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.”
How do we proceed in times like these? That is a question bouncing around the minds of people worldwide. For many, the answer is simply “stay at home and wait.” However, in the medical community, the show must go on. That community includes many clinical trials. Participants are actively being treated, and so it is important study teams find a way to continue. There are no elegant solutions to a pandemic, but much of what enables us to respond, both at home and in business, is our digital infrastructure.
