1. 1. US Department of Health and Human Services Food and Drug Administration. Food and Drugs, 21 CFR §56 (2021). Available at https://www.ecfr.gov/
2. 2. European Medicines Agency (EMA). Guideline for good clinical practice E6(R2). 2016, p.28, 30. Available at https://www.ema.europa.eu/en/documents/scientific-guideline/ich-e-6-r2-guideline-good-clinical-practice-step-5_en.pdf
3. 3. US Department of Health and Human Services Food and Drug Administration. Guidance for Industry: Electronic Source Data in Clinical Investigations. 2013, p.6, 48, Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/electronic-source-data-clinical-investigations
4. 4. European Medicines Agency (EMA). Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials. 2010. p.7, 9, 10 Available at https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/reflection-paper-expectations-electronic-source-data-data-transcribed-electronic-data-collection_en.pdf
5. 5. US Department of Health and Human Services Food and Drug Administration. Guidance for industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. Dec 2009, p.27. Available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims