Guidelines for Using BRANY for NYU Clinical Trials

BRANY (Biomedical Research Alliance of New York) is an outsourcing agent for NYU SoM clinical trials. NYUSoM is part owner of BRANY and has an affiliation agreement allowing BRANY to be the IRB of record for NYU projects. The NYU SoM IRB automatically accepts BRANY IRB determinations. Some of the services rendered by BRANY include contracting and budgeting along with the regulatory administration as part of those processes.

 

Contracting Process for BRANY Projects

Certain multicenter clinical trial projects conducted at the School of Medicine may utilize the services provided by BRANY. For these projects, BRANY is responsible for the review, negotiation and execution of clinical trial agreements (BRANY CTAs) on behalf of the School of Medicine. BRANY will review and negotiate the terms of the BRANY CTAs pursuant to guidelines provided by the School of Medicine and the OCT. Before any BRANY CTA is signed by BRANY, BRANY will seek and obtain approval of the terms of the BRANY CTA from the OCT.

After the BRANY CTA is signed by the Sponsor and BRANY, the School of Medicine must confirm its agreement to the BRANY CTA terms by executing and returning to BRANY a Study Memorandum before the commencement of the contemplated multicenter clinical trial. On a BRANY Study Memorandum, the Principal Investigator is asked to sign their acknowledgement and agreement to its terms and conditions. Principal Investigators are also often asked to sign the BRANY CTA. The OCT, acting on behalf of the School of Medicine, will not sign a BRANY Study Memorandum until the Principal Investigator has acknowledged their review and agreement to the terms of the BRANY CTA by signing the BRANY Study Memoranda.

BRANY CTAs are subject to the same policies and preferences of the School of Medicine that guide the review and negotiation of CTAs in the OCT. The OCT will not sign a BRANY Study Memoranda unless the terms and conditions of the underlying BRANY CTA complies will all of the School of Medicine’s policies with respect to CTAs and clinical trials.


Important points to consider when using BRANY

  • BRANY can only be used for multi-center, industry sponsored trials

  • There is an application process for projects sent to BRANY initially, and regulatory submission requirements for continuations, amendments, and SAE reporting by the PI/research team. Please refer to the BRANY guidance information for details.

  • All trials being sent to BRANY must first be authorized by the OCT. This is done by submission of a protocol and notation indicating this project is going to BRANY. An NYU Study number is required for BRANY studies. The OCT generates these numbers upon request.

  • BRANY does not perform NYU-required regulatory work – i.e. research billing plans, Medicare-coverage submissions or Medicare Coverage Analysis. These procedures are completed by the OCT. The NYU approval process applies to all BRANY studies

  • BRANY is available to provide monitoring services for investigator initiated studies

BRANY Submission Procedure

  • Submit your protocol to the Research Manager of your therapeutic area in the OCT.

  • Request an NYU study number by emailing the following information to both Santos.Rivera@nyumc.org and Sunita.Latchman@nyumc.org
    • PI
    • Title of Study
    • Sponsor
    • Indicate that the study will be processed through BRANY

  • Submit the required BRANY IRB application form and required documentation. Please contact Camille Bruno at 516-470-6900 for any initial questions.

BRANY Services and Process

  • Finances/Budgeting - It is important for the PI/research team to be part of the budgeting process. The hospital applies the research-rate to research-related items. The budget must adequately cover those costs. Make sure the PI/Research team reviews and approves the budget prior to BRANY finalizing with the sponsor. The OCT will not approve inadequate budgets and will ask BRANY to renegotiate, delaying the start of the trial.

  • Contract Negotiation – The BRANY team will negotiate your contract. The NYU legal team will review it before it is considered final to be sure that all NYU School of Medicine policies are upheld.

  • BRANY IRB - Approval typically is reported to the PI/research team separately from the execution of the contract and budget. Please note that BRANY IRB approval does NOT indicate the research trial can begin at NYU.

  • BRANY MEMO - After IRB approval and contract/budget finalization, a ‘BRANY Memo’ is generated and signed by the PI and by BRANY. The OCT then receives a copy of the Study Memorandum. The OCT is the final signature on the memorandum. After all signatures are in place the approved billing plan is forwarded to the PI/research team and the NYUHC research team, if applicable.

Start of the research project can only occur after the Study Memo is signed and written approval from the individual institutional research committees is received.

  • Financial Account (FAME) - The OCT creates a research study account in the FAME system. Checks are received from BRANY throughout the trial and deposited to this account.

  • Regulatory Submission Throughout the Trial - Amendments, SAE’s, and changes to the consent must be done through the PI/research team to BRANY using their appropriate forms found on the BRANY website at http://www.brany.com.

The OCT is accessible and willing to help with any challenges arising from the use of BRANY. Any difficulty or problems with BRANY services should be communicated to the appropriate Research Management Coordinator in charge.