Frequently Asked Questions

What is a Clinical Trials Management System (CTMS)?

The CTMS is an online tool for managing all aspects of the clinical-trial lifecycle. This includes study participant and safety management, and electronic data capture and reporting through its core module.

  • Study initiation

  • Study identification
  • Proposal development*
  • Confidentiality Agreement (CDA)
  • Coverage Analysis
  • Budget
  • Ancillary services
  • Time and effort planning
  • Budget negotiations with sponsor
  • Clinical Trial Agreement (CTA)
  • Institutional Review Board Coordination (IRB)
  • Study account(s) creation and setup
  • Sponsor invoicing
  • Regulatory Documents
  • Study activation
  • Finance Management

  • Effort tracking
  • Clinical trials billing
  • Charge Master
  • Research Orders
  • Charge reconciliation
  • Charge capture/entry
  • Sponsor invoicing and A/R management
  • Study management

  • Informed consent
  • Subject recruitment
  • Subject enrollment
  • Subject scheduling
  • Biospecimen management**
  • Inventory / storage management**
  • Requisition and distribution management**
  • Data management
  • Case report form (CRF)*
  • Reportable events
  • Significant new information/findings (SNIF)
  • Protocol amendments
  • Study reporting
  • Audit and Monitoring
  • Study close out

  • Initiate study close out
  • Account reconciliation
  • Inactivate award account(s) in financial system
  • Maintain and submit technical reports to sponsor
  • Post-trial Audit / monitoring

* Phase 2

** Optional Modules

For a detailed roadmap of CTMS plans and feature availability see CTMS Roadmap

What are the benefits of using the CTMS?

  • Consistently capture and track protocol, study, administrative, and financial data needed for management of trials
  • Added transparency between study and finance teams to track study activities and payment
  • Reduce multiple isolated, informal environments for managing and tracking study data
  • Eliminate redundant/multiple software infrastructures
  • Reduce costs to manage clinical research within individual units
  • Increase the capability to provide meaningful reports and data regarding the financial status of a study to Principal Investigators
  • Improve regulatory compliance
  • Central repository for study-related information (budgeting, patient tracking, care reports) and a catalogue for materials stored in biorepositories

Who benefits from using the CTMS?

Researchers

  • A Principal Investigator Console displays information pertinent to PIs, including accrual and protocol status
  • Access to reports on accrual, financial status, subject safety and more
  • Review and capture subject safety information consistently across studies
  • Secures research data and allows audit logging of data modifications
  • Supports study participant recruitment through a public Web
  • Provides integrated biospecimen management for studies with sample collection (not part of initial roll out)
  • Stores and provides access to patient registry data (not part of initial roll out)

Research Staff

  • Web accessibility to protocol and subject information, including consent forms, visit schedule and electronic case report forms
  • Integrations with other enterprise-wide systems lead to reduced duplicate data entry and increased data quality
  • Automated email notifications to support communication and efficient workflows, such as, including IRB expiration alerts, IRB notifications, protocol and subject status
  • Provides a calendar view of when your research participants are scheduled for visits
  • Access can be limited to approved consent forms
  • Additional recruitment capabilities through public display of study information

Administrative Directors

  • Access to key reports on financials, cycle times, staff workload and other key metrics
  • Better understand your clinical trial research portfolio
  • Ensure standard procedures are being followed consistently
  • Provide the use of a single tool to adhere to a well-defined set of common processes
  • Allows trends and opportunities for improvement to be identified through metrics tracking and reporting

Regulatory Administrators

  • Tracks submissions, communications and actions for various regulatory bodies including scientific review committees, FDA, IRB and data safety monitoring committees
  • Generates automated notification alerts prior to IRB expiration
  • Generates automated notifications to inform the research team of key status changes as you enter regulatory tracking information

Finance Staff

  • Links study procedures to a single rate list provided by our primary clinical providers and labs
  • Provides financial projections for sponsor billing based on the linked study calendar and negotiated study budget
  • Offers an accurate and timely view of what items are ready to be invoiced to a sponsor
  • Tracks invoices and receivables

The Public

  • Added support for obtaining research results faster
  • Provides a searchable view of accurate and up-to-date open study information by you or your care provider via the Web

In what cases can I use the CTMS for my clinical trials?

If your trial involves billable services (i.e. requires Medicare Coverage Analysis) at Keck Medicine or CHLA. Examples of billable services include:

  • Labs that are processed by the clinical system, including labs that are drawn in research facilities and processed by the hospital
  • Procedures administered by hospital staff that are not part of usual care (example MRI or CT Scan)
  • Dispensing fees

If you are unsure if a Medicare Coverage Analysis is required for your study, the Clinical Trials Unit (Keck), Clinical Investigator Support Office (Norris Cancer Center), Clinical Research Support Office (CHLA) can help you determine if your study should use CTMS.

How can I or my research team become a CTMS user?

Any investigator conducting industry or non-industry clinical research trials contracted through University of Southern California (including Children’s Hospital of Los Angeles) is preapproved to utilize the system. To sign up for an account or request training, please email OnCoreSupport@med.usc.edu.

Are there any costs associated with using the CTMS?

No. The CTMS is viewed as a common-good enterprise system at USC, CHLA, and the Los Angeles County’s Department of Health Services.

Will the CTMS replace existing systems at USC and CHLA?

At USC, the CTMS is further planned to be integrated with the iSTAR (IRB system) and Cerner (PowerTrials) electronic health record systems. Additional integrations are being reviewed including the Kuali Financial System and PeopleSoft (CHLA). Studies utilizing the CTMS will be exempt from tracking in True2, True, and Iris.

Once data go into the CTMS, can they be extracted? If so, how?

OnCore’s base system includes standard reports that are accessible to users in order track and maintain all components of clinical trial management. The base system also comes with DT4 Tables for Cancer Center reporting. USC has the ability to provide custom reports that are developed from our clinical research informatics team as requested. Trials utilizing electronic data capture within the CTMS are also able to export all EDC data needed for analysis in SAS or excel formats.

Is “Enterprise OnCore” different from the “OnCore CTMS” system used by some cancer centers in the United States?

Yes. In addition to providing biospecimen and registry management modules, the core Enterprise OnCore component for clinical-trial management was enhanced by the vendor beyond what was developed for cancer centers to allow each specialty to have a uniquely configured “library” and its own workflows. This enhancement allows multiple specialties to utilize the same system across the institution.