Summary
This article covers the 14.0.0 DBP Release notes.
DATATRAK ONE® 14.0.3 – February 3, 2017
For 14.0.3, we have a total of four (4) correction items outlined below.
14.0.3 Corrections
For 14.0.3, we have included the four (4) correction items outlined below:
Apply Charset restriction to form and record RFC [Ticket 181583|UX EDC & Medical Coding|Data Entry & Cleaning]
Applying the Charset Restriction to the form and record Reason For Change field.
Audits should be created for the questions at the time when dialog is saved [Ticket 182274|UX CTMS 360|CTMS - Audits]
Correcting an issue where audits are not created for data values populated in a CTMS dialog.
Dictionary upgrade utility never completes [Ticket 182270|UX EDC & Medical Coding|Medical Coding]
Correcting an issue when the Medical Coding Dictionary upgrade utility is executed with questions locked the utility does not end.
Question Audit Manager Loading results on First Entry [Ticket 182281|UX EDC & Medical Coding|Managers]
Correcting an issue where the Question Audit Manager is performing a search upon entry to the manager.
DATATRAK ONE® 14.0.2 – December 20, 2016
For 14.0.2, we have a total of two (2) updates including maintenance and correction items outlined below.
14.0.2 Corrections
For 14.0.2, we have included the one (1) correction item outlined below:
Approve Servers Not Sync with CTMS Settings [Ticket 181533|UX CTMS 360|CTMS]
UX CTMS 360 Settings updated to sync all approve servers when setting updates are made.
14.0.2 Maintenance
For 14.0.2, we have included the one (1) maintenance item outlined below:
Add second staging Approve server [Ticket 181553|DATATRAK ONE|Systems]
Added a new approve server to the staging environment.
DATATRAK ONE® 14.0.1 – December 9, 2016
For 14.0.1, we have a total of six (6) updates including enhancement, maintenance, and correction items outlined below.
14.0.1 Enhancements
For 14.0.1, we have included the one (1) enhancement item outlined below:
Blank Edit Checks do not Display Missing Data Flags [Ticket 181308|UX EDC & Medical Coding|Data Entry & Cleaning]
The Missing Data flags will work with the Blank Check Preferred configuration.
14.0.1 Corrections
For 14.0.1, we have included the two (2) correction items outlined below:
User accounts can be created with no preferred language [Ticket 181304|DATATRAK ONE|Enterprise Manager]
Preventing accounts from being created without a preferred language.
The Check Blank property triggers alerts on blank forms when a script assignment is used [Ticket 181322|UX EDC & Medical Coding|Data Entry & Cleaning]
Preventing the Blank Check from firing when accessed via cross-form assignment scripts.
14.0.1 Maintenance
For 14.0.1, we have included the three (3) maintenance items outlined below:
Improve Quartz Scheduler logging [Ticket 181112|DATATRAK ONE|Scheduler]
Adding and improving system logs generated by the Scheduler jobs.
View User Detail Screen performance issues [Ticket 181305|DATATRAK ONE|Enterprise Manager]
Improving performance of the View User Detail Screen.
Update properties files [Ticket 181340|DATATRAK ONE|Systems]
Updating properties files to contain correct staging server references.
DATATRAK ONE® 14.0.0 – November 27, 2016
For the 14.0.0 Release, we have a total of three hundred and fifty (350) updates including enhancement, maintenance, and correction items outlined below.
UX CTMS 360 (Enhancements)
The 14.0.0 release contains the initial release of UX CTMS 360. The sections of the UX CTMS 360 release are as follows:
CTMS Settings
For UX CTMS Settings, we have included the eleven (11) items outlined below:
CTMS Edit Form [Ticket 62059|UX CTMS 360|CTMS - Settings]
The Edit Form allows users the ability to change the order of questions, update existing questions and add new questions to CTMS forms.
CTMS Logic Check & Visibility Form [Ticket 62060|UX CTMS 360|CTMS - Settings]
The Logic Check & Visibility Form allows users the ability to change visibility and edit check settings for each question on the CTMS forms.
CTMS Settings [Ticket 62064|UX CTMS 360|CTMS - Settings]
The UX CTMS Settings allows users to design and modify UX CTMS 360 to fit client’s specifications through an easy to use interface.
CTMS Versions [Ticket 62065|UX CTMS 360|CTMS - Settings]
The Publish Version Manager allows clients to deploy CTMS settings to the production server.
CTMS Managed List [Ticket 62103|UX CTMS 360|CTMS - Settings]
The Managed List allows users the ability to add, edit or remove answer options for defined list.
Configurable Multi Document Field [Ticket 134083|UX CTMS 360|CTMS - Study Manager - Plans]
A Multi Document Field question type can be added to CTMS forms.
CTMS Settings Menu [Ticket 135669|UX CTMS 360|CTMS - Settings]
The CTMS Setting section contains a menu tree for navigation.
CTMS Display Text [Ticket 139857|UX CTMS 360|CTMS - Settings]
The CTMS default display text displays unless the configuration settings are changes.
CTMS Default Changes [Ticket 150261|UX CTMS 360|CTMS - Settings]
CTMS default settings can be updated in future releases.
Import Settings [Ticket 172159|UX CTMS 360|CTMS - Settings]
The ability to define how imports handle unrecognizable fields is managed in the UX CTMS Settings
Multiline Text to Configurable Fields [Ticket 175807|UX CTMS 360|CTMS - Settings]
A Multiline text field can be added to configurable forms.
Product Management
For UX CTMS Product Management, we have included the two (2) items outlined below:
Product Form [Ticket 62055|UX CTMS 360|CTMS - Product Management]
Products used in studies are managed in UX CTMS by the Product form.
Product Manager [Ticket 62057|UX CTMS 360|CTMS - Product Management]
The Products Manager allows for the storage and tracking of products tested in studies.
Site Management
For UX CTMS Site Management, we have included the fifteen (15) items outlined below:
Site Form [Ticket 62056|UX CTMS 360|CTMS - Site Management]
Sites used in studies are managed in UX CTMS by the Site Form.
Site Manager [Ticket 62058|UX CTMS 360|CTMS - Site Management]
The Site Manager allows for the storage and tracking of all sites associated to studies.
Study Management – Site Menu [Ticket 132815|UX CTMS 360|CTMS - Study Manager - Site Selection]
Sites can be added to Studies and the study will contain a Site menu.
Add Site Dialog [Ticket 132816|UX CTMS 360|CTMS - Study Manager - Site Selection]
Sites can be added to Studies through the Add Site to Study dialog.
Site Sub-Menu [Ticket 132817|UX CTMS 360|CTMS - Study Manager - Site Selection]
Study Sites contain a sub menu.
Study Site Form [Ticket 132818|UX CTMS 360|CTMS - Study Manager - Site Selection]
The Study Site information is managed through the Study Site Form.
Site Personnel Form [Ticket 132819|UX CTMS 360|CTMS - Study Manager - Site Selection]
Site Personnel working on the study is managed through the Site Personnel form.
Site Feasibility Form [Ticket 132820|UX CTMS 360|CTMS - Study Manager - Site Selection]
Site Feasibility collected for studies is managed through the Site Feasibility form.
Site Contract & Budget Menu [Ticket 132821|UX CTMS 360|CTMS - Study Manager - Site Selection]
Site Contract and Budget menu will appear for the Site sub-menu when a Site Contract is added.
Add Site Contract [Ticket 132824|UX CTMS 360|CTMS - Study Manager - Site Selection]
The site contracts for each study site is managed through the Site Contract form.
Site Budget Form [Ticket 132825|UX CTMS 360|CTMS - Study Manager - Site Selection]
The site budgets for each study site is managed through the Site Budget form.
Site Feasibility Templates [Ticket 132829|UX CTMS 360|CTMS - Study Manager - Site Selection]
Site Feasibility Templates allow users to configure in UX CTMS Settings templates that can be used to collect site feasibility.
Site Enrollment [Ticket 134417|UX CTMS 360|CTMS - Study Manager - Site Selection]
The site enrollment for each study site is managed through the Site Enrollment form.
Populate Site Manager with Study Data [Ticket 135751|UX CTMS 360|CTMS - Site Management]
The Site Manager contains columns populated based on the studies the site is participating in, completed studies and the assigned Principal Investigator.
Order Site Enrollment Table based on Visit Schedule Table [Ticket 175025|UX CTMS 360|CTMS - Study Manager - Site Selection]
The Site Enrollment table displays in the order of the Patient Status in the Visit Schedule.
Personnel Management
For UX CTMS Personnel Management, we have included the thirteen (13) items outlined below:
Personnel Manager [Ticket 122314|UX CTMS 360|CTMS - Personnel Management]
The Personnel Manager allows for the storage and tracking of all personnel associated to studies, sites and vendors.
Personnel Form [Ticket 122315|UX CTMS 360|CTMS - Personnel Management]
Personnel who work on studies are managed in UX CTMS by the Personnel form.
Create DATATRAK ONE Accounts from Personnel Records [Ticket 122316|UX CTMS 360|CTMS - Personnel Management]
A DATATRAK ONE user account can be created for any personnel record within the Personnel Manager. The system will generate the account and send email notification to the personnel record upon the account generation.
Studies Column in Personnel Manager [Ticket 135754|UX CTMS 360|CTMS - Personnel Management]
The Personnel Manager contains a Studies column with all studies the personnel has participated in.
Study Personnel Form [Ticket 135706|UX CTMS 360|CTMS - Study Manager - Monitoring]
Study Personnel working on a study is managed through the Study Personnel form.
Add Study Personnel [Ticket 135707|UX CTMS 360|CTMS - Study Manager - Monitoring]
Study Personnel can be added to the Study Personnel form.
Personnel Documentation Form [Ticket 140412|UX CTMS 360|CTMS - Personnel Management]
Personnel Documentation can be added to Personnel records.
Add Documents/Update Documents Properties [Ticket 140413|UX CTMS 360|CTMS - Personnel Management]
Document properties can be added or updated to Personnel Documentation forms.
Personnel Documentation Update Document [Ticket 140414|UX CTMS 360|CTMS - Personnel Management]
Document files can be added or updated to Personnel Documentation forms.
Personnel Documentation Delete Document [Ticket 140415|UX CTMS 360|CTMS - Personnel Management]
Document files can be deleted from Personnel Documentation forms.
List Site Personnel Documents [Ticket 140417|UX CTMS 360|CTMS - Personnel Management]
Personnel Documentation are listed for reference on the Study Regulatory Body Screen.
Navigation Menu for Personnel Screen [Ticket 150268|UX CTMS 360|CTMS - Personnel Management]
The Personnel Screen contains a menu tree for navigation.
Link an Existing DATATRAK ONE Accounts to a Personnel Records [Ticket 164395|UX CTMS 360|CTMS - Personnel Management]
A DATATRAK ONE user account can be linked to a personnel record. Once linked the Personnel form will populate with the user information from the user’s profile. The fields that are populated from the user’s account will become read-only and automatically update when the users profile is updated.
Study Management
For UX CTMS Study Management, we have included the forty (40) items outlined below:
Study Form [Ticket 132813|UX CTMS 360|CTMS - Study Management]
Studies are managed in UX CTMS by the Study Form.
Studies Manager [Ticket 132814|UX CTMS 360|CTMS - Study Management]
The Studies Manager provides a high level overview of the studies currently enrolled within UX CTMS.
Create Study in UX EDC [Ticket 132827|UX CTMS 360|CTMS - Study Manager - Site Selection]
Trial Manager study records can be created from UX CTMS when using UX CTMS and UX EDC Together.
Packaging & Shipment Plans Form [Ticket 132832|UX CTMS 360|CTMS - Study Manager - Plans]
Packaging & Shipping plans for studies are managed in UX CTMS by the Packaging & Shipping Plans form.
Data Management Plan Form [Ticket 132833|UX CTMS 360|CTMS - Study Manager - Plans]
Data Management Plans for studies are managed in UX CTMS by the Data Management form.
Visit Schedule Form [Ticket 132834|UX CTMS 360|CTMS - Study Manager - Plans]
Questions to collect for patients, patient status, visit schedule and other study-specific attributes that are used throughout the study are managed in UX CTMS by the Visit Schedule.
Visit Data Form [Ticket 132835|UX CTMS 360|CTMS - Study Manager - Plans]
Visit Data questions to collect for the study is collected on the Visit Data form through the Visit Schedule.
Project Planning Form [Ticket 132836|UX CTMS 360|CTMS - Study Manager - Plans]
The plans for the study, site and patient enrollment are managed in UX CTMS by the Project Plan form.
Site Setup Table [Ticket 132837|UX CTMS 360|CTMS - Study Manager - Plans]
Site plans for expected versus actual countries and sites are managed in UX CTMS by the Site Setup table on the Project Plan Form.
Patient Status Table [Ticket 132838|UX CTMS 360|CTMS - Study Manager - Plans]
Patient Status enrollment plans for expected versus actual patients per status are managed in UX CTMS by the Patient Status table on the Project Plan form.
Study Table [Ticket 132841|UX CTMS 360|CTMS - Study Manager - Plans]
Study plans for expected versus actual CRAs, duration and eCRFs are managed in UX CTMS by the Study Setup table on the Project Plan form.
Study Budgets Screen [Ticket 135662|UX CTMS 360|CTMS - Study Manager - Budget]
Study level budgets for the study are managed through the Study Budget form.
Site Payment Approvals Manager [Ticket 135664|UX CTMS 360|CTMS - Budget Manager]
The Site Payment Approvals Manager gives a single location to view site payments across all studies.
Site Payment Details Screen [Ticket 135665|UX CTMS 360|CTMS - Budget Manager]
The Site Payment Details Screen will list each Site Specific Budget item and Visit Payment item for each patients.
Site Payment Approvals [Ticket 135666|UX CTMS 360|CTMS - Budget Manager]
The Site Payment Approvals Manager allows all pending payment items to be set to the approve status.
Site Payment Rejections [Ticket 135667|UX CTMS 360|CTMS - Budget Manager]
The Site Payment Approvals Manager allows all pending payment items to be set to the reject status.
Site Payment Clear Approve/Reject [Ticket 135668|UX CTMS 360|CTMS - Budget Manager]
The Site Payment Approvals Manager allows all approve and reject status items to be cleared and the status sets back to pending.
Site Payments Manager Screen [Ticket 135672|UX CTMS 360|CTMS - Budget Manager]
In the Site Payments Manager approved payments can be tracked, allowing you to see how much is owed to each Study Site and the payment terms associated with their contract.
Payment Details Screen [Ticket 135673|UX CTMS 360|CTMS - Budget Manager]
The Payment Details Screen will list each Site Specific Budget item and Visit Payment item for each patients with an Approve status from the Site Payment Approvals Manager.
Make Payment [Ticket 135674|UX CTMS 360|CTMS - Budget Manager]
The Site Payments Manager allows all approved payment items to be set to the paid status.
Unpaid Payment [Ticket 135675|UX CTMS 360|CTMS - Budget Manager]
The Site Payments Manager allows all approved payment items to be set to the unpaid status.
Deviation Transition [Ticket 135681|UX CTMS 360|CTMS - Study Manager - Patients]
The Deviation Transitions section allows users to configure the transition statuses for a deviation workflow through the Deviation Transitions.
Add Deviation Transition Status [Ticket 135682|UX CTMS 360|CTMS - Study Manager - Patients]
Add Deviation Transitions to define the steps that will be used in the workflow through the Deviation Transitions.
Deviation Workflow [Ticket 135685|UX CTMS 360|CTMS - Study Manager - Patients]
A Deviation Workflow defines the steps that a deviation will go through during review and finalization.
Add Deviation Workflow Transition [Ticket 135692|UX CTMS 360|CTMS - Study Manager - Patients]
Add Deviation Workflow Transitions to define the order and properties that will be used in the workflow through the Deviation Workflow.
Add Deviation [Ticket 135698|UX CTMS 360|CTMS - Study Manager - Patients]
Study deviations can be added to a study through the Deviation Form.
Study Deviations [Ticket 135699|UX CTMS 360|CTMS - Study Manager - Patients]
All study deviations are listed and can be viewed through the Study Deviations screen.
Transition Deviation Report [Ticket 135700|UX CTMS 360|CTMS - Study Manager - Patients]
Study deviations are transitioned through the deviation workflow with the Deviation Transitions screen.
Deviation Manager [Ticket 135701|UX CTMS 360|CTMS - Study Manager - Patients]
The Deviation Manager stores and tracks all deviations associated to studies.
Patient Summary [Ticket 135702|UX CTMS 360|CTMS - Study Manager - Patients]
Patients are managed through the Patients summery form, it is from this screen that patients can be accessed or added.
Patient Form [Ticket 135703|UX CTMS 360|CTMS - Study Manager - Patients]
Patient data is collected through the Patient form.
Actual/Expected Patients Column Studies Manager [Ticket 135750|UX CTMS 360|CTMS - Study Management]
The Studies Manager contains an Actual/Expected Patients column which displays expected versus actual patient in the study.
Study Navigation Tree [Ticket 136907|UX CTMS 360|CTMS - Study Management]
Studies contain a navigation tree.
Activate Visit Data [Ticket 145111|UX CTMS 360|CTMS - Study Manager - Plans]
The Visit Data settings must be activated through the Activate Visit Data, for the visit data to be accessible throughout the study.
Visit Payment Schedule [Ticket 165174|UX CTMS 360|CTMS - Study Management]
The Visit Payment Schedule table collects the budget for the site items and each Patient Status.
Link CTMS Study to EDC [Ticket 168329|UX CTMS 360|CTMS - Study Management]
CTMS Studies are linked to EDC studies through Trial Manager study creation or linking an existing study in EDC to a CTMS study.
Link CTMS Study Site to EDC [Ticket 168330|UX CTMS 360|CTMS - Study Management]
CTMS Sites are linked to EDC sites through Trial Manager site creation or linking an existing site in EDC to a CTMS site.
Remove CTMS Study and CTMS Site Links from EDC [Ticket 168332|UX CTMS 360|CTMS - Study Management]
Linked studies and sites can be unlinked.
Patients Created/Removed when Linking to EDC Site [Ticket 169821|UX CTMS 360|CTMS - Study Manager - Patients]
Patient records are created when a CTMS Site is Linked to an EDC Site and removed when unlinked.
Unique ID to Add Study Form and Manager [Ticket 176546|UX CTMS 360|CTMS - Study Management]
The Add Study Form and Study Manager contain the Unique ID field.
Vendor Management
For UX CTMS Vendor Management, we have included the twenty-two (22) items outlined below:
Vendor Form [Ticket 118550|UX CTMS 360|CTMS - Vendor Manager - Personnel]
Vendors who work on studies are managed in UX CTMS by the Vendor form.
Vendor Manager [Ticket 118551|UX CTMS 360|CTMS - Vendor Manager - Personnel]
The Vendor Manager allows for the storage and tracking of all vendors associated to studies.
Study Management Vendor Menu [Ticket 131451|UX CTMS 360|CTMS - Study Manager - Vendor]
Vendors can be added to Studies and the study will contain a Vendor menu.
Add Study Vendor Dialog [Ticket 131452|UX CTMS 360|CTMS - Study Manager - Vendor]
Vendors can be added to Studies through the Add Vendor to Study dialog.
Study Vendor Form [Ticket 131453|UX CTMS 360|CTMS - Study Manager - Vendor]
The Study Vendor information is managed through the Study Vendor Form.
Vendor Personnel Form [Ticket 131454|UX CTMS 360|CTMS - Study Manager - Vendor]
Vendor personnel working on the study is managed through the Vendor Personnel form.
Vendor Contract & Budget [Ticket 131681|UX CTMS 360|CTMS - Study Manager - Vendor]
Vendor level contracts used for studies are managed in UX CTMS by the Study Vendor Contract & Budget form.
Vendor Level Contract [Ticket 131682|UX CTMS 360|CTMS - Study Manager - Vendor]
Vendor study level contracts are managed in UX CTMS by the Study Vendor Contract form.
Vendor Budget Form [Ticket 131683|UX CTMS 360|CTMS - Study Manager - Vendor]
Vendor budgets at a study level are managed in UX CTMS by the Add Vendor Budget form.
Vendor Menu & Actions [Ticket 131686|UX CTMS 360|CTMS - Vendor Manager - Contracts]
The Vendor form contains a menu tree for navigation and action menu options to create Audit and Contract records.
Currency Question [Ticket 131687|UX CTMS 360|CTMS - Vendor Manager - Contracts]
Currency with Country indication question type created.
Vendor Audit Form [Ticket 131689|UX CTMS 360|CTMS - Study Manager - Vendor]
Vendors Audits are managed in UX CTMS by the Vendor Audit form.
Vendor Contract Form [Ticket 131690|UX CTMS 360|CTMS - Vendor Manager - Contracts]
Vendor level contracts are managed in UX CTMS by the Vendor Contract form.
Vendor Payment Terms Form [Ticket 131691|UX CTMS 360|CTMS - Vendor Manager - Contracts]
Vendor Payment Terms of vendor level contracts are managed in UX CTMS by the Vendor Payment Term form.
Vendor Invoice Form [Ticket 131692|UX CTMS 360|CTMS - Vendor Manager - Contracts]
Vendor Invoice of vendor level contracts are managed in UX CTMS by the Vendor Invoice form.
Vendor Audit Manager [Ticket 131693|UX CTMS 360|CTMS - Vendor Manager - Contracts]
The Vendor Audit Manager allows for the storage and tracking of all vendor audits.
Vendor Contract Manager [Ticket 131694|UX CTMS 360|CTMS - Vendor Manager - Contracts]
The Vendor Contract Manager allows for the storage and tracking of all vendor level contracts.
Vendor Payment Manager [Ticket 131695|UX CTMS 360|CTMS - Study Manager - Vendor]
The Vendor Payment Manager allows for the storage and tracking of all vendor payments and invoices.
Personnel Select Field [Ticket 131744|UX CTMS 360|CTMS - Vendor Manager - Personnel]
Personnel records can be linked to Vendors and Sites through the Personnel Select Field.
Vendors Dialog [Ticket 132830|UX CTMS 360|CTMS - Study Manager - Vendor]
A Vendors Dialog allows the selection of vendors from the Vendors Manager.
Range Filter for Managers [Ticket 137244|UX CTMS 360|CTMS - Vendor Manager - Contracts]
Currency questions displayed on managers will contain a range filter options.
Remove Vendors from Studies [Ticket 169036|UX CTMS 360|CTMS - Study Manager - Vendor]
Study Vendors can be removed from studies.
Regulatory Management
For UX CTMS Regulatory Management, we have included the thirty-eight (38) items outlined below:
Regulatory Body Manager [Ticket 62061|UX CTMS 360|CTMS - Regulatory Requirements]
The Regulatory Bodies Manager displays all regulatory authorities stored in the system.
Regulatory Requirements Manager [Ticket 62062|UX CTMS 360|CTMS - Regulatory Requirements]
The Regulatory Requirements Manager displays all standard requirement sets that have been created.
Add Regulatory Bodies [Ticket 62104|UX CTMS 360|CTMS - Regulatory Requirements]
Regulatory Bodies reported to on studies are managed in UX CTMS by the Regulatory Body Screen.
Add/Edit Regulatory Category [Ticket 62105|UX CTMS 360|CTMS - Regulatory Requirements]
Regulatory Categories can be added through the Regulatory Category Screen.
Edit Regulatory Bodies [Ticket 118534|UX CTMS 360|CTMS - Regulatory Requirements]
Regulatory Bodies can be edited on the Regulatory Body Screen.
Delete Regulatory Category [Ticket 118536|UX CTMS 360|CTMS - Regulatory Requirements]
A Regulatory Category can be deleted through the Regulatory Categories table.
Regulatory Navigation Tree [Ticket 118537|UX CTMS 360|CTMS - Regulatory Requirements]
A navigation tree exists for regulatory within a study.
Standard Requirement Sets Screen [Ticket 118538|UX CTMS 360|CTMS - Regulatory Requirements]
The Standard Requirement Sets screen is a location in the system where requirement sets can be built and configured.
Add Regulatory Bodies to Study [Ticket 118539|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
Regulatory Bodies are added to studies by the Add Regulatory Bodies action.
Delete Regulatory Bodies from a Study [Ticket 118540|UX CTMS 360|CTMS - Regulatory Requirements]
Regulatory Bodies can be removed from a study by the Delete Choose an Action Press Go option.
Study Regulatory Body Screen [Ticket 118541|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
The Study Regulatory Body Screen manages the regulatory body study level information.
Study Regulatory Requirements Screen [Ticket 118542|UX CTMS 360|CTMS - Regulatory Requirements]
The Study Requirement Set Screen is where data collection for regulatory submissions occurs.
Downloading Standard Requirements Templates [Ticket 118543|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
An excel template, to configure requirements set, can be downloaded through the Download Structure Template action.
Importing and Exporting Values [Ticket 118546|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
The data entered into requirement sets within a submission can be imported or exported through the Importing and Export Values actions.
Regulatory Category Form [Ticket 135414|UX CTMS 360|CTMS - Regulatory Requirements]
Regulatory Categories are managed in UX CTMS by the Regulatory Category Screen.
Requirement Set Form [Ticket 135415|UX CTMS 360|CTMS - Regulatory Requirements]
Regulatory Requirement sets are managed in UX CTMS by the Standard Requirement Sets screen.
Load Requirements Action [Ticket 135416|UX CTMS 360|CTMS - Regulatory Requirements]
New requirement sets can be added by Loading Requirements.
Export Configuration Action [Ticket 135417|UX CTMS 360|CTMS - Regulatory Requirements]
The data entered into requirement sets within a submission can be exported through the Export Values action.
Create Requirement Set [Ticket 135418|UX CTMS 360|CTMS - Regulatory Requirements]
Requirement Sets can be created through standard sets or study requirement sets.
Edit Regulatory Category Screen [Ticket 135421|UX CTMS 360|CTMS - Regulatory Requirements]
The Regulatory Category Screen can be edited.
Share Existing Requirement Sets [Ticket 135422|UX CTMS 360|CTMS - Regulatory Requirements]
Existing Requirement Sets can be shared within Regulatory Categories or Regulatory Submissions.
Instruction Worksheet on Requirements Template [Ticket 136505|UX CTMS 360|CTMS - Regulatory Requirements]
The Requirement Template contains an instruction worksheet.
Study Regulatory Requirements Manager [Ticket 137245|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
Study requirement sets are displayed on the Manage Requirements Screen in a manager table.
Add Shared Standard Set [Ticket 137300|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
A standard set can be shared for a study through the Manage Requirements Screen.
New Shared Set Dialog [Ticket 137301|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
A new requirement set can be added for a study through the Manage Requirements Screen.
Add Study Regulatory Bodies Dialog [Ticket 137302|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
Regulatory Bodies are added to studies by a dialog when the Add Regulatory Bodies action is selected.
Edit Regulatory Submission [Ticket 137309|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
The Regulatory Submission screen can be edited.
Delete Requirement Set from Regulatory Submission [Ticket 137310|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
Requirement Sets can be deleted from Regulatory Submissions through the Requirement Set Table.
Add Standard Requirement Set to Study Submission [Ticket 137311|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
Standard Requirement Sets can be added to Regulatory Submissions.
Share Existing Requirement Sets for Regulatory Submission [Ticket 137312|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
Existing submission requirements and standard requirements set can be shared for Regulatory Submissions.
Create and Edit Regulatory Submission [Ticket 137315|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
The Add Submission Screen is a form that is used for both submissions and amendments that have been added to the study.
Manage Regulatory Submissions [Ticket 137318|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
All regulatory submissions for a study are tracked on the Manage Submissions Screen.
Submit Regulatory Submission [Ticket 137319|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
Regulatory submissions submitted for a study are tracked through the Manage Submissions Screen.
Remove Regulatory Submission Submitted Status [Ticket 137320|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
Regulatory submissions submitted status can be removed on the Manage Submissions Screen.
Restore Regulatory Submissions [Ticket 137321|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
A deleted regulatory submission can be restored on the Manage Submissions Screen.
Associated Sites Field to Regulatory Submission Form [Ticket 150260|UX CTMS 360|CTMS - Regulatory Requirements]
The associated Site field appears on the Submission Screen.
Status Column on Manage Submission Screen [Ticket 169691|UX CTMS 360|CTMS - Regulatory Requirements]
The Manage Submissions Screen contains a status column that displays the submission status for the submission.
Extraction of Submission Documents [Ticket 177386|UX CTMS 360|CTMS - Study Manager - Regulatory Submissions]
The Add/Edit Submissions Screen contains an action to download all documents attached to regulatory sets in the submission.
Milestone Management
For UX CTMS Milestone Management, we have included the thirteen (13) items outlined below:
Milestone Manager [Ticket 131427|UX CTMS 360|CTMS - Study Manager - Milestones]
The Milestone Manager displays all milestones associated to studies.
Standard Milestone in Settings [Ticket 131442|UX CTMS 360|CTMS - Study Manager - Milestones]
Default standard milestones can be defined in CTMS Settings Standard Milestones to add to each study.
Delete Standard Milestone [Ticket 131443|UX CTMS 360|CTMS - Study Manager - Milestones]
Standard Milestones can be removed from the CTMS Settings Standard Milestones.
Create Standard Milestone [Ticket 131446|UX CTMS 360|CTMS - Study Manager - Milestones]
Standard Milestones can be added through the Add Milestones Dialog.
Study Milestones [Ticket 131447|UX CTMS 360|CTMS - Study Manager - Milestones]
The Study Milestones form allows the ability to define the milestones for the specific study.
Delete Study Milestone [Ticket 131448|UX CTMS 360|CTMS - Study Manager - Milestones]
Study Milestones can be deleted from a study.
Update Study Milestone [Ticket 131449|UX CTMS 360|CTMS - Study Manager - Milestones]
The projected or completion date can be updated for the Study Milestones.
Add Study Milestone [Ticket 131450|UX CTMS 360|CTMS - Study Manager - Milestones]
Study Milestones can be added to a study through Add Study Milestones.
Site Milestone Configuration Screen [Ticket 140150|UX CTMS 360|CTMS - Study Manager - Milestones]
Site Milestones allows the ability to define milestones that will be tracked for each site.
Site Specific Milestone Screen [Ticket 140153|UX CTMS 360|CTMS - Study Manager - Milestones]
Site Milestones configured at the Clinical Plans level appears for each site to track the milestone for the site through the Site Level Milestones.
Modify Site Specific Milestone [Ticket 140154|UX CTMS 360|CTMS - Study Manager - Milestones]
Site Milestones can be defined and collected at the site level through the Site Level Milestones.
Calculate Actual Date for Milestones based on EDC Events [Ticket 153032|UX CTMS 360|CTMS - Study Manager - Milestones]
EDC Events that occur in UX EDC will auto-populate the actual date for milestones.
Site Milestones in Milestone Manager [Ticket 175258|UX CTMS 360|CTMS - Study Manager - Milestones]
The Milestone Manager contains Site milestones and a site column.
Monitoring
For UX CTMS Monitoring, we have included the twenty (20) items outlined below:
Monitoring Report Transition Screen [Ticket 135695|UX CTMS 360|CTMS - Study Manager - Monitoring]
The Monitoring Report Transitions section allows users to configure the transition statuses for a monitoring report workflow through the Monitoring Report Transitions.
Add Monitoring Report Transition Status [Ticket 135696|UX CTMS 360|CTMS - Study Manager - Monitoring]
Add Monitoring Transitions to define the steps that will be used in the workflow through the Monitoring Report Transitions
Add Monitoring Report Workflow Transition [Ticket 135697|UX CTMS 360|CTMS - Study Manager - Monitoring]
Add Monitoring Report Workflow Transitions to define the order and properties that will be used in the workflow through the Monitoring Report Workflow
Monitoring Template Manager [Ticket 135708|UX CTMS 360|CTMS - Study Manager - Monitoring]
The Monitoring Template Manager allows the user to define the templates that will be used to report monitoring activities for the studies.
Monitoring Template Name Screen [Ticket 135709|UX CTMS 360|CTMS - Study Manager - Monitoring]
The Add Monitoring Template form allows the identification and classification of the template that is being added.
Monitoring Template Form Screen [Ticket 135710|UX CTMS 360|CTMS - Study Manager - Monitoring]
The Edit Monitoring Template Configuration form allows users the ability to add questions, change the order of questions and update existing questions to the monitoring template.
Monitoring Template – Add Field [Ticket 135711|UX CTMS 360|CTMS - Study Manager - Monitoring]
A Monitoring Template can have configurable fields added to the template.
Monitoring Template – Add Connection Field [Ticket 135712|UX CTMS 360|CTMS - Study Manager - Monitoring]
A Monitoring Template can have connection fields, that connects with UX EDC or UX CTMS study fields and populates data, added to the template.
Site Monitoring Visits Form [Ticket 135713|UX CTMS 360|CTMS - Study Manager - Monitoring]
The monitoring reports for each study site is managed through the Site Visits Form
Monitoring Report Transitions [Ticket 135714|UX CTMS 360|CTMS - Study Manager - Monitoring]
The Monitoring Report Transitions move the report through the study defined workflow.
Add Monitoring Report [Ticket 135717|UX CTMS 360|CTMS - Study Manager - Monitoring]
A Monitoring Report can be added through the Site Visits screen.
Monitoring Plans Navigation [Ticket 135718|UX CTMS 360|CTMS - Study Manager - Monitoring]
Monitoring Plans contain a sub-menu for navigation.
Monitoring Visits Form [Ticket 135719|UX CTMS 360|CTMS - Study Manager - Monitoring]
The study monitoring template plans are managed through the Monitoring Visits form.
Add Monitoring Visit Frequency [Ticket 135721|UX CTMS 360|CTMS - Study Manager - Monitoring]
Monitoring Visit Frequency can be added to the Monitoring Visit Plan form.
Monitoring Visit Plan Form [Ticket 135722|UX CTMS 360|CTMS - Study Manager - Monitoring]
The plans for when monitoring visits will occur at the study site is managed through the Monitoring Visit Plan form.
Monitoring Visit Workflow Plan [Ticket 135725|UX CTMS 360|CTMS - Study Manager - Monitoring]
The Monitoring Visit Workflow Plan for a study is assigned on the Add Study form.
Activate Monitoring Plan Template [Ticket 145107|UX CTMS 360|CTMS - Study Manager - Monitoring]
The Monitoring Report Templates are Activated in the Monitoring Template Manager.
Monitoring Report Workflow Screen [Ticket 150301|UX CTMS 360|CTMS - Study Manager - Monitoring]
A Monitoring Report Workflow defines the steps that a monitoring report will go through during review and finalization.
Monitoring Template Form Move Questions [Ticket 171872|UX CTMS 360|CTMS - Study Manager - Monitoring]
A Monitoring Template allows for question order to be moved.
Site Monitoring Visit Form with Name of Visit Field [Ticket 176220|UX CTMS 360|CTMS - Study Manager - Monitoring]
The Site Visits form contains by default the Name of Monitoring Visit Field.
Alerts Manager
For UX CTMS Alerts Manager, we have included the nine (9) items outlined below:
Alerts Manager [Ticket 135632|UX CTMS 360|CTMS - Alerts Manager]
The Alerts Manager provides an overview of alerts generated within the system.
Duplicate Product Alert [Ticket 135633|UX CTMS 360|CTMS - Alerts Manager]
Alert checks will fire when a Duplicate Product is entered.
Duplicate Site Alert [Ticket 135634|UX CTMS 360|CTMS - Alerts Manager]
Alert checks will fire when a Duplicate Site is entered.
Duplicate Vendor Alert [Ticket 135635|UX CTMS 360|CTMS - Alerts Manager]
Alert checks will fire when a Duplicate Vendor is entered.
Duplicate Personnel Alert [Ticket 135636|UX CTMS 360|CTMS - Alerts Manager]
Alert checks will fire when a Duplicate Personnel is entered.
Duplicate Study Alert [Ticket 135637|UX CTMS 360|CTMS - Alerts Manager]
Alert checks will fire when a Duplicate Study is entered.
Duplicate Regulatory Body Alert [Ticket 135652|UX CTMS 360|CTMS - Alerts Manager]
Alert checks will fire when a Duplicate Regulatory Body is entered.
Alert Fires for Future Date [Ticket 137546|UX CTMS 360|CTMS - Alerts Manager]
Alerts will fire when Standard Edit Checks are defined as No Future Date for dates and the date is a future date.
Alert Fires when Not Answered [Ticket 150310|UX CTMS 360|CTMS - Alerts Manager]
Alerts will fire when Standard Edit Checks are defined as Preferred Entry or Required Entry and the question is not answered.
Reports Manager
For UX CTMS Reports Manager, we have included the forty-eight (48) items outlined below:
CTMS Site Contracts Report [Ticket 132828|UX CTMS 360|CTMS - Reports]
The Site Contracts Report provides a table for each Site Contract defined for a study.
CTMS Study Budgeting Report [Ticket 135663|UX CTMS 360|CTMS - Reports]
The Study Budget Report provides the budgets defined for the Study Budgets, Site Budgets, and Vendor Budgets on the Study Budgets screen for each study.
CTMS Patient Report [Ticket 135704|UX CTMS 360|CTMS - Reports]
The Patient Report displays the questions defined for each patient at each study site.
Ad-Hoc Report Screen [Ticket 138338|UX CTMS 360|CTMS - Ad-Hoc Reports]
Ad-Hoc Reports allow the creation of reports on UX CTMS data.
Create Ad-Hoc report Select Table Screen [Ticket 138339|UX CTMS 360|CTMS - Ad-Hoc Reports]
A dataset table must be selected to Create Reports.
View Report Fields Screen [Ticket 138340|UX CTMS 360|CTMS - Ad-Hoc Reports]
Fields found on the dataset table can be selected to be included in an ad-hoc report.
Modify Ad-Hoc Report Field Name [Ticket 138341|UX CTMS 360|CTMS - Ad-Hoc Reports]
Ad-Hoc report fields can be modified.
Create Report Formula Fields [Ticket 138342|UX CTMS 360|CTMS - Ad-Hoc Reports]
Formula Fields can be created for ad-hoc reports.
View Properties Screen for Report Type [Ticket 138344|UX CTMS 360|CTMS - Ad-Hoc Reports]
With Report Properties, reports can be configured to filter or sort data.
Generate Report Output [Ticket 138345|UX CTMS 360|CTMS - Ad-Hoc Reports]
Ad-Hoc reports can be displayed in several different Output formats.
Create/Edit Report Screen [Ticket 138348|UX CTMS 360|CTMS - Ad-Hoc Reports]
Ad-Hoc Reports can be created and edited.
View Contents Screen for Package Report [Ticket 138353|UX CTMS 360|CTMS - Ad-Hoc Reports]
Ad-Hoc Report Packages can be created to combine reports into one output.
Delete Report Fields [Ticket 139906|UX CTMS 360|CTMS - Ad-Hoc Reports]
Ad-Hoc fields can be deleted from reports.
Create/Edit Filter [Ticket 139914|UX CTMS 360|CTMS - Ad-Hoc Reports]
Filters can be applied to ad-hoc reports through report Properties.
Delete Filter [Ticket 139915|UX CTMS 360|CTMS - Ad-Hoc Reports]
Filters can be removed from ad-hoc reports.
Create/Edit Sort [Ticket 139917|UX CTMS 360|CTMS - Ad-Hoc Reports]
Sorts can be applied to ad-hoc reports through report Properties.
Delete Sort [Ticket 139918|UX CTMS 360|CTMS - Ad-Hoc Reports]
Sorts can be removed from ad-hoc reports.
Edit Output Settings (Package Report) [Ticket 139925|UX CTMS 360|CTMS - Ad-Hoc Reports]
Ad-Hoc Report Packages output can be edited.
Edit Output Setting (Report Type) [Ticket 139927|UX CTMS 360|CTMS - Ad-Hoc Reports]
Report Output setting can be edited.
CTMS Regulatory Submissions Status Report [Ticket 140409|UX CTMS 360|CTMS - Reports]
The Submission Status report provides a table for each submission or amendment defined at a study.
CTMS Report Manager Listing [Ticket 141635|UX CTMS 360|CTMS - Reports]
CTMS Standard and Ad-Hoc reports are listed in a sub-menu.
CTMS Patient Visit Schedule Report [Ticket 141636|UX CTMS 360|CTMS - Reports]
The Patient Visit Schedule report displays a visit schedule for patients with the expected versus actual visit dates.
CTMS Enrollment Report [Ticket 141637|UX CTMS 360|CTMS - Reports]
The Enrollment Report shows an overview of the Study Enrollment based on Patient Status, breaks down the enrollment at a site level based on Site Enrollment and provides a timeline report for enrollment numbers for each study.
CTMS Feasibility Report [Ticket 141638|UX CTMS 360|CTMS - Reports]
The Feasibility Report displays the Site Feasibility results for each study.
CTMS Contact List Report [Ticket 141639|UX CTMS 360|CTMS - Reports]
The Contact List report shows the contact information for personnel assigned at the Study, Vendor, and Site level, along with a Site Contact list.
CTMS Deviation Trends Report [Ticket 141640|UX CTMS 360|CTMS - Reports]
The Deviation Trends report shows the Study Deviation status at an enterprise or study level.
CTMS Milestone Gantt Chart [Ticket 141641|UX CTMS 360|CTMS - Reports]
The Milestone Gantt Chart provides an overview of milestones as a project management chart.
CTMS Milestone Summary Report [Ticket 141642|UX CTMS 360|CTMS - Reports]
The Milestone Summary report provides a summary of enterprise and study level milestones.
CTMS Study Milestone Report [Ticket 141643|UX CTMS 360|CTMS - Reports]
The Study Milestone Metrics report displays a summary of milestones at the study and site level for each study.
CTMS Study Status Report [Ticket 141644|UX CTMS 360|CTMS - Reports]
The Study Status shows an overview of the Study Setup status for each study.
CTMS Site Status Report [Ticket 142238|UX CTMS 360|CTMS - Reports]
The Site Status report shows an overview of the Site Setup status for each study.
CTMS Monitoring Visit Schedule Report [Ticket 142242|UX CTMS 360|CTMS - Reports]
The Monitoring Visit Schedule report displays a schedule for monitoring visits with the expected versus actual visit dates.
CTMS Monitoring Status Report [Ticket 142244|UX CTMS 360|CTMS - Reports]
The Monitoring Status report shows an overview of the monitoring status for each study.
CTMS Site Metric Report [Ticket 142246|UX CTMS 360|CTMS - Reports]
The Site Metrics report displays metrics on a sites performance within UX EDC.
CTMS Vendor Cost Report [Ticket 142248|UX CTMS 360|CTMS - Reports]
The Vendor Cost report provides the total costs for all vendors at a study level.
CTMS Regulatory Submission Details Report [Ticket 142249|UX CTMS 360|CTMS - Reports]
The Submission Details report shows the status of regulatory submissions and provide an overview of the requirements for each submission.
CSV and Excel Exports for CTMS Reports [Ticket 142256|UX CTMS 360|CTMS - Reports]
Standard reports provide the ability to export results in CSV and Excel formats.
Canvas Menu for CTMS Reports [Ticket 142257|UX CTMS 360|CTMS - Reports]
Standard reports can contain a canvas menu to manage view of results.
Framework for CTMS Ad-Hoc Report [Ticket 142284|UX CTMS 360|CTMS - Ad-Hoc Reports]
CTMS Ad-Hoc Reports can be executed on configurable forms.
Generate SQL Queries for Ad-Hoc Reports [Ticket 142534|UX CTMS 360|CTMS - Ad-Hoc Reports]
CTMS Ad-Hoc Reports provide data based on the report configuration.
Missing Data Type in Ad-Hoc Report [Ticket 150314|UX CTMS 360|CTMS - Ad-Hoc Reports]
CTMS Ad-Hoc Reports will display the Missing Data Type selected for blank questions.
Graphs for Reports [Ticket 153068|UX CTMS 360|CTMS - Reports]
Standard and Ad-Hoc reports provide output in graph format.
Delete Ad-Hoc Report [Ticket 174951|UX CTMS 360|CTMS - Ad-Hoc Reports]
CTMS Ad-Hoc Reports can be deleted.
Ad-Hoc Report Function Help [Ticket 174962|UX CTMS 360|CTMS - Ad-Hoc Reports]
The Formula Fields screen provides help text for functions.
Milestone Gantt Chart to Include Dependencies [Ticket 175280|UX CTMS 360|CTMS - Reports]
The Milestone Gantt Chart visually displays dependent milestones.
Monitoring Status Report contains Monitoring Status and Averages Report [Ticket 176423|UX CTMS 360|CTMS - Reports]
The Monitoring Status report contains the Monitoring Status Report and Monitoring Averages Report.
Study Enrollment Timeline [Ticket 176492|UX CTMS 360|CTMS - Reports]
The Enrollment Report contains an enrollment timeline report.
Milestone Performance Report [Ticket 177522|UX CTMS 360|CTMS - Reports]
The Milestone Performance report displays a summary of the expected versus actual duration between milestones at the study and site level for each study.
Audits
For UX CTMS Audits, we have included the twenty-two (22) items outlined below:
Compare Difference between CTMS Versions [Ticket 62066|UX CTMS 360|CTMS - Audits]
The Compare Versions provides the ability to view the differences between one UX CTMS Settings version and another.
Record Audits for CTMS [Ticket 62098|UX CTMS 360|CTMS - Audits]
Audit trials will be recorded for CTMS activities.
Form Audits [Ticket 62099|UX CTMS 360|CTMS - Audits]
Form Audits are recorded when actions take place on a CTMS form.
Question Audits [Ticket 62100|UX CTMS 360|CTMS - Audits]
Question Audits are recorded every time a change is made to a question on a CTMS forms, including the initial data entry.
Form Audits Manager [Ticket 62101|UX CTMS 360|CTMS - Audits]
The Form Audits Manager displays all form audits.
Question Audits Manager [Ticket 62102|UX CTMS 360|CTMS - Audits]
The Question Audits Manager displays all question audits.
Audits Manager Menu [Ticket 118547|UX CTMS 360|CTMS - Audits]
A sub-menu displays all Audit Managers.
CTMS Reason for Change [Ticket 142535|UX CTMS 360|CTMS - Audits]
A Reason for Change is collected when data is changed on a question, based on the UX CTMS Setting Audit Reason for Change Requirements for Data Changes setting.
Study Milestone Builder Audit [Ticket 142536|UX CTMS 360|CTMS - Audits]
Audits are stored for Study Milestones.
Monitoring Template Version Manager [Ticket 145108|UX CTMS 360|CTMS - Audits]
The Monitoring Template Manager allows the ability to view the differences between one Monitoring Template version and another.
Monitoring Version Difference [Ticket 145109|UX CTMS 360|CTMS - Audits]
The Monitoring Version Difference displays the differences between one Monitoring Template version and another.
CTMS User Access History [Ticket 145110|UX CTMS 360|CTMS - Audits]
CTMS access history is tracked in Enterprise Manager.
Visit Data Version Manager [Ticket 145112|UX CTMS 360|CTMS - Study Manager - Plans]
The Visit Schedule allows the ability to view the differences between one Visit Schedule version and another.
Visit Data Comparing Versions [Ticket 145113|UX CTMS 360|CTMS - Audits]
The Visit Schedule displays the differences between on Visit Schedule version and another.
Warning for Reason for Change [Ticket 171741|UX CTMS 360|CTMS - Audits]
A warning will display on the screen when a Reason for Change is needed and the user tries to navigate off the form.
Monitor Report/Study Deviation Workflow Audits [Ticket 176424|UX CTMS 360|CTMS - Audits]
Transition Audits are recorded for all Monitoring Reports and Deviation transition steps.
Workflow Transition Audit Manager [Ticket 176425|UX CTMS 360|CTMS - Audits]
Transition Audits Manager displays all transition audits.
Regulatory Submission Status Audits [Ticket 176426|UX CTMS 360|CTMS - Audits]
Regulatory Submission Audits are recorded when regulatory submission statuses are applied by a user on the Mange Submissions Screen.
Regulatory Submission Audits Manager [Ticket 176427|UX CTMS 360|CTMS - Audits]
Regulatory Submission Audits Manager displays all submission audits.
Payment Status Audit Manager [Ticket 176428|UX CTMS 360|CTMS - Audits]
Payment Status Audits are recorded for all payment activity in the Site Payments and Site Payment Approvals Managers and displayed in the Payment Status Audits Manager.
Audits and Reason for Change on Regulatory Requirements [Ticket 176429|UX CTMS 360|CTMS - Audits]
Audits and Reason for Change will be collected on the regulatory requirements screen.
CTMS Reason for Change List [Ticket 177367|UX CTMS 360|CTMS - Audits]
Reason for Change options are managed through a Managed List.
Import Manager
For UX CTMS Import Manager, we have included the seven (7) items outlined below:
Patient Import [Ticket 135705|UX CTMS 360|CTMS - Imports]
Patient information can be imported through the Imports Manager.
Imports Manager [Ticket 140177|UX CTMS 360|CTMS - Imports]
Imports into CTMS forms are performed in the Imports Manager.
Product Import [Ticket 140178|UX CTMS 360|CTMS - Imports]
Product information can be imported through the Imports Manager.
Site Import [Ticket 140179|UX CTMS 360|CTMS - Imports]
Site information can be imported through the Imports Manager.
Vendor Import [Ticket 140180|UX CTMS 360|CTMS - Imports]
Vendor information can be imported through the Imports Manager.
Personnel Import [Ticket 140181|UX CTMS 360|CTMS - Imports]
Personnel information can be imported through the Imports Manager.
Deviation Import [Ticket 140182|UX CTMS 360|CTMS - Imports]
Deviation information can be imported through the Imports Manager.
Roles and Permissions
For UX CTMS Roles and Permissions, we have included the thirty-seven (37) items outlined below:
Configure Unrestricted Roles [Ticket 122300|UX CTMS 360|CTMS - Roles and Permissions]
Unrestricted Roles can be configured in UX CTMS Setting through Configuring Roles.
Configure Restricted Roles [Ticket 122301|UX CTMS 360|CTMS - Roles and Permissions]
Restricted Roles can be configured in UX CTMS Setting through Configuring Roles.
Delete Entities [Ticket 122302|UX CTMS 360|CTMS - Roles and Permissions]
Entities can be deleted in UX CTMS Setting through Configuring Entities.
Define User Access Entity [Ticket 122303|UX CTMS 360|CTMS - Roles and Permissions]
Entities can be defined for user access in UX CTMS Setting through Configuring Entities.
User Administration Screen [Ticket 122306|UX CTMS 360|CTMS - Roles and Permissions]
User Administration is managed within UX CTMS.
Add UX CTMS User [Ticket 122307|UX CTMS 360|CTMS - Roles and Permissions]
Users can be added to UX CTMS through the User Administration screen.
Edit UX CTMS User Access [Ticket 122310|UX CTMS 360|CTMS - Roles and Permissions]
UX CTMS user access can be edited through the User Administration screen.
Remove UX CTMS User Access [Ticket 122311|UX CTMS 360|CTMS - Roles and Permissions]
UX CTMS user access can be removed through the User Administration screen.
Configure Study Specific Roles [Ticket 140211|UX CTMS 360|CTMS - Roles and Permissions]
Study level access can be defined through the User Administration screen.
Permission checks for User Admin [Ticket 145627|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for User Administration.
Permission checks for Site Screens/Actions [Ticket 145629|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Site screens and actions.
Permission checks for Vendor Screens/Actions [Ticket 145630|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Vendor screens and actions.
Permission checks for Personnel Screens/Actions [Ticket 145631|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Personnel screens and actions.
Permission checks for Payment Screens/Actions [Ticket 145632|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Payment screens and actions.
Permission checks for Regulatory Manager Screens/Actions [Ticket 145634|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Regulatory Manager screens and actions.
Permission checks for Audits Manager Screens/Actions [Ticket 145637|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Audits Manager screens and actions.
Permission checks for Alerts Manager Screens/Actions [Ticket 145638|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Alerts Manager screens and actions.
Permission checks for Imports Screens/Actions [Ticket 145639|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Imports screens and actions.
Permission checks for Reports Screens/Actions [Ticket 145640|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Reports screens and actions.
Permission checks for Monitoring Configuration Screens/Actions [Ticket 145641|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Monitoring Configuration screens and actions.
Permission checks for Ad-Hoc Reports Screens/Actions [Ticket 145643|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Ad-Hoc Reports screens and actions.
Permission checks for Study Specific Study Form Screens/Actions [Ticket 145644|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Study Form screens and actions.
Permission checks for Study Specific Clinical Plans Screens/Actions [Ticket 145645|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Clinical Plans screens and actions.
Permission checks for Study Specific Milestone Configurator Screens/Actions [Ticket 145646|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Milestone Configurator screens and actions.
Permission checks for Study Specific Study Budgets Screens/Actions [Ticket 145647|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Study Budgets screens and actions.
Permission checks for Study Specific Regulatory Collection Screens/Actions [Ticket 145648|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Regulatory Collection screens and actions.
Permission checks for Study Specific Regulatory Configuration Screens/Actions [Ticket 145649|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Regulatory Configuration screens and actions.
Permission checks for Study Specific Site Level Screens/Actions [Ticket 145652|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Site Level screens and actions.
Permission checks for Study Specific Vendors Screens/Actions [Ticket 145655|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Vendors screens and actions.
Permission checks for Study Specific Monitoring Reports Screens/Actions [Ticket 145656|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Monitoring Reports screens and actions.
Permission checks for Study Specific Deviations Screens/Actions [Ticket 145657|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Deviations screens and actions.
Permission checks for UX CTMS Settings [Ticket 150274|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for UX CTMS Settings screens and actions on the approve server.
Access CTMS through Desktop [Ticket 153279|UX CTMS 360|CTMS - Roles and Permissions]
Ability to access the CTMS tool through the Desktop.
Permission checks for Study Specific Milestone Collection Screens/Actions [Ticket 166076|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Study Specific Milestone Collection screens and actions.
Permission checks for Unrestricted Role Milestone Screens/Actions [Ticket 166233|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Milestone screens and actions for Unrestricted Roles.
Permission checks for Products Screens/Actions [Ticket 168337|UX CTMS 360|CTMS - Roles and Permissions]
Permission checks are implemented for Products screens and actions.
Study Personnel added to Default Roles [Ticket 177180|UX CTMS 360|CTMS - Roles and Permissions]
The permissions for study personnel will be configured for default roles.
CTMS General
For general UX CTMS items, we have included the thirty-six (36) items outlined below:
Add CTMS Tools [Ticket 62063|UX CTMS 360|CTMS]
A CTMS tool can be added to a workgroup in Enterprise Manager, one tool per workgroup can be added.
CTMS Admin Role [Ticket 122299|UX CTMS 360|CTMS]
A CTMS tool contains an Admin role in Enterprise Manager that grants the user access to UX CTMS Settings and full access to all CTMS forms and screens.
Multi Document Field [Ticket 132831|UX CTMS 360|CTMS - Study Manager - Plans]
A Multi Document Field allows multiple documents to be uploaded to forms.
Dropdown Select Field [Ticket 134084|UX CTMS 360|CTMS]
A dropdown select field is an answer option for forms.
Date Fields [Ticket 134082|UX CTMS 360|CTMS - Vendor Manager - Contracts]
Date and Partial Date questions appear on forms.
Manager & Dashboard Navigation Menu [Ticket 135631|UX CTMS 360|CTMS]
A menu will display the managers and homepage to navigation through UX CTMS.
CTMS File Manager [Ticket 135655|UX CTMS 360|CTMS]
Files uploaded in CTMS appear in the CTMS Folder in File Manager.
Profile displays languages with native localization [Ticket 136483|UX CTMS 360|User Interface]
The options for selecting the language in the profile will use the languages own localization.
CTMS System Forced to English [Ticket 137238|UX CTMS 360|CTMS]
The CTMS system will use English even if the user has selected non-English in profile.
General Navigation Tree for CTMS [Ticket 137240|UX CTMS 360|CTMS]
A sub-menu will display for screens and forms with hierarchical forms.
Filter for Reference Type Question [Ticket 137744|UX CTMS 360|CTMS]
Filter options exist in managers for the reference type questions.
User Interface Adjustments [Ticket 139604|UX CTMS 360|User Interface]
User interface adjustments were made to DATATRAK ONE.
Default Values for Questions [Ticket 139841|UX CTMS 360|CTMS]
Default values can be set by default for questions on CTMS forms.
No Version Warning Screen [Ticket 139853|UX CTMS 360|CTMS]
When a CTMS tool does not contain a published version the production tool will display a warning.
CTMS Dashboard [Ticket 140155|UX CTMS 360|CTMS - Desktop Widgets]
The CTMS Homepage is a dashboard for viewing specific data based on the user’s role.
Calendar Widget [Ticket 140157|UX CTMS 360|CTMS - Desktop Widgets]
The CTMS Homepage contains a Calendar Widget.
Checklist Widget [Ticket 140158|UX CTMS 360|CTMS - Desktop Widgets]
The CTMS Homepage contains a Checklist Widget.
Delete Checklist [Ticket 140159|UX CTMS 360|CTMS - Desktop Widgets]
Checklist can be deleted from the CTMS Homepage.
Widget Configuration [Ticket 140163|UX CTMS 360|CTMS - Desktop Widgets]
The Widget Configuration allows a user to configure what widgets will display on the user’s homepage upon entry into CTMS.
Delete CTMS Forms [Ticket 141626|UX CTMS 360|CTMS]
CTMS forms can be deleted.
Display Deleted CTMS Forms [Ticket 141627|UX CTMS 360|CTMS]
Deleted CTMS forms can be displayed.
Delete CTMS Study [Ticket 141628|UX CTMS 360|CTMS]
Studies can be deleted in the Studies Manager.
Common Date Class for CTMS [Ticket 146100|UX CTMS 360|CTMS]
Date format classes are not dependent on external data format.
Deleted Questions and Managed List [Ticket 150265|UX CTMS 360|CTMS]
Question or managed list options added on approve can be deleted until the questions and managed list options are published to production.
Questions and Managed List Options Appear based on Visibility Settings [Ticket 150688|UX CTMS 360|CTMS]
Questions and managed list options appear on the screen based on their Visibility Setting.
Save and Cancel Form Buttons [Ticket 153105|UX CTMS 360|CTMS]
UX CTMS forms contain Save and Cancel buttons.
File Properties for CTMS Files [Ticket 162413|UX CTMS 360|CTMS]
File Properties defined for workgroups apply to CTMS files.
Session Timeout Notice [Ticket 168386|UX CTMS 360|CTMS]
Session timeout notice will display when inactivity occurs in UX CTMS.
Question Type to Accept Large Characters [Ticket 169893|UX CTMS 360|Systems]
Question type added to CTMS to accept large characters for certain connection fields on monitoring templates.
Handling of AJAX Request [Ticket 169928|UX CTMS 360|CTMS]
Requests are processed for CTMS through AJAX.
Summary Table with Export [Ticket 172335|UX CTMS 360|CTMS]
Table reports provide a summary dataset in the export.
Questions are Plain-Text when Read Only [Ticket 172346|UX CTMS 360|CTMS]
Questions display as plain text when the form is read only.
Save Search in CTMS Manager [Ticket 172561|UX CTMS 360|CTMS]
CTMS Managers allow Saving a Search.
Actual Field in Site Enrollment Optional [Ticket 175767|UX CTMS 360|CTMS]
The Actual field on the Site Enrollment screen contains an optional entry edit check.
Reports Widgets [Ticket 176247|UX CTMS 360|CTMS]
The CTMS Homepage contains widgets for Standard Reports and Ad-Hoc Reports.
Immutable Questions Preferred [Ticket 177639|UX CTMS 360|CTMS]
The immutable questions on CTMS forms have by default preferred edit checks unless specified.
Enhancements (Non-CTMS)
For 14.0.0, we have included seven (7) enhancements:
Reinforce Date and Time Based Format Checks [Ticket 122474|UX EDC & Medical Coding|Data Architect]
Date Format checks expanded to fire alerts if date and time formats do not match the format provided, and removing the need to write format edit checks for date and times.
Update UARF Template [Ticket 122526|DATATRAK ONE|Enterprise Manager]
Updated the UARF template to clarify required elements and add additional information as well as modifying the formatting. The new template is downloaded from within Enterprise Manager in place of the old template.
View User Detail Screen Scheduler Access [Ticket 134623|DATATRAK ONE|Enterprise Manager]
Scheduler Access details are added to the View User Detail Screen in Enterprise Manager.
Reason for Change added to Form and Subject Audit Manager [Ticket 162430|UX EDC & Medical Coding|Managers]
The Reason for Change column is added to the Form and Subject Audit Managers.
Standardize Edit Checks – Blank Edit Checks [Ticket 164299|UX EDC & Medical Coding|Data Architect]
Designers now have the ability to define a question as requiring or optionally requiring an answer without the creation of edit checks, through the Blank Edit Check attribute.
Increase Initial File Manager Available Size [Ticket 166291|DATATRAK ONE|File Manager]
The initial available size in the File Manager is increased to 1GB per study.
Expiration Dates Should Not Show in Audit Trial [Ticket 169814|UX RTSM|Trial Supply Management]
The Inventory Container Manager audits will only contain the expiration date when the role has the View Blind permission.
Corrections
For 14.0.0, we have included the three (3) correction items outlined below:
Product Type Column Multiple Choice Filter. [Ticket 175065|UX EDC & Medical Coding|Cross Study Managers]
The Product column in Cross Study Managers will now allow selection of more than one product at once.
Tabular View Layout [Ticket 176011|UX EDC & Medical Coding|Data Entry & Cleaning]
The Tabular View Layout is updated when show hidden questions and designer info without large form distortion.
Viewing Queries from the Workflow [Ticket 177544|UX EDC & Medical Coding|Collaboration]
Query Workflow is updated to prevent an error from displaying when viewing queries.
Maintenance
For 14.0.0, we have included seven (7) maintenance items:
Property Files [Ticket 151139|DATATRAK ONE|Systems]
Added a new test automation server to the staging environment.
Manager Metadata Progress Bar Display Issue [Ticket 166518|UX EDC & Medical Coding|Managers]
Manager Metadata Progress Bars are displayed corrected in the Microsoft Edge browser.
Property Files [Ticket 172100|DATATRAK ONE|Systems]
Added new staging servers.
Virtual Cluster Simulation [Ticket 175437|UX CTMS 360|CTMS]
Virtual cluster simulation for UX CTMS added to staging environments.
Property Files [Ticket 175448|DATATRAK ONE|Systems]
Added sales server to property files.
Remove Check for Classic UI Desktop [Ticket 177731|DATATRAK ONE|Systems]
Removed unnecessary check on Desktop for the Classic User Interface.
Property Files [Ticket 177827|DATATRAK ONE|Systems]
Added Ops Approve server to property files.
Outstanding Issues
Custom export crashes if a formtype is mapped to more than one dataset and the the formtypeID ends with an integer
If a formTypeID ends with an integer and the form type is mapped to more than one dataset in a custom export, the export will not complete.
Double data entry: Basic parameters do not list the Frozen Status restriction
If a double data entry difference report is restricted by the Frozen Status, the restriction is not included in the Basic Parameters for the results.
Entering dates in the wrong format in the EM Search Tools screen generates an error
When the user enters a date by hand in the search tools instead of using the datepicker, an error is displayed.
Today Option on Date Calendar on Confirm Shipments Does not Work
On the Confirm Shipment screen, when the date calendar pop up appears, the ‘Today’ button does not work. If you select it, nothing happens. This option should populate today’s date like it does in the eCRF.
Loading of properties can cause null pointer exceptions when using character set restrictions
Very rarely, checking character set restrictions may cause an error to be displayed to the user.
“Attach” button for the ‘singleDocument ‘ or the ‘multiDocument’ questions stops working if “Upload” action performed first
For singleDocument or multiDocument questions, the user is unable to attach a document after the upload action is performed.
Back button after sorting doesn’t work
In the file manager sub folders, when the user clicks the back button, the user receives a confirm resubmission page instead of the previous page.
Basic Setup in Visual Architect Library Panel does not have “Overwrite Design” option
If you go to the Visual Architect, load library, and right click on the Basic Setup node in the Library pane, the “Overwrite Design” option should be displayed.
Translation in the actions menu are not generated properly
In header menu there is an instance where there are 2 keys separated by a space. In some languages this may not be appropriate.
Function ‘Length’ of Ad-hoc report does not work properly
In Ad-hoc Reports, a zero length string is considered null and will make the Length function not work properly.
Poor performance in tabular view for the Unified UI
When viewing a form in Tabular View, if the add form button is repeatedly clicked, the system may become slow or unresponsive.
EULA Modification of Chinese Taiwan shows English in preview
If the user is editing the EULA and clicks a preview for Chinese (Taiwan) EULA, the english version will be displayed instead of the Chinese (Taiwan) one.
Dependency variable evaluation can fail depending on date format
It is possible for dependencies with date calculations to work with certain date formats and fail with others.
Characters not displaying properly in SAS database due to utf-8 encoding
In the SAS database, some characters may not be displayed due to the utf-8 encoding.
Form Flow Transition page is not refreshed correctly when the form is locked
When the user attempts to use form flow transitions with locked forms, the user may receive an error.
“IsUniqueWithinDynamicForms” dependency allows to restore the role with the same name
It is possible to create two roles with the same name by creating the role, deleting it, creating it again and then restoring the deleted role.
“Email Subject” issue for inventory transfer email
When the Email Subject for the inventory transfer email references the [toolID] and the shipment for a child site is initiated from the All Sites node, the Tool ID in the email subject is reported for the All Sites node rather than the destination site.
Billing Report tables expand to incorrect width
When viewing a billing report with at least one facet, expanding and minimizing tables can cause the width of the table to expand until it is no longer completely visible.
When the user expands tables repeatedly. The tables may slowly expand until they are not usable.
Several places missing horizontal scroll bar for the small screens
When the user views the system on a small screen, there are some places in the system that will not have a scroll bar. This issue appears in the contacts, enterprise manager, and uCTMS reports.
Announcements will have delay before being synced
If an announcement is updated, a user on a different cluster may still view the old announcement for some time before it gets updated.
PDF Export of Deleted Subjects With Same Subject ID Should Produce Appended File
If two or more deleted subjects have the same primary record ID, only the casebook of the one with the lowest primary record ID is exported.
Managers screens jump left
If the user scrolls to the very right of a scroll bar in a manager and then changes the sorting order on the filter, the screen will jump left in some browsers.
UX RTSM Reports > Shipment Summary report > Shipment Counts – does not display ‘Shipments Partially at Destination’.
Partial shipments are not displayed in the shipment summary table count and pie chart.
In Zoom mode extra button click is required to get back to container
If the study is configured with useSavePrompt set to ‘yes’ and saveOnExit set to ‘no’, when the user navigates to a dynamic form in the tabular view, fills the form out and clicks the back button, the dialog asking if the user wants to leave the page is displayed twice.
Issues related to the ‘enterKeyAction’ configuration
For some browsers, enterKeyAction does not work to go to the next field properly when the enterKeyAction is set to nextField. In other situations when enterKeyAction is submitted, the form is not submitted properly with certain browsers.
Some characters cause errors in Visual Architect
Some characters can be entered into a DA which will not allow the file to be opened in VA and will display an error to the user.
Only 1 instance of EM tool should be created
When a sub client is configured on a stand alone server and not a cluster, the Enterprise manager is created 4 times.
notSet Missing Data Flag is saved as red alert
If notSet flag is set in the DA and a question has a red alert, it will be saved as red alert with no reason for override instead of open without reason or closed without reason.
Dynamic formIds are incremented
When the user copies and pastes a dynamic form into visual architect, the formid is incremented. All dynamic forms of the same formTypeId should have the same formId.
Email Notification cause import to fail
Under the following conditions an error can occur during import:
- updateQueryWhenValueChange=answered
- updateQueryWhenValueChangedByImport=true
- “Query Answered” notification set up at the “Query Manager” location
‘Paste Item’ in Visual Architect does not work until you publish or commit trial
In Visual Architect, if the user attempts to paste an item in a tab other than the casebook tab, the paste item will not work until the trial has been published or committed.
VA delete does not work in IE
In Internet Explorer if the user attempts to delete a VA item using the delete key, there may not be a confirm deletion dialog and the item will not be deleted.
In VA, dropdown menu stays in place on browser resize
In VA, if a browser is resized on the properties page while a dropdown menu is open, the menu will not adjust to the new location. It should adjust location along with the rest of the elements on the page.
Dropdown lists move when highlighted in VA
If the user is using Internet Explorer, the items in a VA dropdown list may shift unexpectedly.
Resolved values in the expression language are parsed and interpreted
Resolved variables in the expression language are further interpreted by the expression language. For example, if a data value of a question is 5<6, the value will be resolved to true instead of ’5<6′.
When the toolname is numeric only it drops leading zeros
The scripting language drops leading zeros for a toolname that is completely numeric.
Improve Scatter Chart
For scatter plots, it is possible that the scale of the chart is incorrect and will cut the point in half.
Property commands are not processed upon reconcile
The setProperty command will not be reconciled even if shouldReconcile is “true”. For incrementProperty, if target is set to “before” is not executed correctly. In following script only the first command will be executed. If target is set to “after” all commands will be executed upon reconcile.
Patient wasn’t reported missing in Difference Report
In some cases the Difference Manager does not report all missing patients.
Do Not Write Branching To XML If Forward To Is Empty
If the forward to is empty, the branching XML is still published.
createForm command issue
Forms may have duplicate sequence ids if createform with sequence is used and the forms are added under a container on a remote server.
Role names containing non-ASCII characters can cause display errors
If role sets contain non ascii characters and the encoding is not utf-8, the name of the roles may be displayed incorrectly in Enterprise Manager.
Remove Randomization permission defaults from dataArchitect template
When a DA is decompiled, the randomization permissions are enabled by default. For trials without randomization they have to be deleted and added back if randomization is configured later.
Secure the user interface to not allow adding invalid chars
If the user copies characters from a different application, these characters may be invalid and stored as a special error character.
Cannot Cleanly Increase Block Sizes
When a randomization schedule needs to be amended, it is not possible to increase the block size without creating a partial block. If this is done, the treatment ratios may also not be correct.
Freeze scripts are not shown in form debug page
If the user is accessing the form debug page, freeze scripts will not be displayed.
Total time spent for a parent activity not calculated correctly sometimes
Training time calculation is sometimes not accurate for parent activities. The time should be the sum of all the child activities but sometimes the values do not add up correctly.
With large Case Books sequencing of forms is out of order in some cases
When a very large casebook is created, the order of the forms may not be according to the sequence numbers.
Audit Manager Export issues
If the user views an audit type of Audit Object in Japanese, it will not be translated.
Managers can display an error if the same filter is applied to same manager on different servers simultaneously
If the user has the same manager open in two browsers, each pointing to a different server, and the user runs a filter in both browsers for that manager, one of the managers will display an error.
Nested functions do not parse correctly
If there is a formula with a nested function, the result may be inaccurate.
DA: Remove Visit Schedule granted permission
The DA Template has permission granted for the visit schedule by default which usually will need to be changed by the designer
Add the Shared Inventory ID to the DA
Randomization supports multiple sites sharing inventory, but there is not a place to specify it in the DA
Alert script commands will trigger text commands to work at the wrong time in some cases
A script will fire alert only if both questions are not blank if any of the questions is blank the alert should be removed. A null pointer is generated in some cases.
Audits of type OLD are still being written
There are still a few places in the system where audit types can be created that have a type of OLD.
Activation receipts for blinded fields are not generated in RM
If a user without ‘viewBlind’ permission activates a subject, the blinded fields are not generated and users with the ‘viewBlind’ permission will be unable to review the blinded fields and activation status.
Restriction on Start and End Levels should work in Search Results
When searching for codes, if non-standard start and end export levels have been specified in the study configuration, only those levels should appear in the search.
Actions can be submitted twice on some randomization actions
Across the randomization actions, it is possible to click submit or populate buttons repeatedly. This can cause actions to be executed twice in quick succession
Ad-hoc Reports: contact control should resolve to user name
Sometimes Ad-hoc Reports will return the id of a user rather than the username for a contact control.
Problems if two users commit VA at the same time
If two users commit to a VA file at the same time from different servers one of the user’s changes will be lost.
‘Is Default’ can be answered ‘Yes’ for multiple portals
In Management Servlet, it is possible for there to be more than one default portal and the order of returned default portals is not consistent.
OC4J holds onto message classes used with JGroups
The wrong class can be used during redeployment for JGroups messages.
If one of design server is down, it still publishes DA file
If a user attempts to publish a DA file while a design server is down, it still publishes the DA file to the other design server. It should not publish to the other server if either server is down.
Management Tool entries are incorrect
In management servlet if the search filter is changed to address only, the entries in the dropdown menu are not correct.>
Report creation does not present wizard screen for permissions
When using the creation wizard for Ad-Hoc Reports, it is possible for the Permission screen to not appear if certain fields are modified during report creation. The workaround is to access the screen through the “Permission” link rather than through the wizard.
Exporting auto code variables in all caps does not work
When an export is configured with the parameter columnUpperCase, auto coded variables and non-question columns do not export in all caps as desired.
In Contact Manager if the page is not saved after adding files, the files may not be added
If the user adds a file in contacts but does not save the page, the item will not be attached.
Closing folders upon clicking another link (not keeping the sort)
From the calendar day view, if the user has a filter applied and then clicks on a different day, the filters are forgotten.
Text can be cleared when the “Enter” key is hit while adding a calendar event
If the user hits the “Enter” key when adding a calendar event, it clears the text and does not submit the form.
Some numeric comparisons need to be surrounded by quotes in order for them to work in edit checks
When an edit check is created without quotes, in some cases it will not fire. This only exists for the greater than and less than comparators and “0″.
Locked questions should have disabled checkboxes in the Alerts and Codes Managers
If a question is locked, the checkbox should be disabled in the Alerts and Codes Managers. It’s disabled in the Query Manager but not in the Alerts and Codes Managers.
When browser’s “Back” button is clicked the Files tree doesn’t respond
In File Manager when the user clicks the browser’s Back button, the Files Tree does not update to show the user’s new location in the Files Tree. It is recommended that the user not use the browser’s Back button when using File Manager.
Approved shared files are stored in wrong folders or get lost
When the user has a sharing request for the same document from multiple workgroups for which the user is an administrator or contributor, if the user clicks the share request from the Desktop and approves the request on the following screen, the file can get lost or be stored in the wrong folder. To work around this, administrators or contributors can approve the share request by navigating to File Manager and accessing the share request from there.
Shipment Origin filter should display all packaging location and all sites regardless of viewGlobalShipments permission
Currently in Cross Study Manager for a User with no viewGlobalShipments permission, the Shipment Origin filter displays all packaging locations and only the site the user has access to. However the records for the other sites are displayed in the table, because only Shipment Destination filter should restrict to the current site. Shipment Origin filter should display all packaging location and all sites regardless of viewGlobalShipments permission
Shipment filters should display sites within scope of the bridge
When two bridges are configured for randomization, the origin and destination filters in the Cross Study Shipments Manager show sites from the second bridge when the user doesn’t have access to those sites. The records that belong to sites from the second bridge are not displayed, which is correct functionality.
Override Reason filter sorting does not work properly
If you create alerts with override reasons ND, NK, NA and other letters, the applied sorting is not properly applied.
In Synonym Manager, synonym sorting should ignore the case
Currently when sorting is applied to the Synonym column in Synonym Manager, synonyms with capital letters come before those with lower case letters. Sorting should ignore the case.
Some symbols do not render correctly in the Manage Notifications feature
In the Manage Notifications feature, the Email Subject column for saved notifications displays the greater-than sign as “>” and the lesser-than sign as “<”.
If you add more than 100 fields to a Graph Ad-Hoc report and run the report output, an error displays.
If you add more than 100 fields to an Ad-Hoc report and select any graph report output, an error displays.
Navigation within the Desktop Calendar sometimes resets entries.
If a user adds two trials at the same time to the Desktop Calendar, navigates to one of the trial’s sites, the other trial is deleted from the Calendar upon return to the Desktop.
Similar trial names with different characters will sometimes have duplicate configuration paths
If two trials are enrolled with names that are differentiated only by special characters, the trials will have the same configuration path (i.e. test0101, test0101_).
Import File Name could cause Missing information on import history screen
If an import file name contains a “_”, on import history screen, the imported file, imported by and import file size information will be missing.
Typo in Portal Descriptor
There is a typo in the Portal Descriptor that has an incorrect field name as a result. This triggers an exception in some cases but it is in an area of code that should never be called.
Blank Screen in Trial Manager when Switching Roles After Actions are Performed
If a user performs an action in Trial Manager and then switched to a role that does not have permission to the performed action a blank screen is displayed.
The calendar pop-up box is not displayed after RFO audit icon clicked
If a user opens the Reason For Override Audit screen and the closes the screen and selects a date field the Calendar Pop-up box does not display.
drugAssign command fails to update frozen question with overrideFreeze=”true”
The drugAssign assignment does not update a frozen question when overrideFreeze=”true” is set.
Alerts > 14 Days counts doesn’t show correct value in Cross Trial Summary Report.
Cross Trial Summary Report in Trial Manager does not show correct value for Alerts greater than 14 days.
“Needs SDV” and “Needs Data Review ” counts show incorrect values for Cross Trial Summary report
Cross Trial Summary Report in Trial Manager does not show correct values Form Level Needs SDV and Needs Data Review.
Adding letter to the Drug Container ID gives clickOS error for Populate Inventory action
A ClickOS error occurs upon Populate Inventory Action if a Container ID is updated to include a letter through the Drug Container Manager.
Files with apostrophe sign (‘) in the name cannot be uploaded, Forbidden screen is displayed
A Forbidden error screen appears upon upload of a file with apostrophe sign (‘) in the file name.
It is possible to have Received, Missing, Broken boxes checked for the same row in Confirm Shipment screen
A user can select the “All” Boxes on the Confirm shipment screen and the system does not uncheck any previously checked boxes.
Calendar Sharing Event Details screen has the same fields for different type events
When viewing calendar event details for shared events the screen does not display all event fields for the different type of calendar events.
View Tasks screen sorting does not work when New Task screen is cancelled
When you hit Cancel from the New Task screen, upon selecting any header to sort tasks the New Task screen will be displayed.
Using Browser Back Button from Course History and selecting Reset or Search gives a ClickOS error
A ClickOS error occurs upon selecting Reset or Search buttons on the Manage Courses screen after returning from the Course History page using browser back button.
Blank Course Equivalency dialog pops up
A Course Equivalency dialog appears blank if a Course Equivalency is removed from the course on another server.
View Log screen does not have DATATRAK footer
The View Log screen in Enterprise Manager for Training Courses does not contain the DATATRAK footer.
The Find textbox in the Training screen does not show [Letter]* when the user clicks the Find button
The user Training Screen does not populate the Find textbox when a letter is selected.
“Select Options” text is displayed truncated
Select Options text is truncated on the New Shared Set Dialog and Add Shared Standard Set Dialog in UX CTMS.
Permission Denied Dialog truncates error response
When the user has Roles.ActionsRequired.uploadDocument but does not have Roles.ScreenRequired.uploadDocuments the the Permission Denied Dialog truncates the error message when the Upload File button is clicked.
DA Compiler does not generate errors, when invalid record status dependencies are added
When an invalid record status dependencies path is compiled an error is not displayed.
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