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Table 3 Organizational roles and responsibilities

From: Design of the Building Research in CRC prevention (BRIDGE-CRC) trial: a 6-month, parallel group Mediterranean diet and weight loss randomized controlled lifestyle intervention targeting the bile acid-gut microbiome axis to reduce colorectal cancer risk among African American/Black adults with obesity

Role

Responsibilities

Principal Investigators

- Oversee all research-related activity and personnel

- Publish results in a timely manner

Data and Safety Monitoring Committee (DSMC)

-Review the study protocol for any major concerns prior to implementation

-Regularly review and evaluate the accumulated study data for participant safety, study conduct, and progress

-Make recommendations concerning the continuation, modification, or termination of the trial

Data Manager

-Organizes electronic data

-Data verification

-Assist with data safety

Project Director

-Manages recruitment and data collection

-Manages budget and staff

-Trains and certifies staff

-Interfaces with IRB to maintain ethical standards