Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT04222556
Description:
This study, conducted on an American Indian reservation, is under the oversight of the tribal Research Review Board (RRB). Representing a sovereign tribal nation, the RRB asserts ownership of data and limits how data can be used and shared. To ensure compliance with RRB requirements, the Data Access Committee (DAC) at the Centers for American Indian and Alaska Native Health at the University of Colorado Anschutz Medical Campus will manage data access. The DAC has a detailed process to ensure compliance with RRB protocol. Users will be required to sign data use agreements stipulating commitment to: 1) abide by all tribal research review requirements, including obtaining approval for secondary analysis before accessing data and following review procedures for dissemination; 2) use data only for approved research; 3) protect individual and, if relevant, community confidentiality; 4) secure data using appropriate computer technology; 5) destroy or return data after analyses are complete.
Study:
NCT04222556
Study Brief:
Evaluation of Thiwáhe Gluwáš'Akapi Substance Use Prevention Program