FDA Explains How to Craft a Data Management Plan

Regulatory NewsRegulatory News
| 23 October 2018 | By Zachary Brennan 

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:

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She also offered a series of questions that sponsors should review in crafting their data management plans, including:
  • How will the data be created?
  • How will the data be captured and in what format?
  • How much data will be collected? And how often should it be collected?
  • How will metadata be created, captured and managed?
  • What tools or software will be required to read or view the data?
  • How will everyone understand the data?
  • And finally, what will be the quality assurance and quality control mechanisms at each stage?
QA and QC are important so that certain deficiencies do not develop. An earlier presenter also noted common clinical investigator Good Clinical Practice (GCP) deficiencies:

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