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 @ 1:50 PM
Ignite Modification Date:
2025-12-24 @ 1:50 PM
NCT ID:
NCT07150195
Description:
The investigators are currently undecided regarding sharing of Individual Participant Data (IPD). The primary reason for this uncertainty is to ensure full compliance with all regulatory obligations and to uphold the confidentiality commitments made to the study participants during the informed consent process.
Therefore, sharing IPD would require further review and approval by the relevant Institutional Review Board (IRB)/Ethics Committee, and in some cases, may necessitate re-consenting participants, which is not always feasible.
The investigators acknowledge the importance of data sharing for scientific progress. A final decision will be made following the completion of the study and publication of the primary results. The investigators will formally consult with the IRB/Ethics Committee and the data protection officers to determine if and how the data can be shared in a manner that is fully compliant with Chinese regulations and international standards for data privacy.
Study:
NCT07150195
Study Brief:
Study on Proteomic and Microbiome Changes in Patients With Hepatic Encephalopathy (HE)