Via media: Role and responsibilities of the independent safety officer
| Autor: | Barbara N. Hammack, M. E. B. Holbein, Ann J. Melvin, Tamsin A. Knox |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
030213 general clinical medicine
conflict of interest Process (engineering) Research Methods and Technology Officer 03 medical and health sciences 0302 clinical medicine 030212 general & internal medicine humans risk Safety monitoring safety officer Protocol (science) clinical trials as topic Minimal risk business.industry trial oversight Conflict of interest Charter General Medicine Public relations monitoring Special Communications Data quality Safety business |
| Zdroj: | Journal of Clinical and Translational Science |
| ISSN: | 2059-8661 |
| DOI: | 10.1017/cts.2019.393 |
| Popis: | Every research study that includes volunteer participants requires safety assurances in proportion to the risks of the study. Investigator-initiated clinical research can present unique regulatory challenges particularly for studies with a risk profile that warrants more oversight than minimal risk but less than for large, commercial, or high-risk research. The use of an independent safety officer (ISO) offers a middle way of right-sizing oversight to match the risk. ISOs are clinicians or researchers with relevant expertise who are independent of the investigator and the research study. Their relationship to the study is defined by a formal charter which is aligned with the protocol and Data and Safety Monitoring Plan to address the oversight process, responsibilities of the ISO, and clearly describe the variables to be monitored. The ISO responsibilities include reviewing safety data, adverse events, recruitment, demographics, study progress, data quality, protocol changes, and any new scientific information that pertains to the trial. Finally, the ISO reports in their review on any significant findings may propose modifications to the study or a need to stop the trial. |
| Databáze: | OpenAIRE |
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