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 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT06831318
Description:
All raw data accessibility will be limited to the PI, data manager, GRAs, and the statistician.
Data will be shared under a two-tier distribution system. All data that can be de-identified will be shared. Data with specific confidentially risks, such as individual-level digital recordings will not be shared publicly because of the difficulty masking the identity of participants. Data with increased risk of reidentification will be shared under a data-use agreement that clearly establish use rules to facilitate respondent confidentiality.
Even though the final dataset comprising of questionnaire will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. These types of data will be only shared under a data sharing agreement: individual-level digital recordings, medical records review, and qualitative data from participants interviews (because of the difficulty masking).
Study:
NCT06831318
Study Brief:
Community Health Worker-Led Transition Support for Persons Living With Dementia and Caregivers