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 @ 1:14 PM
Ignite Modification Date:
2025-12-24 @ 1:14 PM
NCT ID:
NCT03963895
Description:
All subject-level clinical, laboratory, samples and imaging data as well as protocols, informed consent forms to participate in the trial, data dictionary, and code book will be preserved for data sharing. Shared data will be deidentifed and all raw data generated in connection with this study will be retained by the Investigator's institution.
All data will be shared with controlled access. Prior to granting access outside of the Sponsor's archive, data will be deidentified by removing all 18 direct identifiers according to HIPAA Privacy Rule's Safe Harbor.
Study:
NCT03963895
Study Brief:
Safety and Efficacy Study of AB002 (E-WE Thrombin) in End Stage Renal Disease Patients on Chronic Hemodialysis