12. Resources (listed in descending order of precedence)

Regulations

1. EU Clinical Trial Regulation 2014/536: https://health.ec.europa.eu/system/files/2016-11/reg_2014_536_en_0.pdf
2. General Data Protection Regulation (GDPR): https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32016R0679&from=EN 

Directives

1. Directive 2001/20/EC: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32001L0083&from=en
2. Directive 2001/83/EC: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32001L0083&from=en

Guidelines

1. EMA Recommendation paper on the use of Decentralized elements in Clinical Trials: https://health.ec.europa.eu/latest-updates/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en
2. EMA Guideline on Computerized Systems and electronic data in clinical trials: Guideline on computerised systems and electronic data in clinical trials (europa.eu)
3. EMA Guideline on the responsibilities of the sponsor with regard to handling and shipping of IMP for human use in accordance with GCP and GMP: https://health.ec.europa.eu/system/files/2022-12/guideline_handling-shipping_investigational-mp_en.pdf
4. Guideline- Auxiliary Medicinal Products in Clinical Trials: https://health.ec.europa.eu/system/files/2017-08/2017_06_28_recommendation_on_axmps_0.pdf
5. EMA Guidance document how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS):  
   https://accelerating-clinical-trials.europa.eu/system/files/2023-07/guidance-document-how-approach-protection-personal-data-commercially-confidential-information-while_.pdf
   

Other

A. EMA (General)

1. EMA- Research & Development page: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development 
2. EMA CTIS: https://euclinicaltrials.eu/home
3. EMA Clinical Trials Regulation: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation
4. EMA Eudralex Volume 10: https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-10_en
5. EMA GCP Q&As: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-clinical-practice/qa-good-clinical-practice-gcp 
6. EMA Q&As EUCTR: https://health.ec.europa.eu/system/files/2023-12/regulation5362014_qa_en_0.pdf 

B. ACT EU

1. EMA Act EU: https://www.ema.europa.eu/en/events/act-eu-multi-stakeholder-meeting-decentralised-clinical-trials

C. CTIS

1. EMA CTIS Presentation: https://www.ema.europa.eu/en/documents/presentation/presentation_en-0.pdf
2. EMA: Clinical Trial Information System (CTIS): online training modules: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-ctis-online-modular-training-programme
3. EMA Step-by-step guide: How to manage a clinical trial Module 5 https://www.ema.europa.eu/en/documents/other/step-step-guide-how-manage-ct-ctis-training-programme-module-05_en.pdf
4. EMA CTIS- Sponsor Handbook: https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-sponsor-handbook_.pdf
5. EMA Paediatric Investigation Plan: https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/paediatric-medicines-research-and-development/paediatric-investigation-plans

D. Clinical Trials Register

1. https://www.clinicaltrialsregister.eu
2. https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en 

E. Ethics Committees

1. http://www.eurecnet.org/index.html

F. Miscellaneous

1. EU: Q&A on the interplay between the CTR and the GDPR: https://health.ec.europa.eu/system/files/2019-04/qa_clinicaltrials_gdpr_en_0.pdf 
2. EFPIA Code: https://www.efpia.eu/relationships-code/the-efpia-code/