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 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT04265105
Description:
Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 3 years after study completion (last patient, last visit). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants.Monitoring, audits, and REC review will be permitted and provide direct access to source data and documents. The Lead PI and the researcher assigned by her will have access to the stored data. Only the CRCs and Lead PI working on this study will be eligible to obtain the data from the participants during data collection visits.
Study:
NCT04265105
Study Brief:
Fluticasone-Vilanterol Once Daily Dose for the Treatment of Mild Asthma in Adults