Ethic and Legal Issues

In this section you will find relevant documents to guide you on ethical and legal issues in the RD field

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Recommendation paper on decentralised elements in clinical trials

Published by EMA

Decentralised Clinical Trials

Recommendations that aim to facilitate the conduct of decentralised clinical trials (DCTs) while safeguarding the rights and well-being of participants as well as the robustness and reliability of the data collected

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Guideline on computerised systems and electronic data in clinical trials

Published by EMA

Computerised systems, electronic data, validation, audit trail, user management, security, electronic clinical outcome assessment (eCOA), interactive response technology (IRT), case report form (CRF), electronic signatures, artificial intelligence (AI)

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DIRECTIVE 2004/9/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on the Inspection and Verification of Good Laboratory Practice (GLP).

Published by Official Journal of the European Union

Chemical SubstancesChemical UseDirectiveEthical Use of AnimalsGood Laboratory Practice (GLP)

This Directive is to verification of the organisational processes and the conditions under which laboratory studies are planned, performed, recorded and reported for the non-clinical testing, carried out in accordance with the rules and regulations, of all chemicals in order to assess the effect of such products on man, animals and the environment. 

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EU Guidance on Preclinical Pharmacological and Toxicological Testing of Vaccines (CPMP/SWP/465/95).

Published by The European Agency for the Evaluation of Medicinal Products, EMA

Animal ModelsEMAGuidelinePreclinical TestingToxicityVaccine

This is a note for guidance  on the preclinical evaluation of new vaccine products including combined vaccines, vaccines are those containing antigens not yet described in European Pharmacopoeia monographs or in WHO requirements and vaccines containing live organisms. It indicated the suitable animal models and ethics issues for vaccine preclinical testing. 

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DIRECTIVE 2004/10/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004  on the Harmonisation of Laws, Regulations and Administrative Provisions Relating to the Application of the Principles of Good Laboratory Practice and the Verification of Their Applications for Tests on Chemical Substances (Codified Version)

Published by Official Journal of the European Union

Chemical SubstancesChemical UseDirectiveEthical Use of AnimalsGood Laboratory Practice (GLP)

This directive indicates harmonisation of laws, regulations and administrative provisions relating to the application of principles of good laboratory practice and the verification of their applications for tests on chemical substances. 

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