12. Resources (listed in order of appearance)

European Union

1. EU Clinical Trial Regulation (EU CTR) 536/2014

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02014R0536-20220131  

2. EMA- Questions and Answers Document Regulation (EU) 536/2014

https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-10_en  

3. EU Clinical Trial Register

https://www.clinicaltrialsregister.eu/ctr-search/search   

4. EMA Organisation Management System (OMS)

https://spor.ema.europa.eu/omswi/#/ 

5. EMA- Clinical Trials Information System (CTIS): online training modules

https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/clinical-trials-human-medicines/clinical-trials-information-system-training-and-support/clinical-trials-information-system-ctis-online-training-modules  

6. EMA CTIS Evaluation Timelines

https://www.ema.europa.eu/en/documents/other/clinical-trial-information-system-ctis-evaluation-timelines_en.pdf  

7. EMA Guideline on Computerised Systems and Electronic data in Clinical Trials

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf  

8. EMA- Recommendation Paper on Decentralized elements in clinical trial

https://health.ec.europa.eu/latest-updates/recommendation-paper-decentralised-elements-clinical-trials-2022-12-14_en  

9. EMA Serious Breaches Guidance_30 June 2023

https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-notification-serious-breaches-regulation-eu-no-5362014-or-clinical-trial-protocol_en.pdf 

10. EMA- Appendix IIIb- Information to be submitted with a notification of a serious breach.

https://view.officeapps.live.com/op/view.aspx?src=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Ftemplate-form%2Fappendix-iii-b-information-be-submitted-notification-serious-breach-guideline-notification-serious-breaches-regulation-eu-no-5362014-or-clinical-trial-protocol_en.doc&wdOrigin=BROWSELINK

11. European Commission- Customs clearance documents and procedures

https://trade.ec.europa.eu/access-to-markets/en/content/customs-clearance-documents-and-procedures 

12. EudraVigilance Clinical Trial Module

https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/pharmacovigilance-research-and-development/eudravigilance 

13. EFPIA Code of Practice

https://www.efpia.eu/relationships-code/the-efpia-code/

14. EMA- Paediatric Investigations Plan

https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/paediatric-medicines-research-and-development/paediatric-investigation-plans/paediatric-investigation-plans-submitting-documents 

15. European Judicial Network- Parental Responsibility-child custody and contacts rights

https://e-justice.europa.eu/content_parental_responsibility-302-be-en.do?init=true  

16. EMA- European Network of Paediatric Research at the European Medicines Agency- Informed Consent for Paediatric Trials in Europe 2015 (revision 06 June 2023)

https://www.ema.europa.eu/en/documents/other/informed-consent-paediatric-clinical-trials-europe-2015_en.pdf

17. General Data Protection Regulation (GDPR) 2016/679

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32016R0679 

18. ICH E6 (R2)- Good Clinical Practice

https://www.ich.org/page/efficacy-guidelines

19. EU’s Standard Contractual Clauses 

https://ec.europa.eu/info/law/law-topic/data-protection/international-dimension-data-protection/standard-contractual-clauses-scc_en

20. EU Commission- Commercial sector: adequacy decision on the EU-US Data Privacy Framework

https://commission.europa.eu/law/law-topic/data-protection/international-dimension-data-protection/eu-us-data-transfers_en

Poland

1. Act on Clinical Trials of Medicinal Products for Human Use - March 2023

https://orka.sejm.gov.pl/proc9.nsf/ustawy/2843_u.htm 

2. Pharmaceutical Law 2001 - Consolidated version 

https://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20220002301 

3. Medical and Dental Professions Act_05 Dec 1996

https://lexlege.pl/ustawa-o-zawodach-lekarza-i-lekarza-dentysty/rozdzial-4-eksperyment-medyczny/5723/#ustawa-o-zawodach-lekarza-i-lekarza-dentysty/,ustawa-o-zawodach-lekarza-i-lekarza-dentysty/ 

4. The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL)

https://www.urpl.gov.pl/pl  

5. URPL Clinical Trials Fees- Payment Details

https://urpl.gov.pl/pl/op%C5%82aty 

6. URPL Clinical Trials Fees

https://urpl.gov.pl/pl/op%C5%82aty 

7. Supreme Bioethics Committee (Naczelna Komisja Bioetyczna- NKB-)

https://nkb.gov.pl/nkb/naczelna-komisja-bioetyczna/naczelna-komisja-bioetyczna/2149,NACZELNA-KOMISJA-BIOETYCZNA.html 

8. Medical Research Agency

https://abm.gov.pl/ 

9. Ombudsman for Patients’ Rights

https://www.gov.pl/web/rpp/informacje-dla-sponsorow-badan-klinicznych#p2

10. Medical Research Agency - ICF Templates

https://abm.gov.pl/pl/aktualnosci/2513,Aktualizacja-wzorow-formularzy-swiadomej-zgody-ICF-dla-uczestnikow-doroslych-i-m.html 

11. List of Bioethics Committees authorized to carry out evaluation of a clinical trial.

https://nkb.gov.pl/nkb/lista-komisji-bioetycznych/2249,Lista-komisji-bioetycznych-uprawnionych-do-dokonywania-oceny-etycznej-badania-kl.html 

12. Government page - Import Licenses

https://www.gov.pl/web/gif/wytwarzanie-i-import-produktow-leczniczych