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 @ 3:22 AM
Ignite Modification Date:
2025-12-25 @ 3:22 AM
NCT ID:
NCT06057805
Description:
The proposed study will involve a small sample (50 subjects) recruited from the Diabetes center at Woman's Hospital. Despite the removal of all identifiers, it would be difficult if not impossible to protect the identity of of all subjects. So even though the final data set will be stripped of identifiers prior to release for sharing, the investigators assume that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, the investigators will make the de-identified data and associated documentation available to users only under a dat-sharing agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
Study:
NCT06057805
Study Brief:
The PPCGMS Intervention After GDM Trial