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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT04491734
Description:
This study will be conducted in accordance with the International Council for Harmonisation (ICH) E6 R2. The Investigator agrees to maintain adequate documentation for the subjects participating in this clinical research project. The Investigator agrees to maintain accurate case report forms and source documentation as part of the case histories. Subjects will enter their data into the data capture system (REDCap). The analysis data sets will be generated from data captured in REDCap.
All documents and data shall be produced and maintained in such a way as to assure control of documents and data to protect the subject's privacy as far as reasonably practicable. All attempts will be made to preserve subject confidentiality.
Study:
NCT04491734
Study Brief:
Tolerability Study of a Novel Microbiome Therapeutic in Subjects With Gastroesophageal Reflux Disease