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:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT05807594
Description:
To gain access to restricted data, researchers must submit a User Agreement and Distribution Agreement. The User Agreement specifies that the investigator will only use the data for the specific project as described. The User Agreement is not transferable to another recipient or facility and data may only be shared with others by obtaining them directly through the PI. The recipient must also agree to not attempt to establish the individual identities of participants who provided the data. The Distribution Agreement includes a detailed description of the proposed project. The proposal must include personal identification and institutional affiliation, a current resume, source of funding, a detailed summary of the proposed research including a statement of why publicly available data are insufficient, and a complete list of data requested, including data system, files, years, variables, and the like. The PI and a subcommittee of the research team will review all proposals.
Study:
NCT05807594
Study Brief:
Healthy Mom Zone Gestational Weight Gain Management Intervention 2.0