Protocol Section

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 @ 4:02 AM
Ignite Modification Date: 2025-12-25 @ 4:02 AM
NCT ID: NCT05542602
Description: The final datafile will be available for sharing. This will include demographic data and raw, derived, and standard scores. Item-level data will be available including raw item-level data with variable and value labels, all computed variables created during scoring, and all scale scores for standard scores. A data codebook and dictionary that lists each measure, variable name/label, scoring instructions, and supporting references will also be available. Each subject will be assigned a unique identification number so that no personally identifiable information is present. The principal investigator will receive requests for data-sharing, and ensure the datafile and supporting documents are transferred to the requesting individual. Other study-related materials and products will also be made available upon request (e.g., study protocol, informed consent form, etc.). The final research data will also be submitted to the NIMH Data Archive and will be accessible to other researchers.
Study: NCT05542602
Study Brief: Study of a Paraprofessional-Delivered After-School Social Intervention for Autistic Children