12. Resources (listed in descending order of precedence)

Europe Union (EU)

EU Clinical Trial Regulation (EU CTR) 536/2014

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

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

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

EU Clinical Trial Register

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

EMA Organisation Management System (OMS)

https://spor.ema.europa.eu/omswi/#/ 

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  

EMA CTIS Evaluation Timelines

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

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 

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  

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 

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

European Commission- Customs clearance documents and procedures

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

EFPIA Code of Practice

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

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

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

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

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

EUDRALEX Volume 10

https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-10_en#set-of-documents-applicable-to-clinical-trials-authorised-under-regulation-eu-no-5362014  

EU Regulation No. 910/2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (eIDAS)

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv:OJ.L_.2014.257.01.0073.01.ENG 

Regulation (EU) 2016/679- General Data Protection Regulation- (GDPR)

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

France

Agence nationale de sécurité du médicament et des produits de santé (“ANSM”)

https://ansm.sante.fr/ 

ANSM: Clinical Trials: Procedures for the constitution and processing of application under the European Clinical Trial Regulation on medicinal products

https://ansm.sante.fr/page/essais-cliniques-procedures-pour-la-constitution-et-le-traitement-des-demandes-relevant-du-reglement-europeen-sur-les-essais-cliniques-de-medicament 

Comités de Protection des Personnes (“CPP”)

https://www.iledefrance.ars.sante.fr/comites-de-protection-des-personnes-cpp

Public Health Code (CSP)

https://www.legifrance.gouv.fr/codes/texte_lc/LEGITEXT000006072665

Ministry of Health- Documents expected in France for the filling of part II of the CTA (v3_17 Aug 2023)

https://sante.gouv.fr/IMG/pdf/cnriph_documents_attendus_en_france_concernant_la_partie_ii_de_cta_2023_08_17.pdf 

Shared Directory of Professional Involved in the Health System (RPPS)

https://esante.gouv.fr/produits-services/repertoire-rpps 

Insurance Code

https://www.legifrance.gouv.fr/codes/texte_lc/LEGITEXT000006073984/2024-04-04/  

Related to Data Protection:

CNIL

https://www.cnil.fr/fr/recherches-dans-le-domaine-de-la-sante-la-cnil-adopte-de-nouvelles-mesures-de-simplification

Law No. 78-17 of 6 January 1978 relating to data processing, files and civil liberties

https://www.legifrance.gouv.fr/loda/id/JORFTEXT000000886460

CNOM (National Council of the Order of Physicians)

https://www.conseil-national.medecin.fr/lordre-medecins/conseil-national-lordre/relations-lindustrie-pharmaceutique