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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT06584435
Description:
1. Data Scope De-identified individual participant data (IPD) Clinical study report protocols
2. Data Specifications Clinical Datasets: Demographic/ efficacy (response, survival)/ safety (adverse events) data Documentation: Informed consent templates and complete study protocols Standards: CDISC SDTM/ADaM formatted datasets
3. Access Process Timeline: Available within 18 months after trial completion Platform: Access via designated data sharing portal Review: Scientific review committee approval required
4. Usage Terms Purpose: Academic non-commercial research use only Requirements: Signed data sharing agreements mandatory Restrictions: No commercial use or re-identification attempts
5. Technical Details Format: Analysis-ready datasets with metadata Support: Provided documentation and limited technical support
Study:
NCT06584435
Study Brief:
A Study of Toripalimab in Adjuvant Therapy After Resection of High-risk Renal Cancer