QD-SOPs

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  • collect pre requisites:research idea, dataset/data dictionary
  • take the blank QD template and attempt to formalize it along the lines of QD by populating the blank template
  • use google docs for sharing the document with the team members, if any (alternatively word documents can also be used)
  • use QD template and guidance document and QD examples to understand the components of QD
  • once the QD is populated primarily, inclusion exclusion criteria, pass on the draft QD and the dataset to statistician for descriptive statistics.
  • this estimate will give you rough idea about the number of patients available for the analysis in your study.
  • revise the QD, if needed, as per the descriptive statistics provided by the statistician (for example, alter the inclusion-exclusion criteria to increase the sample size)
  • once the QD is finalized pass on the QD to the statistician, along with dataset, for analysis.

SOPs: how to populate the QD

Image:QD SOPs image.JPG