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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT03534934
Description:
Clinical exam, questionnaire, and image-derived data will be made available to other researchers who request it formally. The data will be de-identified and linked only by code numbers. To further minimize the risk of breaches of confidentiality, we will establish data-use sharing agreements, and consider employment of electronic firewalls, locked storage facilities, password authentication of users, audit trails, and disaster prevention/recovery plans. We will stipulate that data are used only for research purposes, that proposed research using the data will be reviewed by an Institutional Review Board, and data will not be transferred to other users. The data would be available upon completion of necessary data management and statistical analyses. At that time, data could be provided on appropriate storage media via mail. Data files would be provided in SAS format, with PDF documentation files. We also will provide copies of questionnaires and images from which our data are derived.
Study:
NCT03534934
Study Brief:
CT-Based Modeling of Bone Micro-Architecture and Fracture-Risk in COPD