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 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT06931860
Description:
Data being used for this project involves protected health information that requires special training and completion of research proposals, IRB applications and data use requests directly with University of California San Diego Health System to obtain access. Therefore, we do not anticipate creating unique data resources as part of this study. If researchers receive permission via IRB applications and data use requests to work with these data, we will make available individual-level scientific data used in our study.
The rationale is based on restrictions put forth as part of our Institutional Review Board (IRB) protocol and the need to protect study participants from risks associated with their participation. Specifically, our study outlines that data access will be limited to study personnel and will only be accessible for those individuals who have IRB-required training with access to a secure HIPAA research server.
Study:
NCT06931860
Study Brief:
Head to Head Trial of Mailed Cologuard to Mailed FIT