62 - Documentation, Informed Cons...
62 - Documentation, Informed Consent, and Safety Reporting (S23E3)

From Concept to Medicine - A Comprehensive Drug Development ... by Jim Mitchell

Episode notes

This episode serves as a refreshing dive into the key aspects of documentation in clinical trials, making it much more than a dry overview. We'll journey through aspects of informed consent procedures, adverse event reporting, and the very best record-keeping practices.

Ultimately, the intention of this exploration is to provide reliable guidance on how to maintain accurate audit trails. By the end, it will be much more clear that all documentation needs to not only meet regulatory standards but also should support continuous quality improvement.

Throughout the episode, we'll illuminate the crucial role of documentation in all facets of the process. This also incorporates the documentation's role in the ethical process of informed consent, which can give a sense of security to the research.

A look into the key regulations set ou ... 

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