FP Primary Antibiotic Coated Nail to Prevent Infection: A Clinical Trial

Grants and Contracts Details

Description

Major Task 1: Study Initiation Subtask 1: Finalize protocol Subtask 2: Develop case report forms (CRF) for data capture. Subtask 3: Program and pilot data capture using REDCap. Subtask 4: Obtain initial IRB approval at CMC Subtask 5: Distribute approved protocol and obtain IRB approval. Subtask 6: Certify sites to begin screening and enrolling patients, and conduct initiation calls Major Task 2: Enroll and Follow Patients in Prospective Clinical Trial Subtask 1: Screen and enroll eligible patients Subtask 2: Follow all enrolled patients for 12 months Subtask 3: Generate and distribute monthly enrollment and follow-up reports to manage study progress. Provide on-going training and support to address problems with enrollment and follow-up as they are identified. Subtask 4: Generate and distribute data quality reports to monitor data completeness, check for errors and inconsistencies. Major Task 3: Data Analysis Subtask 1: Develop final data files and conduct analysis. Subtask 2: Write final report and peer-reviewed publications
StatusActive
Effective start/end date9/30/219/29/22

Funding

  • Atrium Health: $2.00

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