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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT04654260
Description:
Research data from this study will be shared via the National Database for Autism Research and NIH Data Repositories (https://nda.nih.gov/) consistent with the Yale University Policy. The data management for this study will be conducted using the OnCore system at YCCI (https://medicine.yale.edu/ycci/oncore/), which enables translation of data to de-identified data sets that can be placed online using GUID technology as specified in Federal guidelines. At the time of permission/consent/assent, participants and their parents will be informed of the data-sharing plan. Raw data generated by the project will be quality-certified by our research team (including fidelity to research procedures, proper file format, artifact removal, and de-identifying, resulting in artifact-free raw data) prior to submission to NDAR for usability. Consistent with the NDAR data sharing policy, data will be submitted, at the individual level, on all enrolled subjects.
Study:
NCT04654260
Study Brief:
Behavior Therapy for Irritability in Autism