{ "article": { "LEGIARTI000049986894": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1125-20", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2024-07-14" } }, "META_COMMUN": { "ID": "LEGIARTI000049986894", "URL": "article/LEGI/ARTI/00/00/49/98/68/LEGIARTI000049986894.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049967627", "@num": "6", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "MODIFIE", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000030232709", "@num": "R1125-20-1", "#text": "Code de la santé publique - art. R1125-20-1 (T)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049974911", "@num": "R1127-20", "#text": "Code de la santé publique - art. R1127-20 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000049975834", "@fin": "2999-01-01", "#text": "Section 2 : Assurance des promoteurs d'une investigation clinique", "@debut": "2024-07-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000049975818", "@fin": "2999-01-01", "#text": "Chapitre V : Dispositions particulières relatives aux investigations cliniques", "@debut": "2024-07-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132378", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-12-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000030232707", "@fin": "2017-05-11", "@num": "R1125-20", "@etat": "MODIFIE", "@debut": "2015-02-14", "@origine": "LEGI" } }, { "@etat": "TRANSFERE", "LIEN_ART": { "@id": "LEGIARTI000034697089", "@fin": "2024-07-14", "@num": "R1125-20", "@etat": "TRANSFERE", "@debut": "2017-05-11", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000049986894", "@fin": "2999-01-01", "@num": "R1125-20", "@etat": "VIGUEUR", "@debut": "2024-07-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les contrats d'assurance ne peuvent pas stipuler des garanties d'un montant inférieur à :

1° 1 000 000 euros par victime ;

2° 6 000 000 euros par protocole d'investigation clinique ;

3° 10 000 000 euros pour l'ensemble des réclamations présentées pendant une année d'assurance au titre de plusieurs protocoles d'investigations cliniques.

" } }, "LEGIARTI000030232709": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1125-20-1", "ETAT": "TRANSFERE", "TYPE": "AUTONOME", "DATE_FIN": "2024-07-14", "DATE_DEBUT": "2015-02-14" } }, "META_COMMUN": { "ID": "LEGIARTI000030232709", "URL": "article/LEGI/ARTI/00/00/30/23/27/LEGIARTI000030232709.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000030231463", "@num": "3", "#text": "DÉCRET n°2015-155 du 11 février 2015 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000030227232", "@nortexte": "MENR1418251D", "@numtexte": "2015-155", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2015-02-11" }, { "@id": "LEGIARTI000049967623", "@num": "4", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 4", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "TRANSFERE", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000049986909", "@num": "R1125-17", "#text": "Code de la santé publique - art. R1125-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986894", "@num": "R1125-20", "#text": "Code de la santé publique - art. R1125-20 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975007", "@num": "R1127-20-1", "#text": "Code de la santé publique - art. R1127-20-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000030232693", "@fin": "2999-01-01", "#text": "Sous-section 1 : Définitions et conditions particulières", "@debut": "2015-02-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000030232691", "@fin": "2016-11-18", "#text": "Section 3 : Dispositions particulières aux recherches biomédicales menées dans le cadre de l'assistance médicale à la procréation", "@debut": "2015-02-14" }, { "@id": "LEGISCTA000033418470", "@fin": "2022-01-01", "#text": "Section 3 : Dispositions particulières aux recherches menées dans le cadre de la procréation médicalement assistée", "@debut": "2016-11-18" }, { "@id": "LEGISCTA000044968709", "@fin": "2999-01-01", "#text": "Section 3 : Dispositions particulières aux recherches menées dans le cadre de l'assistance médicale à la procréation", "@debut": "2022-01-01" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006178474", "@fin": "2024-07-14", "#text": "Chapitre V : Dispositions particulières à certaines recherches", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000049986856", "@fin": "2999-01-01", "#text": "Chapitre VII : Dispositions particulières à certaines recherches", "@debut": "2024-07-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132378", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-12-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "TRANSFERE", "LIEN_ART": { "@id": "LEGIARTI000030232709", "@fin": "2024-07-14", "@num": "R1125-20-1", "@etat": "TRANSFERE", "@debut": "2015-02-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le silence gardé à l'expiration du délai d'instruction de la demande d'autorisation mentionnée à l'article R. 1125-17 vaut rejet.
\n
Le silence gardé à l'expiration du délai d'instruction de la demande de modification substantielle mentionnée à l'article R. 1125-20 vaut également rejet.
\n
\n
\n
\n

" } }, "LEGIARTI000049967627": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "6", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000049967627", "URL": "article/LEGI/ARTI/00/00/49/96/76/LEGIARTI000049967627.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000049975818", "#text": "Code de la santé publique - Chapitre V : Dispositions particulières relativ... (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGISCTA000049975844", "#text": "Code de la santé publique - Chapitre VI : Dispositions particulières relati... 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R1125-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986957", "@num": "R1125-10", "#text": "Code de la santé publique - art. R1125-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986951", "@num": "R1125-11", "#text": "Code de la santé publique - art. R1125-11 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986945", "@num": "R1125-12", "#text": "Code de la santé publique - art. R1125-12 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986937", "@num": "R1125-13", "#text": "Code de la santé publique - art. R1125-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986928", "@num": "R1125-14", "#text": "Code de la santé publique - art. R1125-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986924", "@num": "R1125-15", "#text": "Code de la santé publique - art. R1125-15 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986914", "@num": "R1125-16", "#text": "Code de la santé publique - art. R1125-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986909", "@num": "R1125-17", "#text": "Code de la santé publique - art. 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A créé les dispositions suivantes :

- Code de la santé publique
\n Art. R1125-32\n
\n

\n
\n
A modifié les dispositions suivantes :

- Code de la santé publique
Art. R1125-1, Art. R1125-2, Art. R1125-3, Art. R1125-4, Art. R1125-5, Art. R1125-6, Art. R1125-7, Art. R1125-8, Art. R1125-9, Art. R1125-10, Art. R1125-11, Art. R1125-12, Art. R1125-13, Art. R1125-14, Art. R1125-15, Art. R1125-16, Art. R1125-17, Art. R1125-18, Art. R1125-19, Art. R1125-20, Art. R1125-21, Art. R1125-22, Art. R1125-23, Art. R1125-24, Art. R1125-25, Art. R1125-26\n
\n

\n
\n
A créé les dispositions suivantes :

- Code de la santé publique
\n Art. R1125-31\n
\n

\n
\n
A créé les dispositions suivantes :

- Code de la santé publique
\n Sct. Chapitre V : Dispositions particulières relatives aux investigations cliniques, Sct. Section 1 : Dispositions diverses, Sct. Section 2 : Evaluation par les comités de protection des personnes, Sct. Sous-section 1 : Désignation du comité, Sct. Sous-section 2 : Procédure relative aux demandes initiales d'investigations cliniques, Sct. Sous-section 3 : Demande de modification substantielle, Sct. Sous-section 4 : Procédure de réexamen, Sct. Sous-section 5 : Procédure accélérée, Sct. Section 2 : Assurance des promoteurs d'une investigation clinique, Sct. Section 3 : Conditions d'autorisation de certains lieux d'investigation clinique, Sct. Section 4 : Dispositions financières, Sct. Section 5 : Suspension, interdiction et fin de l'investigation clinique, Sct. Section 6 : Fichier national des personnes qui se prêtent à des investigations cliniques, Sct. Chapitre VI : Dispositions particulières relatives aux études des performances, Sct. Section 1 : Dispositions diverses, Art. R1126-1, Art. R1126-2, Sct. Section 2 : Evaluation par les comités de protection des personnes, Sct. Sous-section 1 : Désignation du comité, Art. R1126-3, Art. R1126-4, Art. R1126-5, Sct. Sous-section 2 : Procédure relative aux demandes initiales d'études des performances, Art. R1126-6, Art. R1126-7, Art. R1126-8, Art. R1126-9, Art. R1126-10, Sct. Sous-section 3 : Demande de modification substantielle, Art. R1126-11, Art. R1126-12, Art. R1126-13, Sct. Sous-section 4 : Procédure de réexamen, Art. R1126-14, Art. R1126-15, Sct. Sous-section 5 : Procédure accélérée, Art. R1126-16, Sct. Section 2 : Assurance des promoteurs d'une étude des performances, Art. R1126-17, Art. R1126-18, Art. R1126-19, Art. R1126-20, Art. R1126-21, Art. R1126-22, Art. R1126-23, Sct. Section 3 : Conditions d'autorisation de certains lieux d'étude des performances, Art. R1126-24, Art. R1126-25, Art. R1126-26, Art. R1126-27, Art. R1126-28, Sct. Section 4 : Dispositions financières, Art. R1126-29, Art. R1126-30, Sct. Section 5 : Suspension, interdiction et fin de l'étude des performances, Art. R1126-31, Sct. Section 6 : Fichier national des personnes qui se prêtent à une étude des performances, Art. R1126-32\n
\n

\n
\n
A créé les dispositions suivantes :

- Code de la santé publique
Art. R1125-24, Art. R1125-25, Art. R1125-26, Art. R1125-27, Art. R1125-28\n
\n

\n
\n
A créé les dispositions suivantes :

- Code de la santé publique
\n Art. R1125-29, Art. R1125-30\n
\n

\n
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Article R1125-20 AUTONOME VIGUEUR, en vigueur depuis le 14/07/2024 (Code de la santé publique)