PR 680 Lecture Notes - Lecture 22: National Institutes Of Health, Data Management, Data Integrity

• School: Ball State University
• Department: Public Relations
• Course: PR 680
• Professor: Dr. Sungwon Chung

Document Summary

Data and safety monitoring in human subjects research. The reason why researchers conduct clinical trials is because they want to evaluate the safety and efficacy of new medical/behavioral interventions. This also allows the researcher to compare the risks and benefits for the participant. These studies need to have regular monitoring of what outcomes happen to make sure that there are not any unacceptable risks to the participant. This allows the researcher to change the study if need be. Data and safety monitoring board (dsmb)/data and safety monitoring committees (dsmc)/ Data monitoring committee (dmc): this is an expert committee containing people not involved or conflicted with the trial in any way. Hhs regulations: these say very little about how to monitor clinical trial data. However, it does say that the researchers have to change the study as changes show they must be made. Hhs agencies: the nih says all clinical trials have to have some sort of monitoring of data.