Resource Center //
Training & Learning
A comprehensive collection of articles, manuals of procedures (MOPs), FAQs, training materials, and educational resources for investigators, study staff, and departments involved in clinical trials.
Clinical Trials Resources
The Clinical Study Registry (CSR) website is designed for investigators and study teams to register clinical trials, streamlining study initiation and building a comprehensive research database to support high-quality research at the University of Pittsburgh.
It serves as the primary point of interaction between study teams and the Clinical Trials Office (CTO) at the University of Pittsburgh. It plays a crucial role in the study initiation process by collecting essential information about all new protocols being proposed at the University. The data gathered through this platform is meticulously reviewed and analyzed by the CTO to determine the suitability and necessity of building a study within the OnCore Clinical Trial Management System (CTMS). This process ensures that the CTO is equipped with the necessary details to support the study team right from the early stages of study startup, providing a smooth and efficient transition into the setup phase.
In addition to facilitating the study startup process, the CSR website aims to develop a centralized database encompassing all research protocols conducted at the University of Pittsburgh, regardless of whether the CTO is directly involved in their management. This comprehensive database will offer a valuable resource for tracking and reporting on the full spectrum of research activities across the university, addressing a critical gap in information that previously existed. By having a more complete view of the research landscape, the CTO can better understand the needs of the study teams, streamline processes, and ensure compliance with university and regulatory requirements. Ultimately, the CSR website not only streamlines the study submission process but also supports the broader mission of fostering high-quality research at the University of Pittsburgh.
Clinical Research Applications
Reference links for Clinical Trials Research applications including OnCore CTMS, REDCap, and Clinical Trials Registration.
Clinical Trials Workflow Documents
Facilities and Other Resources
OnCore CTMS Resources
Request OnCore Access
A study team or department Authorized Requestor may submit the User Administration form for staff to gain OnCore access.
OnCore Overview
The OnCore Clinical Trial Management System (CTMS) is a comprehensive, enterprise-level software designed to streamline the management of clinical trials. It provides tools to efficiently track study progress, patient participation, regulatory requirements, and financials, ensuring compliance and enhancing operational efficiency across the research lifecycle. By centralizing critical trial data, OnCore enables improved oversight, transparency, and collaboration between research teams and support staff.
OnCore setup is currently underway, and the system is planned to be launched for selective departments at the University of Pittsburgh in early 2025. OnCore CTMS will integrate with Pitt’s current systems to ensure consistency and reduce duplication of effort. The system will also align with the existing OnCore CTMS in use by the Hillman Cancer Center.
The primary benefit of OnCore CTMS is that it serves as a single point of entry for multiple functions related to clinical trial management, including:
- Protocol management
- Enrollment tracking
- Safety monitoring
- Subject visit management
- Budgeting
- Invoicing
- Reporting
Using a centralized CTMS system will also streamline and standardize best practices in trial management. Study teams will be able to easily coordinate efforts and report results.
OnCore System Resources
OnCore Training Catalog
OnCore Training Prerequisites & Support
To ensure effective use of OnCore, all study teams and personnel involved in clinical research must complete a structured prerequisite training program before accessing the system. This training includes:
- Core System Overview: Introduction to OnCore’s key features and functionality, covering study setup, patient management, and reporting tools.
- Role-Based Training: Customized modules tailored to different roles, ensuring that users can efficiently perform their specific tasks within the system.
All users are required to complete prerequisite training before gaining access to the OnCore system. This training is essential to ensure that everyone is fully equipped to use the system based on their specific roles and permissions within a study or department.
To initiate the process, the study team or department must submit a User Access Form on behalf of the user. Once the form is submitted, the user will receive a link to sign into my.pitt.edu and access their training through the Canvas Learning Management System.
Upon completion of the training, users must respond to the email from the CTO Helpdesk to confirm their training is complete. This step ensures that the CTO Helpdesk can activate the appropriate OnCore permissions, allowing access to the system.