OnCore: Roles and Impacts - Who is Affected and How?

OnCore is a role-based system designed and managed to ensure data integrity, security, and compliance. This system assigns specific permissions to users based on their roles within the research and studies, allowing only authorized personnel to access, modify, or manage sensitive data. By regulating access according to predefined roles, the system maintains the highest standards of data protection and adherence to regulatory requirements, thereby safeguarding the confidentiality and accuracy of clinical trial information.

The OnCore system will impact individuals and teams involved in clinical research. The following is an overview of how different groups will be affected:

 

Principal Investigators (PIs):

  • PIs will have a centralized platform to manage and oversee their clinical trials, with access to comprehensive trial data and progress tracking capabilities.
  • They will be able to collaborate more effectively with study teams and monitor regulatory compliance more efficiently.

Study Coordinators:

  • Study coordinators will move their workflow to OnCore including subject data entry, subject tracking, and reporting.
  • Configurable notifications will bring specific study or subject milestones to their attention.  And task lists will help study coordinators organize their work with a checklist approach to their day-to-day tasks across all their studies.

Regulatory Staff:

  • OnCore's built-in compliance features, such as documentation storage, audit trails, and integration with CLICK, will facilitate regulatory compliance processes.
  • Regulatory staff will have better visibility into study documentation and be able to monitor compliance more effectively.
  • eReg, a separate module, will act as the electronic regulatory binder.
  • Sign-offs will be in place to prevent a study from opening to accrual unless regulatory staff has signed off that various aspects of the study start-up phase have been completed.

Coverage Analyst:

  • The Coverage Analyst will use Oncore to complete the QCT checklist and set billing designations for all calendar events on a study.  Like the work done by the budget analyst, this information will eventually create the billing grid that will flow downstream to Epic and facilitate an automatic routing of clinical charges.    

Study Site Contact:

  • Serves as the main communication liaison for a research site, coordinating interactions and logistics in the absence of a centralized study contact model.  Identified as the contact on the Advarra Site Information Portal (SIP) page in CTMS, and distinct from other roles due to their primary focus on site-level communication which includes research subject recruitment materials, referral forms, or links to external recruitment databases of resources.

Data Managers:

  • Data managers' processes will rely heavily on data integrity, the completeness and accuracy of data within OnCore, as their downstream work depends on the quality of the data entered by researchers.
  • Efficient data entry and setup by study teams will be crucial for data managers to perform their roles effectively.

Study Monitors:

  • OnCore will facilitate data monitoring reviews, data locks, query resolution, and data clean-up processes, helping to build and maintain data integrity throughout the study lifecycle.
  • Study monitors will have access to comprehensive study data and tools to streamline their monitoring activities.

Financial Teams:

  • These teams will be involved in various aspects of OnCore implementation, such as budgeting, resource tracking, and streamlining billing processes through integration with the other financial systems.
  • They will need to familiarize themselves with relevant OnCore functionalities and adapt their workflows accordingly. For example, the financial teams may need to utilize OnCore's Financial Console to manage budgets, track milestones, and generate invoices for sponsored studies.

Affiliate sites and Healthcare Partners:

  • Affiliate sites and Healthcare Partners will now have a central location to capture all information on their research participants and site activities.  Their access rights and permissions can be limited to see and do only activities they should be seeing and doing.


Staff roles drive system access rights that, in turn, drive training requirements.  The full list of staff roles and their definitions are as follows:

Principal Investigator The Principal Investigator is ultimately responsible for all aspects of the study.  Leads the research design and execution. Listed in protocol headers in CTMS, with visibility in the PI Console, differentiating them as the primary decision-maker and leader of the study.  Functionality of this role in system:  The staff member with Principal Investigator role is listed in the protocol header throughout OnCore. This code also determines which protocols a user with the PI Console permission can see in the PI Console.
Study Site Contact Serves as the main communication liaison for a research site, coordinating interactions and logistics in the absence of a centralized study contact model.  Functionality of this role in system:  Identified as the contact on the Site Information Portal (SIP) page in CTMS, distinct from other roles due to their primary focus on site-level communication.
Primary Research Coordinator Primary Research Coordinator.  Acts as the lead in monitoring compliance and data quality in clinical trials. In CTMS, appears as the Protocol Contact, emphasizing their role in overseeing trial conduct, distinct from coordinators due to their monitoring and audit focus.  Functionality of this role in system:  Staff assigned the CRA role appear in the subject header in Subject Console and in the Subject Console > Protocols > Subject Protocol table as the Protocol Contact.
Clinical Research Nurse Specializes in patient care, usually in dedicated clinical research settings, administering treatments and monitoring health.  Functionality of this role in system:  Determines the staff member listed as the Clinical Research Nurse in the Patient Interval Report.
Clinical Research Coordinator Manages day-to-day trial operations, including administrative tasks and data collection. Their role is central to patient scheduling and protocol adherence, distinct from CRAs who focus more on monitoring and compliance.  Functionality of this role in system:  Determines the staff member listed as the Clinical Trial Coordinator in the Patient Interval Report.
Clinical Research Nurse Coordinator Research nurse that specializes in patient care, usually in dedicated clinical research settings, administering treatments and monitoring health.  Also has study coordinator responsibilities.
Treating Physician Provides medical care to study participants, ensuring adherence to the treatment protocol. Identified in various forms in CTMS, distinct from nurses or coordinators due to their medical decision-making role.  Functionality of this role in system:  Staff with this role appear as Treating Physician in the Subject Registration Notice, Subject Search, and SAE form.
Regulatory Coordinator Manages the regulatory aspects of clinical research, ensuring compliance with laws, regulations, and guidelines. They prepare and submit necessary documentation to regulatory agencies.
Data Coordinator Manages the collection and entry of data in clinical trials. QA and operational, they ensure that data is accurately recorded and maintained in accordance with the protocol.
Data Manager Oversees the data management process, including data collection, validation, and analysis. They ensure the integrity and confidentiality of study data so accurate data can be extracted and valid/reproducible conclusions can be obtained.
Data Monitor Ensures the accuracy and completeness of clinical trial data through monitoring and auditing. They identify and resolve data discrepancies.
Financial Coordinator Manages the financial aspects of clinical research, including budgeting, billing, and financial reporting.
Laboratory Coordinator Oversees the laboratory components of clinical research, including sample collection, processing, and analysis.
Coverage Analyst Reviews clinical research protocols and related documents to determine insurance coverage and billing compliance for clinical trial participants.
Quality Assurance Focuses on ensuring that the clinical research is conducted and documented in compliance with quality standards, regulations, and protocols.
Sub-Investigator Assists the principal investigator in the scientific and technical aspects of the study. They often help with data collection and analysis.
Research Advanced Practice Professional A healthcare professional, often with an advanced degree, who participates in the clinical research process, possibly involving direct patient care or specialized assessments.
Co-Investigator Collaborates with the principal investigator in the design, conduct, and reporting of the research. They may share some responsibilities with the PI.
Study Activation Specialist Focuses on the initial set-up and activation of clinical trials, ensuring that all prerequisites for the start of the study are met.
Budget Analyst Responsible for the financial planning and analysis of research studies. They develop and monitor the study budget.