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 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT06682650
Description:
A complete NCI-approved data management and sharing plan is available from the contact PI upon request. The data and metadata from this project will be archived at the Inter-university Consortium of Political and Social Research (ICPSR). ICPSR is a CoreTrustSeal certified repository providing long-term access to and preservation of data packages. Access and distribution of data in the data repository from individual enrolled patients will conform to de-identified data set regulations i.e., PHI identifiers will not be included, other than CRC screening order, CRC schedule and completion dates (which will be included as days since enrollment i.e. clinic inception), and participant/enrollee age in years.
Aim 1 analytic quantitative datasets will include aim 1 outcomes, clinic identifier, study arm, demographic participant/enrollee characteristics, Aim 2 NOMAD survey data, qualitative data from implementation interviews and meetings, and related metadata.
Study:
NCT06682650
Study Brief:
Implementation of a ColoRectal Cancer Screening Tool in US Primary Care Practices - Usual Quality Improvement (10 Clinics) vs Normalization Process Theory-Participatory Learning in Action (10 Clinics)