Research Roundtable: ‘I Want to Initiate a Human Subjects Research Project — Now What?’
Published September 10, 2021
In this first edition of the University at Buffalo Clinical and Translational Science Institute (CTSI) Translational Spotlight newsletter’s “Research Roundtable” section, UB's Clinical Research Office (CRO) looks behind the curtain of the Central Study Registration (CSR) system and Click modules to outline what happens after you submit your study to the CSR and subsequently through Click’s Institutional Review Board (IRB) system. The IRB component will be detailed in the next edition of “Research Roundtable.”
All studies conducted through one of the health sciences schools must register each of their studies through the CSR system. Only clinical trials (by NIH definition) conducted through the other schools on campus must register their studies. This should be done before any entry into the Click system, as CSR processing will begin the Click IRB entry.
What happens after you register your study may be a bit of a mystery until you get word that you are able to proceed. Here, we will explain what happens along the way once you submit your study to the registration system. In the next edition of “Research Roundtable,” we will explore how studies are categorized, look at the preliminary review process, and examine how studies are sent through for the appropriate approval mechanism within the IRB.
Click on each step in the flow diagram drop-down below for a description of what happens at that stage.
Submission Flow: Central Study Registration (CSR) to Institutional Review Board (IRB)
Once you have a research proposal or protocol in hand with a decision to move ahead with the project, the study must be entered into Central Study Registration (CSR) if it meets the requirements for registration.
Each of the health sciences schools must register their human subjects research studies, including chart reviews, at this time. Human research being conducted at any of the other schools at UB need only register their study if it meets the NIH definition of a clinical trial.
The CSR system is an initial point of entry for the various processes, workflows, and software platforms for those investigators conducting clinical research at the university. The Central Study Registration Form (CSRF) will capture information that is required for several systems that we are currently using at the university. Data entered into the CSRF will flow to each system that requires the information, including:
- Click Portal — IRB Module
- Click Portal — Agreements Module
- Click Portal — Safety Module
- OnCore Enterprise Research System
- Clinical Research Management System (CRMS)
- Click Portal — Grants Module (taking the place of the Electronic Approvals Form)
Investigators and their study team will receive detailed information based on a number of questions within the form that will link them to materials, forms, and policies that are required to conduct research at UB and through our hospital affiliates.
Who Must Register Their Studies?
Each of the health sciences schools must register their human subjects research studies, including chart reviews, at this time. Human research being conducted at any of the other schools at UB need only register their study if it meets the NIH definition of a clinical trial.
Status of Studies Within the System
When you enter a study in the system, it will appear under the “Pending” tab. While in a pending state, you may edit the entry or save if only partially completed until you are ready to submit the study. Once submitted, you can no longer edit the entry.
Who Can See the Entry?
Only the person named as PI and the people under “Study Contact” at the top of the form will be able to see the form in their list when they sign into the system.
To register your study, log in to the CSR system with your UBIT name.
Once a study has been submitted to the registration system, one of the CSR reviewers will “pick up” the study for review and processing. Generally, CRO Associate Operational Director Kimberly Brunton RN, MSN (kbrunton@buffalo.edu) handles funded studies, and CTSI Clinical Research Facilitators Alexis O’Brien (ahazard@buffalo.edu) and Jennifer Delmerico (jlgraf@buffalo.edu) process unfunded studies.
Scientific review is done at the departmental level.
There are several types of studies that the CSR processor will be able to complete, as it was deemed that sufficient review for the scientific merit of the study had been sufficiently established. These include industry, NIH/federal, or other funding agencies that have a robust peer review process and chart reviews.
In addition, student research projects that have been approved by a formal advisory committee (thesis or dissertation), or student projects that have accompanying documentation of review by a faculty advisor or documentation that the department has already completed a review, will not be sent for review.
All studies that do not meet one of the criteria mentioned above will be sent to the departmental representative for scientific review of the protocol. The CSR processor cannot move the study along in the process until the scientific review has been completed by one of the mechanisms noted.
Your Click IRB submission will be started based on the information you provide in the CSR form.
Ideally, you should enter the information into CSR before you complete supplemental forms the IRB will require (HIPAA waiver, final consent, recruitment materials, data collection sheets, etc.). This will allow you to work on these items while the preliminary work is done for the IRB submission (and any other services that you may request/require).
If you are utilizing an external IRB for the oversite of your study (commercial), the appropriate paperwork (reliance agreement and HRP 907, if applicable) will be started for you. The HRP 907 will be sent to you for PI signature, and the reliance agreement will be filled in with the study information on the commercial IRB’s template and submitted for UB signature. Both of these documents will be uploaded in the preliminary IRB Click entry. You will retrieve the partially executed reliance agreement from Click IRB to be sent to the commercial IRB for their signature and upload the fully executed document when you upload the approved documentation from the IRB of record.
In the case of another institution acting as IRB of record, CSR processing will contact the compliance officer in the IRB to establish how to proceed (Smart IRB or other).
DO NOT enter study information into CSR and then begin your own submission in Click IRB, as this will result in a duplicate study entry.
If you entered your study into Click IRB before you submitted your study into CSR, you will be provided instructions from the IRB coordinator as to how to proceed. You do not need to void the submission you began, but you will have to provide the IRB study number associated with your study in the CSR form where indicated.
The information you provide within the CSR form will allow the contract for the study to be submitted to the Click Agreements Module for you. DO NOT enter your contract into the system yourself. (There are several people that the CSR processing administrator must include in the submission so the proper system notifications are provided and downstream processes can occur. Account establishment, OnCore, and invoicing are among these processes.) If in doubt, please reach out to kbrunton@buffalo.edu for guidance.
You will be provided system notifications as the contract progresses through the various stages of negotiation.
CSR processing will submit this on your behalf.
The Click Grants Module submission will also be completed for you for industry-sponsored studies based on the information you provide in the CSR form.
For industry-sponsored studies, the budget will be entered for the amount that is guaranteed as non-refundable start up. Typically, this is at least $5,000. Other non-refundable fees may be applicable.
However, the start up will only be reflected in the budget that is included with the entry submitted. This has been established as procedure with UB’s Sponsored Projects Services for industry-sponsored studies.
The Click Grants submission will result in a funding proposal being entered. A funding proposal is required for an account to be established for study funds (PTA number).
All in-patient and any IRB-approved studies enrolling participants at either Kaleida Health or Erie County Medical Center (ECMC) facilities are registered in this system. This is done to facilitate compliant research billing, which can be challenging when UB does not own the facility at which research procedures are being done.
The participant’s information is entered by the study staff to allow for our institutional partners to be notified the individual is in a clinical trial. This also allows for claims to be coded correctly for billing compliance and for invoicing for those research-related services. The appropriate parties are notified through the research office once the study staff enter the information. It is a federal mandate that NCT numbers appear on the claims that are submitted to third-party payers, including insurance companies and Medicare/Medicaid.
All budgets are reviewed by the Clinical Research Office prior to finalizing the contract in order to ensure our institutional fees are included and consistent. Entering the study in CSR also generates the protocol billing grid which can then be used to indicate items or services that may be billed to a third party (such as Medicare). The billing grid is required for every clinical trial based on Clinical Trial Policy.
Through the CSR system, you may also indicate if you would like the budget specialist to assist in the negotiation of your budget.
For federally funded clinical trials or other human subject trials for which Sponsored Projects Services is assisting with budget development, the CRO should be consulted to establish which institutional fees/costs will need to be included in your budget.
