USA – FDA Explains How to Craft a Data Management Plan

Although the term “data management plan” is not included in the US Food and Drug Administration’s (FDA) regulations, Cynthia Kleppinger, senior medical officer at FDA, explained Tuesday at a joint FDA/UK’s MHRA event on how necessary such a plan is for sponsors.

So, what is a data management plan? According to Kleppinger, it’s a roadmap to achieving reliable, high-quality and statistically sound data — a living document necessary throughout the lifecycle of a study that should link to the many standard operating procedures (SOPs).

Begin by reviewing the protocol and project, she said in helping companies formulate such a plan, explaining that there should be one data management plan per study. Hire a knowledgeable team and decide who’s going to be responsible for what, she advised. “And be prepared for changes, because they will happen. »

As far as what should be included in such a plan, Kleppinger offered the following slides…