You are here: Vanderbilt Biostatistics Wiki>Sandbox Web>ChecklistForBiostatisticalReview (22 Aug 2017, ChrisLindsell)EditAttach
-- ChrisLindsell - 22 Aug 2017

Biostatistical protocol review checklist
Hypotheses/Objectives
  • Clearly articulated and consistent with aims
General design
  • General study design (observational, RCT, pragmatic etc) will effectively answer the question
  • General study design is appropriate for current state of knowledge
Population and sample
  • Population from which the sample will be drawn is representative of the population of interest (e.g. disease severity, time point during disease progression)
  • Inclusion and exclusion criteria appropriate for state of knowledge
  • Screening and enrollment processes do not introduce unecessary bias
Variable selection
  • Primary variables are clearly defined and consistent with the hypothesis/objectives
  • Algorithms used to derive variables or score outcomes assements tools are appropriate
Treatment assignment
  • Method for assigning treatments (e.g. randomization) minimizes bias
Data integrity
  • Data collection methods are sufficient to result in accurate measurement of primary variable(s)
  • Data management uses appropriate tools (e.g. REDCap)
  • Plans for monitoring or interim data checks are appropriate
Data handling rules
  • Range and consistency checks are included
  • Handling of missing data is addressed
Statistical environment
  • Statistical collaborator is engaged
  • Software is acceptable (not Excel)
  • Plans for reproducibility are stated
Analysis plan
  • Statistical approach is consistent with hypothesis and objectives
  • A plan for describing the dataset is given
  • Unit of analysis is clearly described for each analysis
  • Analysis populations clearly described (intent to treat set, per protocol set, full analysis set etc)
  • Analytical approach is justified, including consideration of assumptions and alternative approaches
  • Approach minimizes unnecesary exposure of participants to risk
Sample size justification
  • Alpha and 1-beta given for all statistical tests and justified based on state of current knowledge
  • Tests are identified as one or two-tailed and justification provided
  • Justification is based on clinically important differences
Edit | Attach | Print version | History: r1 | Backlinks | View wiki text | Edit wiki text | More topic actions
Topic revision: r1 - 22 Aug 2017, ChrisLindsell
 

This site is powered by FoswikiCopyright © 2013-2022 by the contributing authors. All material on this collaboration platform is the property of the contributing authors.
Ideas, requests, problems regarding Vanderbilt Biostatistics Wiki? Send feedback