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Essay On Human Subject Protection

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Module 1 [Introduction and Human subject protection]
Overview In this module, a general view was provided about the clinical trial, its phases and the protection of human subjects in clinical research. In addition, the description national and international rules and regulations was reviewed. The protection of human subject in the research field is so important that the laws at the federal, state and local levels are strictly regulated. We also got a chance to get a CITI certificate which is very informative and valuable to understand the responsible conduct of research and ethics.
Key Takeaway 1 I have learned that the role of FDA is paramount. Without FDA quality control of the products is not possible. Pre-marketing and post-marketing
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Key Takeaway 1 Conducting a trial in a biased manner will lead to inaccurate and unreliable research outcomes. From this module, I determined that randomization, blinding, sample size, control groups, analysis of intent to treat population, selection of appropriate endpoints and statistics all are essential while designing a clinical trial in order to eliminate the bias.
Key Takeaway 2 The conduction of a clinical trial with the best design ensures the integrity of the collected data and the safety of the trial subjects. All the researchers should follow the ICH guidelines which offer complete guidance on how to make correct and applicable choices.
Personal Achievement(s) My accomplishment from this module is that the choice of study design is very critical. It depends on the goal of the assessment and practices of traditional medicine. Researchers should keep in mind all the elements of the design which are suitable particularly to their research question. The important point to note is that there are various types of designs and we can use different controls (placebo control, active control, etc.) to support drug approval but not every design is compliant with every situation

Module 3 [Prescription drugs and biologics]
Overview The main elements discussed in the module 3 are the difference between the prescription drugs and biologics, the responsibilities of sponsors and investigators during drug development and the available guidance for the researchers
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