Step 1: Submit a request to participate in the N²QOD to the NeuroPoint Alliance (NPA)
Interested sites should contact the NPA at info@NeuroPoint.org or 847-378-0549 with a request to participate in N2QOD. Sites should provide NPA with an initial business contact. The NPA will then provide the necessary Project and Regulatory documentation, and work with your business contact to complete the required N²QOD agreements.
Step 2: Review the N²QOD Project Description(s). Submit documents to IRB or Institutional Quality Improvement Board (see below)
The NPA will provide each site with the following documents for review and submission to local Institutional Review Board (IRB) or Institutional Quality Improvement Board (QI):
The Project Description Manual references several regulatory documents and literature articles related to registry projects and this information is contained in a separate PDF file: Project Description Attachment-Regulatory Documents. A regulatory manuscript published in the JNS' Neurosurgical Focus in 2013 is also provided for reference.
N²QOD Module Descriptions: General overview of the NeuroPoint Alliance and N²QOD along with a review of relevant federal regulations. Detailed project descriptions of the N²QOD module data elements. Each new N²QOD module will be accompanied by a separate description. These documents will be updated as the project matures.
IMPORTANT information related to your IRB submission:
The NPA regards the systematic collection of data related to the outcomes of care (including the collection of patient reported outcomes through validated assessment instruments) with the primary intent of promoting quality improvement as an important extension of existing methods of neurosurgical care. As such, and based on our interpretation of existing federal guidelines relevant to clinical registries, our organization believes that the N ²QOD project is best designated as a non-research, clinical quality improvement effort, exempt from IRB review and the requirement for informed consent.
This particular interpretation of federal regulations and guidelines is supported by the determination of IRBs at the significant majority of participating N²QOD programs, and a review of the N²QOD project by the HHS Office of Human Research Protections and Office for Civil Rights (See Project Description and Regulatory Documents). Notwithstanding these opinions, we recognize that certain local IRBs may wish to review the N²QOD project to make their own interpretation of the guidelines relevant to this project. In that regard, it is our present recommendation that participating sites allow this project description to be reviewed by their local IRB and/or Quality Improvement Committees prior to implementation of the N²QOD project.
We specifically recommend that sites submit the Project Description(s) and Regulatory Documents for expedited review with a request for designation of "not regulated, quality improvement" project.
In the rare circumstance that a local IRB may designate this project after initial review as a research effort despite the OHRP opinion that the participation of sites in the N²QOD project does not constitute "human subjects research" , sites may modify the project description into a clinical protocol submission, based on their individual IRB's document templates.
Once obtained, letters and/or final communication from individual IRBs or Quality Improvement Committees should be sent to the NPA Offices (email firstname.lastname@example.org. Address: 5550 Meadowbrook Drive, Rolling Meadows, IL 60008. Phone: 847-378-0549, or toll-free, 888-566-AANS (2267)).
Step 3: Determine site Contact Representatives
Provide NPA with contact information for your site's Clinical Representative (Physician Champion, who will also serve on the N2QOD Operations Committee and will oversee N2QOD activities for your center), Business Representative (if changed from initial contact), and site Data Coordinator. For more information on the Data Coordinator Role, see the Data Coordinator Job Description.
Step 4: Complete the N²QOD ParticipationAgreement
Review and execute the N²QODParticipation Agreement which include exhibits for the Business Associate and and Data Use Agreements. Please note, the three agreements operate as one contract and should be reviewed in their entirety. Participation in N2QOD can be facilitated if you initiate the contract process at the same time as the regulatory review. Completed agreements should be sent to the NPA Offices (email email@example.com. Address: 5550 Meadowbrook Drive, Rolling Meadows, IL 60008. Phone: 847-378-0549, or toll-free 888-566-AANS (2267)), along with payment for the first-year participation fees.
Step 5: Complete N²QOD Registration and Training
Upon completion of the N²QOD agreements, regulatory approval and 1st year payment, the NPA will forward site contact information to the N²QOD team at the Vanderbilt Institute for Medicine and Public Health (VIMPH).
Your site Data Coordinator will also be provided with access to the N²QOD Training and Education Modules. Once training has been completed by the site Data Coordinator, the N²QOD Project Coordinator at VIMPH will schedule a one-to-one site orientation teleconference to review N²QOD training and address any remaining questions.
Access to the N²QOD password-protected registry website will be provided prior to patient data collection.