Handbook
References
Everything cited in the written chapters, in one place. References for the nine outline chapters will be added when those chapters are written.
Standards and guidance
- CDISC. Analysis Data Model Implementation Guide (ADaMIG) version 1.3. www.cdisc.org ↗Cited in Ch 06
- CDISC. Study Data Tabulation Model Implementation Guide (SDTMIG) version 3.4. www.cdisc.org ↗Cited in Ch 06
- ICH. E6(R3) Guideline for Good Clinical Practice. International Council for Harmonisation; 2025. www.ich.org ↗Cited in Ch 04, Ch 06, Ch 08
- ICH. E9(R1) Addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. Step 4, 2019. database.ich.org ↗Cited in Ch 06
- ISO. ISO 31000:2018 Risk management: Guidelines. International Organization for Standardization; 2018. www.iso.org ↗Cited in Ch 08
- U.S. Food and Drug Administration. Study Data Technical Conformance Guide: Technical Specifications Document. www.fda.gov ↗Cited in Ch 06
Books and papers
- Brooks FP. The Mythical Man-Month: Essays on Software Engineering. Anniversary ed. Addison-Wesley; 1995.Cited in Ch 04
- Buehler R, Griffin D, Ross M. Exploring the "planning fallacy": why people underestimate their task completion times. Journal of Personality and Social Psychology. 1994;67(3):366-381.Cited in Ch 04
- Edmondson A. Psychological safety and learning behavior in work teams. Administrative Science Quarterly. 1999;44(2):350-383.Cited in Ch 08
- Goldratt EM. Critical Chain. North River Press; 1997.Cited in Ch 04, Ch 06, Ch 08
- Hubbard DW. The Failure of Risk Management: Why It's Broken and How to Fix It. 2nd ed. Wiley; 2020.Cited in Ch 08
- Kahneman D, Tversky A. Intuitive prediction: biases and corrective procedures. TIMS Studies in Management Science. 1979;12:313-327.Cited in Ch 04
- Reinertsen DG. The Principles of Product Development Flow: Second Generation Lean Product Development. Celeritas Publishing; 2009.Cited in Ch 04