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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT07223268
Description:
The team will de-identify identifiable data and assign each study participant a unique identifier (ID). The team will use the Safe Harbor method to comply with the HIPAA Privacy Rule. The Safe Harbor method removes all 18 identifiers of Protected Health Information (PHI) from data to ensure that the data cannot be traced back to one person. PI will share the individual-participant level raw data described below through deposition in a controlled-access public repository (Emory Dataverse). To preserve participant anonymity and safety, PI will not share participant interviews or navigator encounter audio recordings. We will redact interview transcripts and encounters to remove any potential identifiers. Foot images will be edited to remove identifying features, including faces. The informed consent forms will reflect these plans.
Study:
NCT07223268
Study Brief:
Comprehensive Assistance and Resources for Effective Diabetic Foot Navigation