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«Quality Management in Clinical Trials Clinical trials are conducted to collect the data necessary to provide information for academia, industry, and ...»

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1. Pfizer and other companies are trying to employ risk-based monitoring, which would target monitoring at higher risk sites. How would you determine if a site is high, medium or low risk?

2. What are the benefits and risks associated with risk-based monitoring, in terms of ensuring quality in clinical trials?

3. Should a sponsor try to find monitors for a trial that are familiar with local practices, or should the same monitors look at data at sites in different countries to ensure consistency?

4. Sponsors usually have detailed monitoring reports prepared, and in the case of audits, detailed audit reports. Should sponsors share those with regulators, when problems arise? What would the benefits and risks, if any, be in sharing such reports routinely?

5. If some data from a site is found to be unreliable, should data from the entire site be excluded from the analysis (but noted for the regulators), or included in the analysis?

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