Presentation Slides For Agile Review
- 1. The Concept of Agile ReviewAgile methodologies mostly applied to software developmentPractices extended by Nokia to the authoring/reviewing of technical documentation 1
- 2. The ApproachNokia recognized traditional document approaches primarily rely on inspection not review to verify the quality of the documentation Approach—get people involved in the documentation process earlier to ensure communication qualitycalendar time efficiencycommitment2
- 3. Agile ReviewAgile review concentrates only on the critical document content that fulfills a narrowly defined purpose Review focus at the exclusion of the rest of the document content3
- 4. Agile Review Driven by extension of Pareto’s 80/20 rule80% of meaning derived from 20% of document content4
- 5. Vilfredo ParetoApplying Pareto’s 80/20 Rule: 80 percent of the critical information/key messages comes from only 20 percent of the volume of information submitted in any individual report or set of reports Information in reports is often “noise” that can keep the reader from finding the “signal”5
- 6. Agile Review Driven by extension of Pareto’s 80/20 rule80% of meaning derived from 20% of document contentCentered on satisficing document user6
- 7. In CSRs and summary-level submission documents the majority of “words” are merely descriptive text that obscure meaning7
- 8. In protocols the majority of “words” are merely descriptive text that obscure instruction regarding agency and actor8
- 9. Apply Agile Review Method toClinical DocumentationLimited time applied to the task of reviewPeel document like an onion (review in layers of detail)Non-linear reading of the documentInvolves task of skim and scan to review the document9
- 10. 10Review Focus: Architecture of the Argument
- 11. 11Review Focus: Logic Trail ClarityGoal (Purpose/Hypothesis)ObjectivesVariables / StandardsResultsConclusions (Discussion)Significance (The so what we learned )
- 12. Review Focus: UsabilityReduce ambiguityIncrease brevityImprove reader acquisition timeComprehensionRecall12
- 13. Review Focus: Quality of ArgumentClaim:The key message or conclusion drawn from the dataData:Does the document draw a red line to supporting data?Warrant: Does document define principle that justifies stated interpretation of the data to support the claim we are making? 13
- 14. Review Focus: Topic Sentence Review Read only the first sentence of every paragraphConfirm first sentence is topic sentenceTest “flow”14
- 15. Review Focus: Key Term/Word Search In a CSRKey assessment terms for primary and secondary endpointsKey safety terms15
- 16. Review Focus: Summary Document Quality to Synthesize Messages/Argument What efficacy and safety information contributes to the assessment of clinical pharmacology and biopharm data?How does the PK of XXX in healthy volunteers compare to that in patients?How do PK parameters change with time following chronic dosing?What intrinsic factors influence exposure and/or response and what is impact of any difference in exposure on PD? 16
- 17. Review Focus: Key Term/Word Search In a ProtocolKey conceptsModal verbs17
- 18. Modal VerbsThe word must is used to indicate mandatory requirementsThe word should is used to indicate that among several possibilities one is recommendedThe word may is used to indicate a course of action permissible within the limits of a standardThe use of the word will is used when making statements of fact. The word shall is used to indicate mandatory requirements strictly to be followed in order to conform to the standard18
- 19. Concept of Agile ReviewAgile review grew out of the pain inflicted by real-life project experiences Address the challenges and limitations of traditional document reviews—both in terms of overall philosophy as well as specific practices19
- 20. Benefits of Agile ReviewEconomyInvestment of reviewer time on taskReduction of reviewersCommunication qualityCentered on what counts—“meaning”“usability”20
- 21. “The reasonable man adapts himself to the world; the unreasonable one persists in trying to adapt the world to himself. Therefore all progress depends on the unreasonable man.”---- George Bernard Shaw21