Screen.

24405: Update Style Elements of the Reconcile Record Screen

uEDC Feature Enhancement
Implement new style elements within the Reconcile Record Screen.

24406: Update Style Elements of the Move Record Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Move Record utility Screen.

24407: Update Style Elements of the Move Form Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Move Form utility Screen.

24408: Update Style Elements of the Update Form Configuration Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Update Form Configuration utility Screen.

24409: Update Style Elements of the Insert Form Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Insert Form utility Screen.

24410: Update Style Elements of the Refresh MetaData Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Refresh MetaData utility Screen.

24411: Update Style Elements of the Rename Form Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Rename Form utility Screen.

24412: Update Style Elements of the Update Names Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Update Names utility Screen.

24413: Update Style Elements of the Update Sequence Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Update Sequence utility Screen.

24414: Update Style Elements of the Update Question Type Utility Screens

uEDC Feature Enhancement
Implement new style elements within the Update Question Type utility Screens.

24415: Update Style Elements of the Reconcile Form Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Reconcile Form utility Screen.

24416: Update Style Elements of the Coding Dictionary Upgrade Utility Screens

uEDC Feature Enhancement
Implement new style elements within the Coding Dictionary Upgrade utility Screens.

24417: Update Style Elements of the Dynamic Status Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Dynamic Status utility Screen.

24418: Update Style Elements of the Update Questions Utility Screen

uEDC Feature Enhancement
Implement new style elements within the Update Questions utility Screen.

26138: Support reconcile Metadata Counts utility

uEDC Feature Enhancement
A mid study change utility should be implemented that is responsible for reconciling the metadata counts for existing records and the definition of the “Needs” properties configured in the DA. This means that if the metadata status workflow that the trial uses is changed, this reconcile feature can be used to update the progress bars in the Managers. The reconcileMetaDataCounts permission should also be added to the Data Architect template.

Trial Design – Roles

ActionsActions RequiredScreens Required
Reconcile Metadata CountsreconcileMetaDataCounts

For more information, see the new DTLC page on Partial Metadata for the Classic and Unified interfaces.

uEDC Feature Enhancement
After ‘Reconcile’ or ‘Reconcile (Process Assignments)’ is selected, their links should be replaced with plain text labels that contain the process name and the message, “Running.” After the process is complete, the links should be displayed again and include a message that indicates if the process was successful or not.

24766 – UI Style

23407: Style New Header

uEDC Feature Enhancement
Create a framework to support the rewrite of the user desktop and collaboration tools.

23606: Style New Header

uEDC Feature Enhancement
Update styling of header area of general platform.

23607: Style Login Page

uEDC Feature Enhancement
The login page will be reworked to be more vertical. It should have a simple area for the actual login and language modification and the rest should be focused on branding, system messages, news items, announcements, etc.

23608: Style New Desktop

uEDC Feature Enhancement
The tree on the left will be changed to a generic list of applications.

23609: Style New Study Homepage

uEDC Feature Enhancement
The new study homepage will no longer have the current layout with home and homeRight.jsp. There should be a single JSP broken down into 2 columns.

23732: Style New Profile Layout

uEDC Feature Enhancement
The profile page needs to be updated to the new layout and simplified structure where possible. Old functionality (fax, internal email, etc.) should be reviewed for need of continued use and movement to the new UI.

24463: Style all Exceptions

uEDC Feature Enhancement
All exceptions need to be updated to reflect the new style.

24485: Style Properties Files (TaskPropertiesServlet)

Style the necessary pages under the TaskPropertiesServlet that are still used in the Files/Contacts Manager.

uEDC Feature Enhancement
Change the footer so that it reads “DATATRAK” rather than “DATATRAK International.”

24767 – Tabular Display

23631: Modified access to Tabular Entry

uEDC Feature Enhancement
A new icon will be placed to the left of the form name that will allow the user to view the current form or set of forms in tabular entry view. If the current form is setup using tab groups or some other tabular configuration, the user should be able to switch back and forth between the tabular and list view from this same location.

24769 – Standardize Visits

22736: Add Columns to Forms-Template tab

uDesign Feature Enhancement
Add five columns to Forms-Template titled ‘Visit Name’, ‘Expected Visit Date’, ‘Begin Window’, ‘End Window’, and ‘Actual Date.’ An example valid input for the two window inputs is ‘#day1.visitdt + 5|d’. The user will only fill these columns in on forms that they wish to designate as a visit. All child forms of that form will then be a part of that visit.

Trial Design – Forms-Template
Add five new columns called Visit Name, Actual Date, Expected Date, Begin Window, End Window. The Actual Date, Expected Date, Begin Window and End Window can all accept an offset and don’t necessarily need to be completed.

formIdformTypeIdForm NameParentAutoCreateVisit NameActual DateExpected DateBegin WindowEnd Window
c1d1visitDay 1cycle1trueDay 1 Visit#cycle1.c1d1.visitdt
c1d8visitDay 8cycle1trueDay 8 Visit#cycle1.c1d8.visitdt#cycle1.c1d1.visitdt + 7|d#cycle1.c1d1.visitdt + 3|d#cycle1.c1d1.visitdt + 10|d

See the new DTLC page on the Visit Manager in the Unified interface for more information.

22741: Add compiler checks for visit columns

uDesign Feature Enhancement
Add a warning if expected visit date equals another expected visit date. Error if invalid paths present (can be either relative or absolute).

22745: Create DCVisit

uDesign Feature Enhancement
Create a visit object that is a functionality wrapper around DCForm to support the export of visit data.

25562: Forms are not visits if they have a parent that is a visit

uDesign Feature Correction
A child form should be a visit if any of its parents are a visit.

25616: DCVisits should be linked via DCRecord

uDesign Feature Enhancement
A record’s visits should be directly accessible via the database instead of going through forms.

25626: Add visit to exports

uDesign Feature Enhancement
Add Visit column to DCFormFormatter associated with exports in a way that it only appears for configured trials.

25723: Add Visit Manager to Roles Tab

uDesign Feature Enhancement
Add visitManager to roles tab in template DA.

Trial Design – Roles

ActionsActions RequiredScreens Required
Visit ManagervisitManager

See the new DTLC page on the Visit Manager in the Unified interface for more information.

23763 – Implement a form base view

23623: Pinned Questions Bar – Configurable

uEDC Feature Enhancement
The ‘demographic bar’ needs to be modified. The study and site information should be removed. It is present in the header. The primary and secondary identifiers should still be present. Additionally, the user should have the option to go to any question in the casebook and indicate that that field should appear in the Pinned Questions bar. The user should be able to edit the contents of the Pinned Questions bar and this should be a user level setting that is retained. The Pinned Questions bar must also be collapsible so that if the user is not really using this information, it does not take up valuable data entry space.

See the DTLC page on Pinned Questions for additional information.

23624: Question Audits Location

uEDC Feature Enhancement
There should be an icon to the left of the question that when clicked will expand a box under the question showing all question audits. The retrieval of the question audits should be performed via ajax.

23625: Form Audits Location

uEDC Feature Enhancement
There should be an icon to the left of the form name that when clicked will expand an area to show all form level audits. The same filters and options should be available in this box that are also available in the current view. This information should be loaded via ajax.

23626: Auto RFC and Show Info Buttons

uEDC Feature Enhancement
These buttons should now appear on the left side of the subject bar as action buttons.

23627: Replace Tree in eCRF View

uEDC Feature Enhancement
The tree on the left of the casebook view will be replaced with a new Javascript tree. The tree must persist between page loads (cookie functionality), should be configurable in terms of design and skin and should include a filter if at all possible to filter the tree.

23628: Location Bar Modifiations

uEDC Feature Enhancement
The location bar (bread crumbs) will now only be visible when you are in the casebook. It will now only start at the subject level. The study/site information is not necessary. It will appear directly under the header (above the application menu).

23630: Date Field Calendar Replacement

uEDC Feature Enhancement
The date picker on date fields on the eCRF must be replaced with a Jquery calendar that is more user friendly and easier to configure and modify as changes happen. It should support a 2 month view (current and previous month) for easier data entry.

Trial Design – App Properties
By default the date picker covers a 10 year range back from the current date and 10 years ahead. 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 type ID of the question you are applying the range to. In the Value column two numbers should be entered in the following form “-13:+7″. These numbers are offsets from the current year that define the range covered by the picker. So in the year 2013, the above range would cover 2000 – 2020.

NameValue
yearRange-dobdt-31:-18

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.

See the date fields section of the App Properties page in the Unified interface for more information.

23632: Visit Name added to the form name

uEDC Feature Enhancement
In all instances, if the study has defined Visits, the visit of the current form will be prepended to the form name (ie. Visit 1 > Vital Signs).

23635: Dependent Questions

uEDC Feature Enhancement
The eCRF view should support dependent questions. If an question is only necessary when another question is answered a certain way, it should remain hidden until needed. However, there should be a way to force the hidden question to be opened at anytime and if the secondary question is answered it cannot be closed.

Trial Design – Question Types
Add a new column called “Visibility”
Possible values: A boolean expression that compares a questionTypeId’s data value. Only when the Boolean expression evaluates to true will the question be visible.

questionTypeIdQuestion TextData TypeDisplay TypeDate FormatAnswer Options / Default ValuelogChangelogAlertlogSkipInvalid Format AlertHelp TextField SizeVisibility
raceRace:StringRadioCheckboxW||White::A||Asian::AA||Black::OT||OtheryesRequiredyesOptionalno
raceothIf ‘Other’, please specify:StringTextyesRequiredyesOptionalnorace == ‘OT’

Additional Notes

  • Dependent Questions that have an answer, an alert or need an RFC will be visible regardless of their configuration
  • Be sure to check the title of the question when creating dependent questions. If the questions are numbered, the numbers may appear to skip if a numbered question is hidden
  • Alerts on dependent questions should be configured such that they do not fire when the question should be hidden

See the Visibility section of Question Types help page in the Unified interface for more information.

23644: Query Icon on eCRF

uEDC Feature Enhancement
We must have the ability to quickly generate queries from the screen which requires us to add an additional icon for Queries.

23645: Tree Must Open and Remember Properly

uEDC Feature Enhancement
The navigation tree must remember previous navigation steps as well as remember open locations properly.

23688: Change query resolution process

uEDC Feature Enhancement
The query resolution process shall (also) be embedded in the new form base view.

23689: Form base view shall asynchronously check dependencies, format alerts, script alerts, and assignments to the own form

uEDC Feature Enhancement
The form base view shall asynchronously check with the servers and update dependencies, format alerts and script alerts. The users shall be able to provide reasons for change and reasons for override without requiring to save the data first. The save button shall be disabled, when problems exist that are required to be resolved.

23690: Form base view shall save data on click of the save button

uEDC Feature Enhancement
Under normal circumstances the data shall be able to be saved without any redisplay of the form. A redisplay might be required due to multi-user activity or circular dependencies with other forms.

23691: Script handling for form base view

uEDC Feature Enhancement
It shall be possible to use script alerts that are firing before the “Save button” on the form is pressed. Care needs to be taken that no script commands are executed that modify the environment except alert commands.

Trial Design – Scripts
The “when” attribute must be set to “preprocess” when configuring alerts within a script. Otherwise an error will occur during compilation.

23692: Meta data handling for form base view

uEDC Feature Enhancement
The form base view shall asynchronously handle and store meta data. No final click on save shall be done. Icons shall be used instead of check boxes.

23693: Audits should be embedded in the form base view

uEDC Feature Enhancement
Audits should be displayed in the form base view without requiring a page refresh

24217: Info mode for form base view

uEDC Feature Enhancement
Need a feature to display info about the form and the questions in the new form base view. For the content the feature shall be similar to the info mode in the old views.

24318: Add filter options for the form audits for the form base view

uEDC Feature Enhancement
The form audits for the form base view should be able to be filtered with the same options that exists in the old system. The normal manager filter options do not apply for the form audit list as we do not want to filter on the content of the table, but on the kinds of lines that are displayed.

24319: Add filter options for the question audits for the form base view

uEDC Feature Enhancement
The question audits for the form base view should be able to be filtered with the same options that exists in the old system.

24320: Implement a group and question divider for the form base view

uEDC Feature Enhancement
Similar to the old UI the groups and questions (if configured) shall show a divider on the form base view. Current behavior for question dividers in the old UI is that only the first question’s “divider” property is used for the complete group. The new behavior should show the same functionality.

24321: Implement a warning, when the user tries to navigate away from the form base view

uEDC Feature Enhancement
There should be a warning and possibility for the user to confirm or cancel the navigation request when the user navigates away from a form if in dirty mode with pending data.

24322: Header of the form base view is a mockup and needs functionality

uEDC Feature Enhancement
The header of the form base view is a mockup that seems to look correct, but it does not have the required functionality. The header is implemented from element constructor “java\com\clickfind\responseErection\constructors\Header.java”. There is some java script code in “WEB-INF\js\formBaselet\header.js”. The current functionality with the ajax activity indicator and the two logos should be kept.

24324: Header menu of the form base view is a mockup and needs functionality

uEDC Feature Enhancement
The header menu of the form base view does not have the required functionality. There should be jsp that implements that tab for the JSP world. That functionality needs to be put into the element constructor.

24328: Preprocessing scripts need to be restricted to non-modifying command.

uEDC Feature Enhancement
The preprocess-ing script will be executed many times while the form is filled out from the user. It is important that the executed script command do not perform any changes.

24329: Show similar forms

uEDC Feature Enhancement
There should be an easy way to navigate to similar form with the form base view.

24772: The Actions menu of the header menu for the form base view requires randomization actions

uEDC Feature Enhancement
The randomization actions previously found in the demographics bar (old UI) need to be added to the form’s Actions popup menu.

24968: Partial editing capabilities for form base view

uEDC Feature Enhancement
The form base view for the Unified UI needs to be able to support partial editing similar to the old views “formPartialEdit”, “formPartialView” and “formRestrictEdit”.

Trial Design – App Properties
New App Properties:

  • roleName-allowForms – allows the specified role to have write access to all forms in the list
  • roleName-allowQuestions – allows the specified role to have write access to all questions in the list
  • roleName-restrictForms – prevents the specified role from having write access to all forms in the list
  • roleName-restrictQuestions – prevents the specified role from having write access to all questions in the list
  • hideInTree – hides all the forms specified in the list from all roles
  • hideInTreeRoleName – hides all forms specified in the list from the specified role

Accepted Values: comma-separated list of forms or questions
Example

NameValue
Coordinator-allowFormsco_summary,hemfu
Data Manager-allowQuestionschemstat
Data Manager-restrictFormschemc1d1,chemc1d8,ksdac1d1,ksdac1d15
Investigator-restrictQuestionsphotoyn,lbdt,chemlib
hideInTreeco_summary
hideInTreeCoordinatorco_summary2,cm_summary

Additional Notes
If Role Selection is not enabled and the user is assigned multiple roles, the user can be granted access to a form through any of the roles assigned to him or her.

See the new DTLC page on Partial Editing in the Unified interface for more information.

25061: The form base view requires a form summary for the child forms

uEDC Feature Enhancement
Child forms for the currently selected forms shall be displayed in a form summary.

25282: Audit filtering for tabular display

uEDC Feature Enhancement
The audits in the tabular display are shown as jquery dialog. Filtering should be enabled for this. Currently the filter button is display but without function.

27931: Upon closing the comment pop-up box, the value should be cleared

uEDC Feature Enhancement
If the comment pop-up box is closed, the comment value should be cleared before the page is reloaded.

28504 – DBP 13.0 Documentation

  • 29471: Update uSafety manual
  • 29472: Update uIRT manual
  • 29473: Update uTrain manual
  • 29474: Update uCTMS manual
  • 29475: Update uDesign manual
  • 29476: Create ERP manual
  • 29477: Update uEDC manual
  • 29478: DBP 13.0 Release Notes
  • 29480: Update the Subject Status help page
  • 29481: Update the Profile help page
  • 29482: Create a help page related to enrolling subjects
  • 29485: Update Subject Status Design documentation
  • 29486: Create a Casebook manual
  • 29487: Create a Desktop help page
  • 29488: Create a Study Homepage help page
  • 29489: Create a Managers manual
  • 29491: Create a Widgets manual
  • 29492: Create an Ad-Hoc Reports manual
  • 29493: Create a Standard Reports help page
  • 29494: Create a Partial Metadata help page
  • 29495: Create a Difference Manager help page
  • 29496: Create a Subset Exports help page
  • 29497: Create a Tabular Data Entry and Review help page
  • 29498: Update the Form Flow help page
  • 29499: Update the Email Notification help page
  • 29503: Create Partial Metadata Design help page
  • 29508: Create a Role Selection help page
  • 29530: Update Listener help page
  • 29531: Update the Enterprise Manager help page
  • 29532: Create Collaboration Tools manual
  • 29533: Update Security Features documentation
  • 29535: Update a set of Classic manuals
  • 29536: Update Classic uIRT manual
  • 29537: Create a Unified and Classic splash page
  • 29546: Update Security Features documentation for Classic UI
  • 29549: Create Text Editor help page
  • 29551: Update Email Template documentation for new UI
  • 29552: Update Email Template documentation for Classic UI
  • 29554: Update the Missing Data help page
  • 29555: Update the Form Flow design help page
  • 29556: Update the Dynamic Status design help page
  • 29557: Update the Tabular Display Config design help page
  • 29558: Update the study modifications design help page
  • 29559: Update the Double Data Entry design page
  • 29560: Create a Partial Editing Design page
  • 29561: Update the Fill Sample Data help page
  • 29562: Update the Additional Output help page
  • 29563: Update the Info Mode help page
  • 29564: Create Visit Manager design documentation
  • 29565: Update Multi-Lingual Clinical trials help page
  • 29566: Update Trial Manager manual
  • 29569: Update Dynamic Status help page
  • 29570: Update Study Modifications help page
  • 29576: Update Missing data help page for Classic UI
  • 29577: Update Form Flow design page for Classic UI
  • 29578: Update Form Flow help page for Classic UI
  • 29579: Update Email Notifications help page for the Classic UI
  • 29580: Update Tabular Display Configuration page for the Classic UI
  • 29581: Create Partial Metadata help page for the Classic UI
  • 29582: Create Partial Metadata design help page for the Classic UI
  • 29583: Update Subject Status Design help page for Classic UI
  • 29584: Update Subject Status help page for Classic UI
  • 29585: Update uSafety manual for the Classic UI
  • 29586: Update Enterprise Manager manual for the Classic UI
  • 29588: Update Trial Manager manual for the Classic documentation
  • 29589: Update Tabular Data Entry and Review help page for the Classic UI
  • 29636: Update Upgrade Dictionary Utility page
  • 29643: Update the New to DT Software Suite help page
  • 29644: Create a New to the Unified Interface help page
  • 29647: Create Product Splash pages
  • 29648: Update the New To Learning Center page
  • 29649: Update uEDC Getting Started help page
  • 29650: Create a help page describing how to switch interfaces
  • 29657: Create set of help pages related to the user quality score scripts
  • 29658: Update Checklist documentation for Classic UI to support data review checklist
  • 29659: Create custom export formatter page for data review status
  • 29662: Update the Exports help page
  • 29664: Update the Exports help page in the Classic UI
  • 29665: Update the App Properties help page for the Classic UI
  • 29666: Update the App Properties page for the Unified UI
  • 29668: Update the Roles help page for Unified UI
  • 29669: Update the Roles help page for the Classic UI
  • 29671: Update the Question Types Definition help page for Unified UI
  • 29672: Update the Question Types Definition help page for the Classic UI

Outstanding Issues

  • 11051: Recursive Forms gives inconsistent results.
  • 11120: OC4J holds onto message classes used with JGroups
  • 11126: User Profile Can Only Be Updated in Production Cluster
  • 11994: ‘Is Default’ can be answered ‘Yes’ for multiple portals
  • 12298: Problems if two users commit VA at the same time
  • 12541: Expression Assignment with a date or time field that has blank value gets wrong result
  • 12590: issue with form rename if a question used in naming is also referenced from another question
  • 12715: Large Trials hang when commiting in IE
  • 13023: When OC4J needs restarted it can hang in the “init” status
  • 13039: OC4J Deadlock occurs when invalidating distributed session
  • 13505: alert script behavior inconsistent when changing dependent question
  • 13614: DataGenie: contact control should resolve to user name
  • 13980: deleteting of application properties is not synchronized between the servers.
  • 14029: Script-Errors not displayed for “after” scripts
  • 14042: RuntimeException when delete difference report archive
  • 15138: Definition XML is reloaded when Fill Sample Data action is used.
  • 15616: Cannot add user to workgroup from client EM
  • 15962: The file history event name and comments are English only
  • 16417: Restriction on Start and End Levels should work in Search Results
  • 16646: Dynamic created Synonym Dictionary does not come up in search.
  • 16859: Audits of type OLD are still being written.
  • 16890: script’s commands under “text” tag are getting executed even when “expression” tag returns “true”
  • 17064: issue with clear question’s sdv boxes
  • 17135: DA: Remove Visit Schedule granted permission
  • 17253: Nested functions do not parse correctly
  • 17255: Many of the export parameters do not function inside CustomFormFormatter
  • 17328: Can’t add users to Test,Design,Approve
  • 17394: Click OS after you click Advanced Filters Show or Hide
  • 17476: Audits of type missing data not available for filtering
  • 17498: CODE_FIELD_ACTIVE_STATUS key should be added to the Code Manager Audit
  • 17508: Audit Manager Export issues
  • 17527: With large Case Books sequencing of forms is out of order in some cases
  • 17540: Lists of roles in EM do not match between servers
  • 17545: Total time spent for a parent activity not calculated correctly sometimes
  • 17582: PDFCrfWriter has two help links that do not exist in the new help center Trial Manager manual
  • 18683: Freeze scripts are not shown in form debug page
  • 18913: Secure the user interface to not allow adding invalid chars
  • 19268: Data Gene “error in expression”
  • 19384: Duplicate translation keys
  • 19548: “Reconcile (Process Assignments)” allows script assignment
  • 19706: createForm command issue
  • 19736: scripts are not processed upon reconcile
  • 20060: issue with “name” dependency
  • 20277: Exception when forms modified simultaneously in zoom mode
  • 20491: Improve Area Chart on Opera, Safari
  • 20492: Improve Scatter Chart
  • 20493: If the report is included on the application’s home page, everyone with access to the application will be able to view it
  • 20742: Integer edit checks must be surrounded by quotes
  • 21405: User Can Manipulate Multiple Browsers To Edit Plain Text Questions
  • 21494: Lab range was displayed for wrong question type
  • 21674: When the toolname is numeric only it drops leading zeros
  • 21746: Resolved values in the expression language are parsed and interpreted
  • 21849: Dropdown lists move when highlighted in VA
  • 22244: In VA, dropdown menu stays in place on browser resize
  • 22279: closing query window will not submit the parent in Opera
  • 22287: VA Icons not displayed properly
  • 22291: VA delete does not work in IE
  • 22309: ‘Paste Item’ in Visual Architect does not work until you publish or commit trial
  • 22488: Email Notification cause import to fail
  • 23118: Dynamic formIds are incremented
  • 23481: Synonym Manager Export gives clickOS error
  • 23525: issues with notSet missing data flag
  • 24208: Inserted Form Display Sequence Incorrect
  • 24378: Cannot change Export Type
  • 24380: Some characters cause errors
  • 24609: Chrome and Safari do not save data when SaveOnExit is yes
  • 24628: In zoom mode ‘Lock’ and ‘Lock All’ do not disable Close/Open Alert boxes
  • 24639: ‘enterKeyAction’: unresolved issues from Bug 24210
  • 24679: Data is not saved when broweser window is closed in Opera browser
  • 24684: In Zoom mode extra button click is required to get back to container
  • 25162: uIRT Reports > Shipment Summary report > Shipment Counts – does not display ‘Shipments Partially at Destination’.
  • 26598: Managers screens jump left
  • 26608: Close button on View Audit screen does not work in Safari and Opera
  • 26609: During Cancel Shipment process the OK button does not work in Opera
  • 26610: During Shipment Confirmation process the OK button does not work in Opera
  • 26611: PDF Export of Deleted Subjects With Same Subject ID Should Produce Appended File
  • 27187: Announcements will have delay before being synced
  • 27492: Several places missing horizontal scroll bar for the small screens
  • 28521: forwardToNextForm causes Branching Not to Work
  • 29302: Trial Manager roles not related to uCTMS have an access to the uCTMS exports
  • 29355: Form Flow Transition page is not refreshed correctly.
  • 29365: characters not displaying properly in SAS database due to utf-8 encoding
  • 29378: Exception Is Thrown In Testing Manager
  • 29423: Exception thrown when viewing query if query permissions are not defined
  • 29652: Dependency variable evaluation can fail depending on date format
  • 29729: Performance issues
  • 29730: EULA Modification of Chinese Taiwan shows English in preview
  • 29785: ‘Union Report’ does not see the copies of the ‘testMathStrings’ report
  • 29819: poor performance in zoom mode in UI2012
  • 30045: Alert might not fire when some RFC is missing
  • 30728: “Duplicate Display ID Correction Utility” comment does not have translation key
  • 30815: IE artifacts during slide toggle on homepage
  • 30864: Alerts can be created on questions with touch count of 0
  • 30991: Function ‘Length’ of Ad-hoc report does not work properly
  • 31244: Query text can’t be updated anymore
  • 31253: Translation in the actions menu are not generated properly
  • 31478: DATE_FORMAT if set decrements values in Visits manager
  • 31479: Basic Setup in Visual Architect Library Panel does not have “Overwrite Design” option

DCCS Billing Tool Outstanding Issues

  • 23219: reports windows should be re-sized dynamically
  • 23362: Export issue for reports with Data Item Count Restriction
  • 27533: Report tables expand to surrounding table size + scrollbar width

uCTMS Outstanding Issues

  • 22862: sitePharmacyAddressSame displayed unchecked when imported
  • 22876: Exported file from uCTMS reports has not standard format
  • 22883: Sorting should be done across all pages.
  • 22891: All CTMS reports should show tooltips for the cells
  • 23282: Pie chart legends do not show all values in several reports
  • 23915: uIRT Reports Choose All Sites Tool Incorrectly
  • 27644: “Schedule of Events” Report has incorrect table chart

uIRT Outstanding Issues

  • 18983: RuntimeException when change Assignment Type to sequential
  • 27590: In Drug assignments restriction to sites should be applied regarding to Global Permissions
  • 27633: “Email Subject” issue for inventory transfer email
  • 27671: Schedule manager Site filter should show all sites
  • 26953: Compiler should trigger only 1 error

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