1. Declaration of Helsinki.https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
2. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Accessed 30 April 2024 https://www.ich.org/page/ich-guidelines
3. European Medicines Agency Scientific Guidelines. Accessed 30 April 2024 https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/quality-guidelines
4. European Medicines Agency.Guideline on strategies to identify and mitigate risks for first‐in‐human and early clinical trials with investigational medicinal products. Accessed 30 April 2024 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-strategies-identify-and-mitigate-risks-first-human-and-early-clinical-trials-investigational-medicinal-products-revision-1_en.pdf
5. Medicines Health and Regulatory Agency Clinical Trials Guidelines.https://www.gov.uk/guidance/clinical-trials-for-medicines-apply-for-authorisation-in-the-uk