Back to the Basics Part 2: Essential Documents
In Part 1, we discussed the TMF and why it is so critical. While all TMF documents are important, some are more crucial to a trial than others. At the core of these are the essential documents, as defined by ICH Guideline for Good Clinical Practice, E6, Section 8, “those documents which individually and collectively permit evaluation of the conduct of the clinical trial and the quality of the data produced.”