What does "good documentation" entail in the context of ICH E6?

In the context of ICH E6, "good documentation" encompasses the accurate and timely recording of data. This principle is critical because proper documentation supports the integrity and reliability of clinical trial data, which is essential for regulatory approval and the overall credibility of the research.

Timely and accurate documentation ensures that findings and events are recorded while they are fresh, reducing the risk of inaccuracies or omissions that may occur if notes are taken long after an event. Furthermore, precision in capturing data allows for consistency in analyses and conclusions, fostering confidence in the study's results and compliance with regulatory expectations.

Good documentation practices create a transparent trail that can be audited, facilitating oversight and accountability in the clinical trial process. This is crucial in the context of ICH E6 guidelines, which aim to ensure that clinical trials are conducted ethically and that data is reliable and verifiable.

The other approaches mentioned, such as only documenting significant events or keeping informal notes for personal reference, do not fulfill the rigorous standards expected in clinical research documentation. They lack the comprehensiveness and formality required to maintain the quality and validity of clinical trial data.