Summary

This article covers the 1.0.0 uCTMS Release notes. 

Table of Contents

Welcome to the uCTMS 1.0.0 Major Release!

uCTMS 1.0.1

  • 21780: Drug Packaging should have multi-select for sites to be supplied
  • 21809: uCTMS 1.0.1 Release Notes

uCTMS 1.0.0

The 1.0.0 Major Release contains the initial version of the uCTMS product. The features included in this release are as follows:

20665 – uCTMS 1.0.0


20942: Visit Summary

Create a Visit Summary Report.

20951: Schedule of Events

Create a Schedule of Events Report.

20966: Create Study Design Visit Forms When Design Summary Is Completed

The value recorded in the Total Number of Visits (designTotalVisits) question should be used to create a set of dynamic subforms (designVisit) to represent each of the visits recorded as the Total Number of Visits.

20620: Create a Stand Alone CTMS Product

Create a standalone CTMS product while maintaining a framework supportive of future versions of the product that can be integrated with non-Datatrak products.

20945: Vendor Summary

Create a Vendor Summary Report.

20974: Create a set of standard reports for CTMS

Create a set of standard reports to support the uCTMS product.

20975: Create a high level dashboard for CTMS

A link from the TM homepage will bring the user to the CTMS standard reports page.

21021: Custom casebook calculations

All monthly summary information should roll up to the site summary and the site summaries should roll up to the study planning summary for enrollment data where applicable. The section under the planning summary should have no manual data entry.

21048: Add summary details to forms to provide further instructions to users

Add instructions to form summaries where there are dynamic forms so the users have a clear indication of how to interact with and use the system to enter their data.

21055: Fix homepage to allow inclusion of datagenie reports

Allow reports listed onthe study homepage to be listed dynamically.

21067: Hide Hourly Rate questions per role

Create role based restriction to hourly rate fields.

21124: Expense Costs Report

Create an Expense Costs Report.

21240: Create a high level dashboard for the Trial Level

Each trial in the uCTMS reporting area should have an overall summary.

21244: Create timeline for the study level summary

Create a timeline that will be added to the ctmsTrialSummary.

21263: All extJS tables that have large amounts of data must have exports

All report data should be exportable.

20935: Site Summary

Create a Site Summary Report.

20957: Create a report for managing differences between sites

The production node in TM will house most of the sites associated with the clinical trial. These sites will also be created in CTMS. A report is needed to verify that there are no differences between the two sets of sites. We also need to create an export of the CTMS sites as well as modifying the import for the TM Production sites.

20928: Hide reports from sibling tools

Reports within DataGenie in the Trial Manager/CTMS product must be from either ancestor tools, the existing tool, or child tools. Reports created by sibling tools must be hidden. The tool where the report is created from should be recorded as part of the report creation.

20929: Modify form view types to allow form hiding

The following form view types must be modified to support the hiding of forms in the summary and the form links tree. formPartialEdit, formEdit, formRestrictEdit, formView.

A link needs to be added (conditionally) to the homeRight.jsp file of Trial Manager for CTMS users to gain access to the reporting area. This link is depending on their being records within the current tool network that have CTMS enabled.

20931: Create a reports page for listing out all CTMS reports

The link from the TM homepage will bring the user to this page. It must have a filter area that includes the list of CTMS records in the TM. Once a record is selected, the filter must remain and the page should refresh with all applicable reports linked to with that record id. The reports will need to be categorized and some roles will not have access to all of the reports (to be defined).

20934: Team Summary

Create the Team Summary Report.

The ability to add dynamic forms should be restricted based on the form type and user role.

Hide the links to add dynamic forms on the Vendor Summary in formSummary.jsp.

21065: Export/Import modifications for transferring sites between uCTMS and uDesign

From the uCTMS site section, we need to generate a CSV export that can be used to create sites under the uDesign Production node

21117: Vendor Costs Report

Create a Vendor Costs Report.

21127: Labor Costs Report

Create a Labor Costs Report.

21129: Team Rates Summary

Create Team Rates Summary Report based on the Team Summary Report.

21209: Create Ability To Suppress Dynamic Form Summaries In Export

Create a configurable parameter/property which can be used to suppress the export of dynamic form summaries when dynamic child form is present and is not blank.

21210: Restrict Export Content to uCTMS Trials

The uCTMS export(s) should only include data for trials that have the uCTMS product enabled.

20937: Protocol Deviations

Create a Protocol Deviations Report.

20939: Subject Enrollment Report

Create a Subject Enrollment Report.

20940: Subject Summary Report

Create a Subject Summary Report.

20949: Serious Adverse Events

Create a Serious Adverse Events Report.

21120: Site Costs Report

Create a Site Costs Report.

20621: Create Framework to Support Unification of eClinical Data/Information

Create a framework to support reporting of study status data and metrics that are drawn directly from unified DATATRAK products (uEDC, uIRT, uDesign, etc.).

20622: Create a ‘Study’ Section

Create a ‘Study’ section of the uCTMS tool which can be used to register studies, capture and identify key study information and track study level approvals.

20623: Create a ‘Planning’ Subsection

Create a ‘Planning’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture project management information and study planning milestones.

20624: Create a ‘Monitoring’ Subsection

Create a ‘Monitoring’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture data supporting the monitoring plan, activities and budget for the study. The information recorded should include key monitoring metrics.

20625: Create a ‘Data Management’ Subsection

Create a ‘Data Management’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture and track data supporting the data management plan, activities and budget for the study. The information recorded should include key data management metrics.

20626: Create a ‘Sites’ Subsection

Create a ‘Sites’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture relevant site specific information. The information recorded should support tracking and managing site contact information, study related documents, key site personel, site visit information, contract, invoice and payment related information.

20627: Create a ‘Vendors’ Subsection

Create a ‘Vendors’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture and manage relevant vendor management related data. Information recorded should support tracking and managing of vendor contact information, study responsabilities, contract, invoice and payment related information.

20628: Create a Cost/Payment Management Subsection

Create a ‘Cost’/’Payment Management’ subsection of the CTMS tool’s ‘Study’ section which will be used to capture data and manage study cost related information. Information recorded should support tracking and managing of study budgets including study personel, site costs, vendor costs, etc.

20954: Create new CTMS roles in Trial Manager

Create uCTMS specific roles to support use of the uCTMS product.

20956: Questions need to be restricted to specific roles

The questions within the new forms must be restricted by role using the formPartialEdit/formRestrictEdit viewType.

21114: Create a ‘Documents’ Subsection

Create a ‘Documents’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture data supporting the review and approval of documents for the study.

21115: Create a ‘Protocol Deviations’ Subsection

Create a ‘Protocol Deviations’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture data supporting the documentation and tracking of protocol deviations for the study.

21116: Create a ‘Serious Adverse Events’ Subsection

Create a ‘Serious Adverse Events’ subsection of the uCTMS tool’s ‘Study’ section which can be used to capture data supporting the documentation and tracking of serious adverse events through the course of the study.

21119: Support Creation of Vendor Type Specific Vendor Forms

Create a function to support the creation of vendor service type specific vendor forms so that the questions on the form can be targeted toward the service provided.

21122: Support Copying Of Site Address To Pharmacy Address When Applicable

Support the ability to copy the following site address values to the pharmacy address fields on the Site Form.

21123: Support the Controlled Generation of the uCTMS and uDesign Products

Create a trigger to support the controlled generation of the uCTMS product.

21221: Create uCTMS Mapped Export

Create a mapped export to support extracting data from the uCTMS product. The export should group similar formTypes into single data sets. The format should be MS Excel.

21458: Create a ‘Project Team’ Subsection

Create a ‘Project Team’ subsection of the uCTMS tool’s ‘Study’ section
which can be used to support recording members of the project team that are not specifically working on Data Management or Monitoring.

21196: Add tips for reference questions

Add tips associated with reference questions to identify answer option sources.

Outstanding Issues

  • There are no outstanding issues at this time.



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