Data and Safety Monitoring

University Of Iowa, Iowa City IA

Investigators

Linked publications, trials & patents

Abstract

In October 1, 2003, the revised data safety and monitoring (DSM) plan for the Holden Comprehensive Cancer Center was implemented and the HCCC DSM plan was approved by the NCI. Using the guidelines agreed upon between the HCCC and the NCI, the DSMC was charged with 1) monitoring all adverse reactions observed on University of Iowa investigator initiated cancer trials 2) monitoring compliance with the IRB approved protocol, with respect to eligibility, dosing, meeting reporting requirements and adequately maintaining records 3) assigning risk levels for new investigator initiated studies to assure adequate monitoring of protocols with more serious toxicity. These procedures ensure the safety of patients participating in clinical trials. In accordance with the NIH policy on procedures for data and safety monitoring of clinical trials as set forth in (http://qrants.nih.gov/qrants/quide/notice-files/not98-084.html and http://grants.nih.gov/grants/guide/noticefiles/ NOT-OD-00-038.html). all Principal Investigators of Clinical Trials are required to submit a general description of a data and safety monitoring plan as part of a new research protocol. The HCCC's DSMC has a separate and distinct function from the PRMC or IRB. Its primary tasks are to: [unreadable] prospectively screen all patients entering HCCC investigator-initiated trials for trial-specified eligibility. The study coordinator delivers a completed eligibility checklist, with test results, to the safety officer, who verifies that the inclusion and exclusion criteria are met. Questions or concerns about eligibility are discussed with the DSMC chair and/or the Study Monitor. The safety officer then communicates DSMC approval, questions or concerns to the research team before the subject is enrolled in the trial [unreadable] review accrual to trials [unreadable] assess safety by reviewing all severe adverse events and ensure timely and appropriate reporting to oversight agencies (e.g. NCI, FDA) [unreadable] review audits of selected trials [unreadable] conduct .audits for data veracity. The DSMC has also functioned as an educational tool helping new investigators understand their obligations by providing the DSM plan to investigators, and through one-on-one consultation of DSMC personnel with investigators. The DSMC constructs flow sheets for the monitoring of each investigator initiated trial which allows the investigators for each trial to keep up with the schedule of tests and observations required by their own trial.