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 @ 5:06 AM
Ignite Modification Date:
2025-12-25 @ 5:06 AM
NCT ID:
NCT04102527
Description:
Source documents defined as any original document or object to prove the existence or accuracy of a data or fact recorded during the clinical study will be kept for 15 years by the Hospital Center; this is the hospital medical record, original results of the patient's biological examinations.
The protocol data that will be collected in the observation book and which will be considered source data can be found in the attached observation book.
Source data will be collected by the service's investigators and nurses; It will be collected in the CRF by investigators.
The data will then be entered into the Excel database by the clinical research officer and a team member (investigator, intern or IDE) for a double entry.
During or after the research, data collected on the appropriate individuals and transmitted to the sponsor by investigators will be anonymized.
Study:
NCT04102527
Study Brief:
Evaluation of the Impact of Transit Troubles in Patients Undergoing Peritoneal Dialysis