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 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT07270705
Description:
As a company operating under the jurisdiction of the EU, the organization is subject to the General Data Protection Regulation (GDPR), which imposes strict requirements on the processing and sharing of personal data, including health-related information. Individual Participant Data (IPD) from clinical trials is considered sensitive personal data under GDPR.Even when data is anonymized or pseudonymized, sharing IPD with third parties-especially outside the EU-requires careful assessment of data protection safeguards, appropriate legal basis, and in some cases, additional participant consent. Unless all conditions for lawful data transfer and processing are met, including compliance with GDPR Articles 44-50 concerning international data transfers, the sharing of IPD is not permitted.For this reason, and to ensure full compliance with EU data protection regulations while safeguarding the privacy and rights of study participants, individual-level data cannot currently be shared.
Study:
NCT07270705
Study Brief:
Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Gingivitis