Trial registration in CRMS/OnCore

OnCore is a Clinical Trial Management System (CTMS) purchased by the university as a central system for study management and the registration of all clinical trials being conducted through the university. Implementation is a phased-in process that began in summer 2016.

All research studies conducted at UB will be registered and managed within the CTMS. This allows us to identify the individual studies being conducted at the university and ensure compliance with local and federal regulations. It also offers an opportunity to to report on the university’s research portfolio, sharing information with individual investigators, department chairs, university leadership, our affiliate institutions and federal funding agencies (NIH-CTSA). All university departments, schools and investigators conducting clinical research activities are required to register their studies and manage their subject visits within the system.

The Clinical Research Management System (CRMS) is our current, home grown system that was a precursor to OnCore. Currently, there are five departments required to register all trials in the Clinical Research Management System (CRMS). They are: Cardiology; Infectious Diseases; Neurology; Orthopedics, and Vascular. Other departments are encouraged to use the system but are not mandated to do so. 

The OnCore CTMS Coordinator, Siobhan Brady, can answer any questions you have regarding the current CRMS or the ongoing OnCore implementation.

Siobhan Brady

• (716) 888-4713
• skbrady@buffalo.edu 

To begin registration into the CRMS, you will need to assemble the necessary documents for upload.

• Log onto the system and enter your login information.  
  • If you need login credentials please use the ‘Contact us’ link located at the bottom right of the sign in page to request an account.  
• Once in the system, you are asked for details about the study, the PI and coordinator and location of services. 
• You also will be required to upload the protocol (minimum) at this time.  
• You will need to upload the following documents when available and applicable:
  • Coverage analysis
  • Contract
  • Budget
  • FDA letters (IND/IDE) 
  • Any associated consent forms for the study  

When all final documents are uploaded, the CRO will open the study for enrollment within the system. Once open, you will need to have all subjects enrolled through the system to ensure that the study complies with billing guidelines.

While many studies are not concerned with billing compliance, they still must register within the system. However, they may be exempted from registering individual subjects. The CRO will make the decision on what's necessary.

*We will update instructions as necessary once the OnCore CTMS system is active across all UB schools and departments.

It will take 10-15 minutes to register your study and upload the necessary document in the current CRMS system.