Step 1: Submit a request to participate in the N²QOD to the NeuroPoint Alliance (NPA)
Interested sites should contact the NPA Administrator 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 Administrator will then provide the necessary Project and Regulatory documents, and work with your business contact to complete the required N²QOD agreements.
Step 2: Review the N²QOD Project Description and Lumbar Spine Module. Submit documents to IRB or Institutional Quality Improvement Board (see below)
The NPA Administrator will provide each site with the following documents for review and submission to local Institutional Review Board (IRB) or Institutional Quality Improvement Board (QI):
N²QOD Project Description: General overview of NeuroPoint Alliance and N²QOD along with a review of relevant federal regulations. This document will be updated as the project matures.
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.
N²QOD Lumbar Spine Module Description: Detailed description of the lumbar module data elements. Each new N²QOD module will be accompanied by a separate description. A Cervical Module Description is now undergoing final review and will be activated in 3rd or 4th quarter 2012.
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 N²QOD 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 recent 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, Lumbar Spine Module 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 email@example.com. Address: 5550 Meadowbrook Drive, Rolling Meadows, IL 60008. Phone: 847-378-0549, or t888-566-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), Business Representative (if changed from initial contact. The Business Representative will serve on the N²QOD Business Committee), and site Data Coordinator. For more information on the Data Coordinator Role, see the Data Coordinator Job Description.
Step 4: Complete the N²QOD Participation, Data use and Business Associate Agreements
Review and execute the N²QOD Participation, Data Use, and Business Agreements. 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 firstname.lastname@example.org. Address: 5550 Meadowbrook Drive, Rolling Meadows, IL 60008. Phone: 847-378-0549, or t888-566-AANS (2267)), along with payment for the first-year participation fees.
Step 5: Contact the Vanderbilt Institute for Medicine and Public Health (VIMPH)
Upon completion of the N²QOD agreements and regulatory approval, make contact with the N²QOD Project Manager at VIMPH: Joan Gottesman, (email@example.com). Confirm and provide VIMPH with contact information for your site's Clinical Representative and Data Coordinator.
Step 6: Complete N²QOD preparation and Training
VIMPH will provide the site Data Coordinator with the N²QOD Project Objectives and Data Collection Guidelines, and the N²QOD User Manual for review.
NPA will provide site Data Coordinator with a link to the online Lumbar Module Training Demo.
Upon completion of these steps, VIMPH will initiate site orientation and REDCap™ training sequences. Access to the N²QOD password-protected website will be provided prior to patient data collection.
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