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 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT04441593
Description:
For proposals that contain analyses that are not already planned or in progress, the investigators will make data available for collaboration with a study investigator, provided IRB and other appropriate regulatory approvals are obtained (including but not limited to Federal and Boston University IRB review and approval). Data to be shared will be de-identified to minimize the risk of deductive disclosure. Documentation will be provided for all shared data including copies of data collection forms, schedule of study assessments, data dictionaries documenting all original and derived variables, descriptive statistics for all variables included in the data sets, and a written description of the study conduct and noteworthy details anticipated to potentially affect data interpretation. Costs associated with producing data sets and analysis will be the responsibility of investigators seeking the data.
Study:
NCT04441593
Study Brief:
Internet-based Video-conferencing to Address Alcohol Use and Pain: a Pilot Trial