Published November 1, 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:
Central Study Registration (CSR) and Department/School Scientific Review will be mandatory for:
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:
Please note that Central Study Registration can be initiated at any point once you have decided to pursue the clinical research project.
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 firstname.lastname@example.org or at 888-4840.
Please do not hesitate to reach out to Kim or Director of the Clinical Research Office Sanjay Sethi, MD, at email@example.com 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:
NIH Definition of Clinical Research
Patient-oriented research, including:
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').