Step 1: Submit a request to participate in the QOD to the NeuroPoint
Interested sites should contact the NPA at info@NeuroPoint.org or 847-378-0549 with a
request to participate in QOD. 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 QOD agreements.
Step 2: Review the QOD 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.
QOD Module Descriptions: General overview of the
NeuroPoint Alliance and QOD along with a review of relevant federal
regulations. Detailed project descriptions of the QOD module data elements.
Each new QOD module will be accompanied by a separate description. These
documents will be updated as the project matures.
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 QOD
project is best designated as a non-research, clinical quality improvement
effort, exempt from IRB review and the requirement for informed consent.
interpretation of federal regulations and guidelines is supported by the
determination of IRBs at the significant majority of participating QOD
programs, and a review of the QOD 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 QOD 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 QOD 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 QOD 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
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 the Site Contact Representatives
Provide NPA with contact information for your site’s
Clinical Representative (Physician Champion, who will also serve on the QOD
Operations Committee and will oversee QOD 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 QOD Participation Agreement
Review and execute the QOD Participation 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 QOD 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 QOD Registration
Upon completion of the QOD agreements, regulatory approval
and first year payment, the NPA will forward site contact information
to the QOD team at the Vanderbilt Institute for Medicine and Public Health
Your site Data Coordinator will also be provided with access
to the QOD Training and Education Modules.
Once training has been completed by the site Data Coordinator, the QOD
Project Coordinator at VIMPH will schedule a one-to-one site orientation
teleconference to review QOD training and address any remaining questions. Access to the QOD password-protected registry website will be provided prior to patient data collection.