Central Study Registration and scientific review are mandatory as of November 13, 2017

The UB Clinical Research Office announced that effective Monday, November 13, 2017, two new initiatives to facilitate and support clinical research across UB will be initiated: Central Study Registration (CSR) and Department/School Scientific Review. 

CSR will institute the initial single point of entry for the various processes, workflows and software platforms for clinical research at UB. The data required for several systems, once entered into the Central Study Registration Form, will flow to each system that requires the information:

• Click Agreements
• Click Safety
• Click IRB
• OnCore Clinical Trials Management System
• Clinical Research Management System (CRMS)
• Electronic Sponsored Projects routing form

Central Study Registration (CSR) and Department/School Scientific Review will be mandatory for:

• All clinical research (see definition below) originating within the health sciences schools:
  • Jacobs School of Medicine and Biomedical Sciences
  • School of Nursing
  • School of Dental Medicine
  • School of Public Health and Health Professions
  • School of Pharmacy and Pharmaceutical Sciences
• Department of Biomedical Engineering
• Campus-wide for all clinical trials (see definition below)

The website for Central Study Registration is https://www.research.buffalo.edu/studyregistration.

Central Study Registration will be required prior to submitting your study to the IRB.  Please note the following exceptions where Central Study Registration and Scientific Review do not apply:

• If you are submitting your protocol to the IRB for determination of 'Not Human Subjects Research' 
• If you are seeking 'Exempt Status' from the IRB for your study
• If your research is originating from a non-health science school at UB and is not a clinical trial
• If your research does not meet the definition of clinical research and does not require IRB submission

Please note that Central Study Registration can be initiated at any point once you have decided to pursue the clinical research project.  

• Early submission is encouraged for the reasons detailed below. 
• Central Study Registration shall precede the submission of the study for IRB consideration in Click. Required documents can be added at any stage.
• Central Study Registration is not retroactive. Clinical research studies already approved do not need to be entered.​

When investigators (or their team members) respond to questions within the CSR form, they will receive detailed information and links to information, forms and policies that are required to conduct research at UB and through our hospital affiliates.

Departmental/School Scientific Review will be initiated via Central Study Registration by the Clinical Research Office, and the process has been fully integrated into the Central Study Registration process.

The Clinical Research Office has extensively tested the registration process with end-users across UB and you will find it to be simple and short. Training on the system is available on a daily basis.  

Associate Director of the Clinical Research Office Kim Brunton is managing this initiative and is in charge of training. She can be reached at kbrunton@buffalo.edu or at 888-4840. 

Please do not hesitate to reach out to Kim or Director of the Clinical Research Office Sanjay Sethi, MD, at ssethi@buffalo.edu or 888-4864 with any questions or concerns.  

Anticipated Benefits of CSR 

The CSR form serves to identify services and streamline the processes required to reduce redundancy in our current systems and to streamline the initiation and implementation of clinical research at UB. CSR will:

1. Provide early identification of current, new or changing university requirements needed for individual research studies to enable rapid, parallel completion of such requirements,
2. Provide links and contacts for many of the resources UB has to offer the investigator and his/her staff for the successful initiation and completion of the study,
3. Initiate the Departmental/School Scientific Review Process before submission to the IRB, which is considered best practice nationally at all leading research universities,
4. Reduce redundant data entry currently required to get the same information into multiple software systems for some studies,
5. Provide consistent data entry into each of the systems,
6. Provide robust reporting for UB’s leadership, department chairs and deans, and hospital affiliate institutions about ongoing research within their facilities, and
7. Initiate the routing for the Sponsor Approval Form early to facilitate research accounts establishment.

NIH Definition of Clinical Research

Patient-oriented research, including:

• Research* conducted with human subjects* (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts* with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes:

1.  Mechanisms of human disease, 
2. Therapeutic interventions, 
3. Clinical trials, or
4. Development of new technologies.

• Epidemiologic and behavioral studies
• Outcomes research and health services research

NIH Definition of Clinical Trials

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. 

*The terms “research,” “human subjects” and “interacts” are defined in section 46.102 of the Federal Policy for the Protection of Human Subjects ('Common Rule').