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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT06435156
Description:
Datasets of pseudo-anonymised IPD generated/analysed during the current study will be available upon request from the Chief Investigator (CI) Dr Ify Mordi (i.mordi@dundee.ac.uk) at the end of the trial (i.e. when all endpoints/outcomes have been met, key analyses are complete and results published in peer-reviewed scientific journals). Data will remain available for at least 25 years.
Data will only be released for legitimate secondary research purposes, where the CI agrees that the proposed use has scientific value and will be carried out to a high standard (in terms of scientific rigour, information governance and security), and that there are resources available to satisfy the request.
Data will only be released in line with participants' consent, all applicable laws relating to data protection and confidentiality, and any existing contractual obligations. No individual participant data will be released before an appropriate agreement is in place setting out the conditions of release. The agreement will govern data retention, usually stipulating that data recipients must delete their copy of the released data at the end of the planned project.
Study:
NCT06435156
Study Brief:
Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes