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 @ 4:49 AM
Ignite Modification Date:
2025-12-25 @ 4:49 AM
NCT ID:
NCT07199218
Description:
De-identified individual participant data (IPD) that support the results of this trial will be made available to qualified researchers after study completion and publication of the primary results. Data will include baseline characteristics, outcome measures, and safety data.
Supporting Information:
Data will be shared beginning 12 months after publication and available for up to 5 years. Access will be granted upon submission of a methodologically sound proposal and approval by the principal investigator and institutional ethics committee. A data use agreement will be required to ensure protection of participant confidentiality. Supporting documents such as the study protocol and statistical analysis plan will also be available upon request.
Study:
NCT07199218
Study Brief:
Placebo-Controlled Study of Terpenes-Enriched Cannabis Oil T1/C28 for Children With Autism