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The Good, The Bad, and The Ugly of Review Practices in The Clinical Sciences

by McCulley/Cuppan LLC on Oct 19, 2011

1,668 views

Why Most Document Reviews are Not Really Reviews: the importance of understanding the root causes of poor review outcomes

Why Most Document Reviews are Not Really Reviews: the importance of understanding the root causes of poor review outcomes

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The Good, The Bad, and The Ugly of Review Practices in The Clinical Sciences — Presentation Transcript

Why Most DocumentReviews are not ReallyReviews:the good, the bad, and the uglyof review practices in the clinicalsciencesThe importance ofunderstanding the root causes ofpoor review outcomes
To Bring Change• For effective CAPA you must identify and manage root cause not just the symptoms• This dictum applies absolutely to review practices
Starting Point: Know Where You Want to LookRecognize the differences between:• Practices and processes• Cooperation and collaboration• Inspection and review
Bottom-line• If you want to improve collaborative work practices, but your systems are built around cooperative processes, then you will never get the there.• Fix the process and then work on the practices
Root Cause of Poor Review Outcomes• No formal training in review• Reviewer discipline
No Formal Training Results In• Failure to recognize differences between review and inspection• Lack of meaningful markers and metrics to establish quality• Lack of appreciation for how rhetorical strategy varies by document genre• Lack of understanding of situational reading behavior
Failure to recognize differences between review and inspectionSymptoms:• “word smithing” even when requested to avoid doing so• 5 people with 5 suggestions how to rewrite one sentence• Starting on page one, line one, word one and reading document in serial progression
Lack of meaningful markers and metrics to establish qualitySymptoms:• Competing opinions about “what to do” or “how to state” in a document• Continually revisit a narrative in successive drafts• Work on a narrative until “take it away from me”• Use previous work (narratives or full documents) as benchmark to judge current work
Lack of appreciation for how rhetorical strategy varies by document genre, document section, audience situationSymptoms:• All feet will fit one shoe: – Repurposing without account for audience, genre, or section intention – “the template is king…long live the king!!” – “well when I was writing manuscripts we…..”• Well this does not work for me
Lack of understanding of situational reading behaviorSymptoms:• If we write it…..they will read it• I am an SME and that means all SMEs like me read “just like I do”• I want documents written just like how I think/conduct science• Starting to review from page 1, line 1, and reading straight through to page n
Reviewer discipline• Right people wrong time
Reviewer discipline• Right people wrong time• It’s gotta be done my way
Reviewer discipline• Right people wrong time• It’s gotta be done my way• Misapply review focus
In SummaryRecognizing non-productive review practices shouldbe an object of focus for more organizations• Know where you want to look• Address root cause not just symptoms• For CAPA: take small bites of the apple• Start measuring and reportingChanging non-productive practices not an easy matterbecause of deeply in-grained learned behavior