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…