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:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT06043050
Description:
Due to the sensitivity of the data, the underlying data sets will not be shared publicly due to ethical/privacy restrictions. However, all analyses will be documented, reproducible and available for audit. The data dictionary will be available upon request or as appendix in the manuscript. We might consider restricted access to the raw data in a repository when the target journal deems this necessary for publication. For future collaboration with the research partners or for data transfer/sharing, written agreements on data management, privacy, data ownership and intellectual properties will be made, such as a research collaboration agreement and data sharing agreement, and discussed with the support of Legal/Privacy/RDM experts where appropriate. In line with the Netherlands Code of Conduct for Research Integrity, raw and processed will be stored for a period of at least 10 years. The LUMC has long-term storage with back-up available for this.
Study:
NCT06043050
Study Brief:
PRedicting OutcomeS in Preterm nEonates With thromboCyTopenia