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 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT05488795
Description:
Data Quality and Management
a. Description of Plan for Data Quality and Management - The PI will review all data collection forms on an ongoing basis for data completeness and accuracy as well as protocol compliance. A statement reflecting the results of the review will be sent to the NIH in the annual report. The EHR is the primary data source. EHR data quality will be assessed using extreme outlier data, missing data for outcome variables (i.e. office or transmitted blood pressure readings, dates of visits, participant ID), and loss to follow-up (no data for the participant appears in EHR, e.g. due to relocation, left practice etc). Note: clinical staff will conduct outreach to all participants as part of sound clinical practice. Regular data checks and data cleaning will be deployed to optimize data quality. Multiple imputation methods will be used as necessary to address missing data as described in the statistical analysis.
Study:
NCT05488795
Study Brief:
Team-Based Home Blood Pressure Monitoring