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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT04477005
Description:
All personal identifiable information collected during the study will be coded, depersonalised with unique codes for each patient. The study will be compliant with the requirements of the General Data Protection Regulation 2018 and the Data Protection Act 2018.
The CRF will only collect the minimum required information for the purposes of the trial. CRFs will be held securely, in a locked room in a locked cupboard.All patient data will be stored in an encrypted computer with password access at the NIHR Nottingham BRC, Nottingham University Hospitals NHS Trust and the University of Nottingham. Members other than the direct care team will not have access to this data.
Study:
NCT04477005
Study Brief:
Archimedes Bio-degradable Bile Duct Stent Study