FAQs for Down Syndrome Clinical Cohort Coordinating Center (DS-4C)

The DS-4C, as described in NOT-OD-23-135, is conceived as a coordinating center that will be responsible for overall Down Syndrome Cohort Development Program (DS-CDP) coordination and outreach to support development of new cohorts of people with Down syndrome, and curate the metadata from the new cohorts. The DS-4C will provide resources that will support cohort development, to include longitudinal deep phenotyping and biospecimen collection. The research questions will be focused on activities of the four cores: (1) Administrative Core, to oversee the study operations, to support a call center that facilitates acquisition of outside records, additional data collection, and longitudinal contact with patients, and to provide capitation costs to the Cohort Research Sites (DS-CRS) for each recruited subject; (2) Outreach Core, to oversee communication with the DS community and address issues of diversity, equity, inclusion, and accountability (DEIA) among research subjects and/or investigators; (3) Cohort Core, to coordinate and lead the implementation of the common protocol developed in conjunction with the DS-CRS awards and the DS-Biorepository and oversee data collection and data quality; and (4) Data Management Core, to ingest, aggregate, integrate, harmonize, and curate data collected by the DS-CRS and ensure they are shared through the INCLUDE DCC (https://includedcc.org) Data Hub.

It is not necessary for DS-CRS applicants to coordinate with a DS-4C applicant as part of the submission process. The two programs will be competed separately, but the successful awardees will be brought together to collaborate on a shared phenotyping protocol and biospecimen collection effort, known as the common protocol.

The Administrative Core will include activities associated with recruitment and enrollment costs as well as training of staff to administer the phenotyping protocol, along with costs associated with materials for testing, evaluation, and subject evaluation as part of the common protocol. However, biospecimen collection will be coordinated by the DS-Biorepository, which will cover the costs of assembling biospecimen sample collection kits, as well as their distribution and tracking, including payment of shipping costs for submission of samples from the DS-CRS sites to the DS-Biorepository.

The Outreach Core will coordinate outreach activities for the entire DS Cohort Development Program, including a call center to triage incoming requests from researchers, participants, and families. The call center will direct referrals and follow-ups of enrolled participants in partnership with the DS-CRS sites that perform the actual recruitment. We expect the Outreach Core to facilitate longitudinal follow-up of enrolled subjects with periodic data collection appropriate to the age range of subjects being recruited. Outreach to diverse communities is described in responses to questions about the DS-CRS above; essentially, each CRS application is encouraged to include at least one partner from low-resourced institutions or institutions serving groups underrepresented in biomedical research, as well as members of local Down syndrome and other community partners.

The Cohort Core will partner with the DS-CRS sites and the DS-Biorepository during the first year of the awards to develop a common protocol based on the protocols proposed by the DS-CRS applicants. We recognize that data collection of medical records, neurodevelopmental tests, and biospecimens vary; thus, we expect that a DS-4C application is likely to have a multidisciplinary leadership team to direct the program. Subsequently, staff from this core will guide the implementation of the common protocol.

The Data Management Core will help coordinate the data ingest and transfer to the INCLUDE DCC. We expect the DS-4C to develop productive and efficient connections with the INCLUDE DCC to facilitate such linkages and enhance data harmonization and integration to promote sharing with the broader DS community, consistent with the goals of the NIH Data Management and Sharing Policy (https://sharing.nih.gov/data-management-and-sharing-policy). Applicants are encouraged to reach out to the INCLUDE DCC for guidance and a letter of support for their proposal.