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Study Title: Investigator: IRB#:Instructions This SelfMonitoring Tool is designed for use as part of the overall Data Safety Monitoring Plan (DSMP) to assess compliance with Emory IRB policies and
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How to fill out data and safety monitoring

01
Collect data on a regular basis according to the predetermined schedule
02
Ensure proper documentation of all data collected
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Implement safety monitoring procedures to detect any adverse events or trends
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Analyze the data collected for any patterns or anomalies
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Report any findings to the appropriate authorities or stakeholders

Who needs data and safety monitoring?

01
Clinical trial researchers
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Drug manufacturers
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Medical device companies
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Health regulatory agencies

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Data and safety monitoring is the process of regularly reviewing and assessing data from a study or trial to ensure the safety of participants and the validity of the results.
Researchers, investigators, and sponsors conducting clinical trials are typically required to file data and safety monitoring.
Data and safety monitoring is typically filled out by submitting regular reports detailing the progress of the trial, any adverse events, and any protocol deviations.
The purpose of data and safety monitoring is to ensure the ongoing safety of participants in a clinical trial and to maintain the integrity of the study's results.
Information such as adverse events, protocol deviations, participant enrollment, and study progress must be reported on data and safety monitoring.
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