1. US Department of HHS, FDA, CDER, CBER. Guidance for Industry. ICH E8(R1) General considerations for clinical trials. FDA, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e8r1-general-considerations-clinical-studies (2019, accessed 10 June 2021).
2. Enhancing clinical evidence by proactively building quality into clinical trials
3. US Department of HHS, FDA, CDER, CBER. E3 Structure and content of clinical study reports: questions and answers (R1). FDA, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e3-structure-and-content-clinical-study-reports-questions-and-answers-r1 (2013, accessed 10 June 2021).
4. US Department of HHS, FDA, CDER, CBER. E6(R2) Good clinical practice: integrated addendum to ICH E6(R1), https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1 (2018, accessed 10 June 2021).
5. US Department of HHS, FDA, CDER, CBER. Oversight of clinical investigations—a risk-based approach to monitoring. FDA, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oversight-clinical-investigations-risk-based-approach-monitoring (2013, accessed 10 June 2021).