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 @ 5:04 AM
Ignite Modification Date:
2025-12-25 @ 5:04 AM
NCT ID:
NCT03733418
Description:
This data sharing plan is only pertinent to data collected specifically for VIOLET-BUD. Because VIOLET-BUD is an ancillary study to a Prevention and Early Treatment of Acute Lung Injury (PETAL) network study, the same data sharing plan will be instituted as the PETAL Clinical Coordinating Center. Limited access data sets will be prepared and provided to the NHLBI in accordance with National, Heart, Lung and Blood Institute (NHLBI) policies on data sharing: http://www.nhlbi.nih.gov/research/funding/human-subjects/set-preparation-guidelines.
VIOLET-BUD data will be made available on the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). In addition to the data, documentation such as data collection forms, study procedures and protocols, data dictionaries and algorithms for calculated data elements and descriptions of all variable recoding performed will also be provided.
Study:
NCT03733418
Study Brief:
Vitamin D to Improve Outcomes by Leveraging Early Treatment: Long-term Brain Outcomes in Vitamin D Deficient Patients