Under the auspices of the NINDS, working groups (WG) composed of domestic and international neuroscience experts develop disease-specific CDEs. In this process, clinicians and investigators with disease-specific expertise are responsible for the development and vetting of the CDEs while the NINDS supervises and disseminates the resulting CDE products.
The NINDS Program Directors and their contractor work together to facilitate the CDE development process. They are jointly referred to as the NINDS CDE Team (NCT).
CDE recommendations (Version 1.0 or higher) are vetted by the entire working group (WG) before they are released for public use. From the first WG meeting it typically takes at least 12 months to develop final recommendations. Based on these recommendations, CDE standards are created and disseminated to the public via this Web site. The NINDS encourages the use of the CDEs by investigators world-wide who are conducting clinical research studies.
The NINDS has created oversight committees to continually review the General and disease-specific CDEs for utility and need. These oversight committees ensure that the CDEs remain dynamic standards that continue to improve and adapt to the needs of clinicians and investigators.
The steps in the process from data to CDEs are:
- NCT has kick-off meeting to discuss development of disease-specific CDEs
- NCT performs two concurrent steps:
- Reviews current data collection practices
- Current literature
- CRFs from recent studies
- Final data sets from completed studies
- Clinical data standards / regulatory requirements
- Assembles experts in research area to form CDE WG
- Invite experts to participate
- Divide WG into smaller subgroups to focus on identifying CDEs in specific domains
- Nominate Chairs for WG and subgroups
- Arrange kick-off meeting of WG and teleconferences for subgroups
- Reviews current data collection practices
- WG defines scope and content of CDEs
- Subgroups meet by teleconference every 4-6 weeks to develop CDEs
- Teleconferences last one - two hours
- Members have some preparatory work between calls
- NCT and WG jointly prepare first draft of CDE materials
- Catalog of recommended CDEs
- Recommended standardized instruments (where applicable)
- Template study forms
- Additional instructions and guidelines
- WG meets to finalize Version 1.0 of CDEs and discuss next steps
- NCT revises CDEs based on WG's feedback
- WG approves publishable version of CDEs
- NCT posts CDEs on CDE Web site for public use
- NCT and WG jointly promote use of CDEs in clinical research community
- Clinical research community uses CDEs and submits feedback via Web site
- NCT presents proposed changes to WG on predetermined basis
- WG decides what revisions should be made to CDEs
The process starts again at step 6.