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    12. Resources (listed in descending order of precedence)
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    Contents

    12. Resources (listed in descending order of precedence)

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    Article summary

    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. EFPIA Code of Practice

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

    13. 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

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

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

    15. 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  

    Germany 

    1. Federal Ministry of Health / Bundesministerium für Gesundheit

    https://www.bundesgesundheitsministerium.de/   

    2. Paul-Ehrlich-Institut (“PEI”)

    https://www.pei.de/EN/home/home-node.html 

    3. Bundesinstitut für Arzneimittel und Medizinprodukte (“BfArM”)

    https://www.bfarm.de/EN/Home/_node.html  

    4. Medicinal Products Act (AMG)

    https://www.gesetze-im-internet.de/englisch_amg/  

    5. Clinical Trials Evaluation Procedure Ordinance (KPBV)

    https://www.gesetze-im-internet.de/kpbv/ 

    6. List of EC registered in accordance with Section 41a AMG

    https://www.bfarm.de/SharedDocs/Downloads/DE/Arzneimittel/KlinischePruefung/Liste.pdf?__blob=publicationFile 

    7. The Central Customs Authority (ZOLL)

    https://www.zoll.de/EN/Businesses/Movement-of-goods/Import/Restrictions/Goods/Medicinal-products-and-narcotics/Medicinal-products/medicinal-products.htm 

    8. BfArM- Manufacturing authorization and import authorization page

    https://www.bfarm.de/EN/Medicinal-products/_FAQ/Clinical-trials/Pharmaceutical-quality/Manufacturing-import-authorisation/faq-liste.html?nn=880414  

    9. BfArM- Non-Interventional studies

    https://www.bfarm.de/DE/Arzneimittel/Klinische-Pruefung/Nichtinterventionelle-Studien/_node.html   

    10. The Federal Office for Economic Affairs and Export Control

    https://www.bafa.de/SharedDocs/Downloads/EN/Foreign_Trade/ec_awareness_academia.html?nn=1444548 

    11. Germany Clinical Trials Register (DRKS)

    https://www.bfarm.de/EN/BfArM/Tasks/German-Clinical-Trials-Register/_node.html 

    12. The Association of Medical Ethics Committees (AKEK)

    https://www.akek.de/en/ 

    13. AKEK- Training for Investigators

    https://www.akek.de/en/curriculare-fortbildungen/ 

    14. AKEK- Clinical Trials with medicinal products (including templates)

    https://www.akek.de/en/arzneimittelgesetz-amg/  

    15. The German Ordinance on the Procedure for Cooperation between the Higher Federal Authorities and the Registered Ethics Committees in the evaluation of applications for approval of clinical trials with Medicinal Products for Human use (KPBV)

    https://www.gesetze-im-internet.de/kpbv/index.html   

    16. Appendix 1- Application related declaration of personal and financial interest

    https://www.gesetze-im-internet.de/kpbv/anlage_1.html 

    17. Appendix 2- Annual Declaration of Financial Interests

    https://www.gesetze-im-internet.de/kpbv/anlage_2.html 

    18. Bundesamt für Strahlenschutz - BfS

    https://www.bfs.de/DE/themen/ion/anwendung-medizin/forschung/forschung_node.html 

    19. Radiation Protection Act

    https://www.gesetze-im-internet.de/strlschg/ 

    20. Germany- Data Protection Act

    https://www.gesetze-im-internet.de/englisch_bdsg/

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