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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT03999632
Description:
Confidentiality and Privacy:
Information about study subjects will be kept confidential and managed according to the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
Source Documents:
Source data will include the electronic health record for patient demographics, vitals, and basic laboratory results. Dictated operative notes will be maintained within the EHR as well. Lab results of inflammatory markers will be kept out of the EHR and kept in a secure file on the Cleveland Clinic server.
Records Retention:
The investigators will retain study essential documents for at least six years after completion of the research and are accessible for inspection by authorized representatives at reasonable times and in a reasonable manner.
Study:
NCT03999632
Study Brief:
Effects of Wolffia Globosa (Mankai) in Patients Undergoing Bariatric Surgery.