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

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 out in CFR 312.56 illustrates how even sponsors can use record-keeping to monitor investigators and ensure that ethical standards are followed.

This journey into record keeping will not stop at paper records alone. An introduction into the best practices for documenting electronic records will also be examined.