Early phase clinical trials have a larger number of protocol amendments as new information, often emerging safety issues are identified, and inform the progress of the trial. Non-serious events of ...

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved Sanofi's proposal for protocol amendment of the clinical trial of ...

“Protocol amendments are very common, so one IRB facilitating everything for all the sites in the trial will help tremendously,” Brennan said. “A sponsor is right back where they started if ...

Develop a comprehensive internal audit program template for any specified process within banking, credit unions, or fintech firms. The template should include the following components: Create ...

Audit program for ICAAP audit process It's important to understand that an ICAAP audit program must be tailored to the specific institution's size, complexity, and risk profile. However, I can ...

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