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 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT04817059
Description:
All data will be de-identified using standards conforming to HIPAA guidelines. Consistent with the model setup by the International Data Sharing Initiative (INDI) effort, data will be distributed via the NITRC-based Functional Connectome Project (FCP)/INDI website (http://fcon\_1000.projects.nitrc.org/). The following steps will be carried out to ensure that no identifying or protected health information is released:
* All imaging files will be stripped of fields containing protected health information, and date of exam will be removed
* Anatomical images will have face information removed or obscured.
* Random ID numbers will be generated and assigned to each dataset prior to release.
Legal guardians of the child participants will be asked if they consent to having their data shared publicly, as well as privately with other University of Texas at Austin researchers. If they do not consent to having their data shared, they may still participate in the study without penalty.
Study:
NCT04817059
Study Brief:
Reducing Head Motion With Customized Head Mold in Young Children