{"id":4643,"date":"2018-04-23T10:54:06","date_gmt":"2018-04-23T10:54:06","guid":{"rendered":"http:\/\/imas12.es\/en\/?page_id=4643"},"modified":"2020-03-02T12:15:29","modified_gmt":"2020-03-02T12:15:29","slug":"ecrmp","status":"publish","type":"page","link":"https:\/\/imas12.es\/en\/ecrmp\/","title":{"rendered":"Ethic Committee for Research with medicinal products (ECRmp)"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row][vc_column][vc_tta_tabs style=&#8221;modern&#8221; color=&#8221;orange&#8221; active_section=&#8221;1&#8243;][vc_tta_section title=&#8221;Presentation&#8221; tab_id=&#8221;1524479253922-db3f7d63-9113&#8243;][vc_column_text]<\/p>\n<p>&nbsp;<\/p>\n<p>On 13 January 2016, the new Royal Decree 1090\/2015 came into effect, regulating clinical trials with drugs, the Research Ethics Committees with medicines and the Spanish Registry of Clinical Studies. This royal decree seeks to adapt Spanish legislation to make viable the current and future application of Regulation (EU) No. 536\/2014 and to develop those aspects that the regulation leaves to national legislation, including the\u00a0<strong>Ethic Committee for Research with medicinal products<\/strong>. Several aspects are introduced that involve a novelty with respect to the Committees, starting with the denomination itself as the Research Ethics Committees with medicinal products (ECR). In addition, it is worth highlighting the recognition of the integration of the ECR in the development of the Law 14\/2007, of 3 July on biomedical research.<\/p>\n<p>All the documentation referring to this new legislation is posted on the\u00a0<strong><a href=\"https:\/\/www.aemps.gob.es\/investigacionClinica\/medicamentos\/ensayosClinicos.htm\">website of the Spanish Agency for Medicines and Medical Devices<\/a><\/strong>.<\/p>\n<p>&nbsp;<\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;ECR Composition&#8221; tab_id=&#8221;1524479253944-bca6f311-f4ad&#8221;][vc_custom_heading text=&#8221;ECRmp Composition (Spanish)&#8221; font_container=&#8221;tag:h5|text_align:left&#8221; use_theme_fonts=&#8221;yes&#8221;][vc_column_text]<\/p>\n<ul>\n<li style=\"list-style-type: none\">\n<ul>\n<li>Presidenta: Dra. M\u00aa del Puy Goyache Go\u00f1i \u2014 Farmac\u00e9utico Adjunto de Farmacia Hospitalaria<\/li>\n<li>Vicepresidente: Dr. Luis Manuel Manso S\u00e1nchez\u2014 Adjunto de Oncolog\u00eda<\/li>\n<li>Vocales:\n<ul>\n<li>Dr. Jorge Adeva Alfonso &#8211; Medico Oncolog\u00eda<\/li>\n<li>D\u00aa M\u00aa Luisa Albelda de la Haza &#8211;\u00a0Licenciada Derecho<\/li>\n<li>Sra. Sagrario Alegre Alonso &#8211;\u00a0Coordinadora AECC<\/li>\n<li>Dr. Gonzalo Carre\u00f1o G\u00f3mez-Tarrago &#8211;\u00a0Medico Hematolog\u00eda<\/li>\n<li>Dra. Eva M\u00aa Carro D\u00edaz &#8211;\u00a0Comisi\u00f3n de Investigaci\u00f3n<\/li>\n<li>Dra. Mercedes Catal\u00e1n Gonz\u00e1lez &#8211;\u00a0Medico Intensivista<\/li>\n<li>Dra. Mar Espino Hern\u00e1ndez &#8211;\u00a0Pediatra de Atenci\u00f3n Primaria<\/li>\n<li>Sra. M\u00aa Pilar Hern\u00e1ndez Suarez &#8211;\u00a0Diplomado Universitario en Enfermer\u00eda.<\/li>\n<li>D\u00aa M\u00aa Teresa Garc\u00eda Morales \u2013 Ing. en Telecomunicaciones (delegada protecci\u00f3n de datos).<\/li>\n<li>Dra. Ana Jim\u00e9nez Ubieto &#8211;\u00a0M\u00e9dico Hematolog\u00eda<\/li>\n<li>D\u00aa Cristina Mart\u00edn-Arriscado Arroba &#8211;\u00a0Licenciada Estad\u00edstica<\/li>\n<li>Sr. Francisco Javier Mazuecos G\u00f3mez &#8211;\u00a0Trabajador Social Ayuntamiento Madrid<\/li>\n<li>Dr. Juli\u00e1n Palomino Doza &#8211;\u00a0Medico Cardiolog\u00eda<\/li>\n<li>Dra. Estela Paz Artal &#8211;\u00a0Medico Inmunolog\u00eda<\/li>\n<li>D\u00aa. Montserrat Pilas P\u00e9rez &#8211;\u00a0Diplomado Universitario en Enfermer\u00eda<\/li>\n<li>Dra. Mar\u00eda del Carmen Riesco Mart\u00ednez &#8211;\u00a0Medico Oncolog\u00eda<\/li>\n<li>Dra. Yolanda Rodr\u00edguez Gil &#8211;\u00a0M\u00e9dico Anatom\u00eda Patol\u00f3gica<\/li>\n<li>Dr. Roberto Rodr\u00edguez Jim\u00e9nez &#8211;\u00a0M\u00e9dico Psiquiatr\u00eda<\/li>\n<li>Dr. David S\u00e1nchez Guzm\u00e1n &#8211;\u00a0M\u00e9dico de Familia (Atenci\u00f3n Primaria)<\/li>\n<li>Dr. Rafael San Juan Garrido \u2013 M\u00e9dico Microbiolog\u00eda<\/li>\n<li>Dra. Raquel Sigu\u00edn G\u00f3mez \u2013 Farmac\u00e9utica Atenci\u00f3n Primaria<\/li>\n<li>Dra. Sarah\u00ed Elisabeth Valdez Acosta \u2013 Farmac\u00f3loga Cl\u00ednica (Secretaria T\u00e9cnica CEIm)<\/li>\n<li>Dra. Raquel Sope\u00f1a Sutil \u2013 M\u00e9dico Urolog\u00eda<\/li>\n<\/ul>\n<\/li>\n<li>Secretaria: Dra. Mar\u00eda Ugalde D\u00edez \u2014 Doctora en Ciencias Biol\u00f3gicas<\/li>\n<\/ul>\n<p>Versi\u00f3n: dic-2019<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Requirements&#8221; tab_id=&#8221;1524479420931-a87f175c-bc7f&#8221;][vc_column_text]<\/p>\n<ul>\n<li>Requirements for conducting clinical trials with medicinal products (<a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2020\/CEIm\/Ingles\/1.%20Requirements_clinical%20trials_h12o_February%202020.pdf\" target=\"_blank\" rel=\"noopener\">Document<\/a>)<\/li>\n<li>Requirements for conducting clinical research with a medical device (<a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2020\/CEIm\/Ingles\/2.%20Requirement%20Investigation%20with%20MD%20_h12o-february%202020.pdf\" target=\"_blank\" rel=\"noopener\">Document<\/a>)<\/li>\n<li>Requirements for requesting the evaluation of a relevant clinical trial modification (<a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2020\/CEIm\/Ingles\/3.%20Requirement%20Relevant%20Modification_h12o_Noviembre2020.pdf\" target=\"_blank\" rel=\"noopener\">Document<\/a>)<\/li>\n<li>Requirements for the studies follow-up to be submitted by the sponsor to CEIm (<a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2020\/CEIm\/Ingles\/4.%20Requirements%20follow-up_h12o_february%202020.pdf\" target=\"_blank\" rel=\"noopener\">Document<\/a>)<\/li>\n<li>Requirements for carrying out post-authorisation studies (PASs) with medicinal products (<a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2020\/CEIm\/Ingles\/5.%20Requirements%20EPAS_h12o_January%202020.pdf\" target=\"_blank\" rel=\"noopener\">Document<\/a>)<\/li>\n<li>Requirements for conducting Research Projects (<a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2020\/CEIm\/Ingles\/6.%20Requirements%20Clinical%20Reasearch%20Project_h12o-february%202020.pdf\" target=\"_blank\" rel=\"noopener\">Document<\/a>)<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Documentation models&#8221; tab_id=&#8221;1524479440518-e5a368cc-2957&#8243;][vc_column_text]<\/p>\n<ul>\n<li><a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2020\/CEIm\/Modelo%20HIP-CI%20proyecto%20inv%202020.doc\" target=\"_blank\" rel=\"noopener\">ICF model of research projects<\/a>.<\/li>\n<li><a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2020\/CEIm\/modelo%20HIP-CI%20muestras%20biologicas-rev%20feb2020.doc\" target=\"_blank\" rel=\"noopener\">ICF model for a project with biological samples<\/a>.<\/li>\n<li>Head of Department Compliance Templates:\n<ul>\n<li><a href=\"http:\/\/imas12.es\/wp-content\/uploads\/2017\/CEI\/CONFORMIDAD%20JEFE%20SERVICIO%20EPAS.doc\" target=\"_blank\" rel=\"noopener\">SOPs<\/a>.<\/li>\n<li><a href=\"http:\/\/imas12.es\/wp-content\/uploads\/2017\/CEI\/CONFORMIDAD%20JEFE%20SERVICIO%20PEAS.doc\" target=\"_blank\" rel=\"noopener\">Research Projects<\/a>.<\/li>\n<\/ul>\n<\/li>\n<li>Templates of PI commitments:\n<ul>\n<li><a href=\"http:\/\/imas12.es\/wp-content\/uploads\/2017\/CEI\/COMPROMISO%20INVEST_COLAB-proyectos.doc\" target=\"_blank\" rel=\"noopener\">Collaborators<\/a>.<\/li>\n<li><a href=\"http:\/\/imas12.es\/wp-content\/uploads\/2017\/CEI\/COMPROMISO%20DEL%20INVESTIGADOR-%20proyectos.doc\" target=\"_blank\" rel=\"noopener\">Principal Investigator<\/a>.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>For the download of the documentation templates related to clinical trials, you should go to the website of the\u00a0<a href=\"https:\/\/www.aemps.gob.es\/investigacionClinica\/medicamentos\/anexos-instrucciones-AEMPS-realiza-EC.htm\" target=\"_blank\" rel=\"noopener\">Spanish Medicines Agency<\/a>.<\/p>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Other documentation&#8221; tab_id=&#8221;1524479441213-c0995dde-0af5&#8243;][vc_column_text]<\/p>\n<ul>\n<li><a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2020\/CEIm\/PNT's%20version%202_febrero2020.pdf\" target=\"_blank\" rel=\"noopener\">SOPs (Feb 2020) (Spanish)<\/a><\/li>\n<li><a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2019\/CEIm\/MEMORIA_ACTIV_CEIm%202018.pdf\" target=\"_blank\" rel=\"noopener\">Activity Report 2018 (Spanish)<\/a><\/li>\n<li><a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2019\/CEIm\/MEMORIA%20ACTIVIDADES%20CEIm%202017.pdf\" target=\"_blank\" rel=\"noopener\">Activity Report 2017 (Spanish)<\/a><\/li>\n<li><a href=\"http:\/\/imas12.es\/wp-content\/uploads\/2017\/CEI\/MEMORIA%20ACTIVIDADES%20CEIC%202016%20Def.pdf\" target=\"_blank\" rel=\"noopener\">Activity Report 2016 (Spanish)<\/a><\/li>\n<li><a href=\"http:\/\/imas12.es\/wp-content\/uploads\/2016\/DocumentacionCEIC\/MEMORIA%20ACTIVIDAD%20CEIC%202015%20protegido.pdf\" target=\"_blank\" rel=\"noopener\">Activity Report 2015 (Spanish)<\/a><\/li>\n<li><a href=\"http:\/\/imas12.es\/wp-content\/uploads\/2016\/DocumentacionCEIC\/MEMORIA%20ACTIVIDAD%20CEIC%202014%20protegido.pdf\" target=\"_blank\" rel=\"noopener\">Activity Report 2014 (Spanish)<\/a><\/li>\n<li><a href=\"http:\/\/imas12.es\/wp-content\/uploads\/2016\/DocumentacionCEIC\/MEMORIA%20ACTIVIDAD%20CEIC%202013%20protegido.pdf\" target=\"_blank\" rel=\"noopener\">Activity Report 2013 (Spanish)<\/a><\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Calendar&#8221; tab_id=&#8221;1524479441950-dddd4fdf-5220&#8243;][vc_column_text]<\/p>\n<ul>\n<li><a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2019\/CEIm\/Calendario%20reuniones%20Ceim_2020.pdf\" target=\"_blank\" rel=\"noopener\">Calendar 2020 (Spanish)<\/a><\/li>\n<li><a href=\"https:\/\/imas12.es\/wp-content\/uploads\/2019\/CEIm\/Calendario%20reuniones%20Ceim_2019.pdf\" target=\"_blank\" rel=\"noopener\">Calendar 2019 (Spanish)<\/a><\/li>\n<\/ul>\n<ul>\n<li><a href=\"http:\/\/imas12.es\/wp-content\/uploads\/2018\/CEIm\/Marzo\/Calendario%20reuniones%20Ceim_2018.pdf\" target=\"_blank\" rel=\"noopener\">Calendar 2018 (Spanish)<\/a><\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_tta_section][vc_tta_section title=&#8221;Contact&#8221; tab_id=&#8221;1524479442619-037de40c-8cec&#8221;][vc_column_text]<\/p>\n<p><strong><span style=\"color: #000000\">Technical\u00a0staff and scientific support<\/span><\/strong><\/p>\n<p>Mar\u00eda Ugalde D\u00edez. Tlf. 91 779 26 13<br \/>\ne-mail:\u00a0<a class=\"western\" href=\"mailto:mugalde.imas12@h12o.es\" target=\"_blank\" rel=\"noopener\">mugalde.imas12@h12o.es<\/a><\/p>\n<p>Sarahi Valdez Acosta. Tlf. 91 779 26 14<br \/>\ne-mail:\u00a0<a class=\"western\" href=\"mailto:stecnicacei@h12o.es\" target=\"_blank\" rel=\"noopener\">stecnicacei@h12o.es<\/a><\/p>\n<p><strong>Documentation management\u2019s\u00a0Administrative staff<\/strong><\/p>\n<p><strong>Clinical trials<\/strong>: Sara P\u00e9rez de Lara. Tlf. 91 779 26 16<\/p>\n<p>e-mail:\u00a0<a class=\"western\" href=\"mailto:ceic@h12o.es\" target=\"_blank\" rel=\"noopener\">ceicdoc@h12o.es<\/a><\/p>\n<p><strong>Projects and EPAs<\/strong>: Sara P\u00e9rez de Lara. Tlf. 91 779 26 16<\/p>\n<p>e-mail:\u00a0<a class=\"western\" href=\"mailto:ceic@h12o.es\" target=\"_blank\" rel=\"noopener\">ceicdoc@h12o.es<\/a><\/p>\n<p>[\/vc_column_text][\/vc_tta_section][\/vc_tta_tabs][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row][vc_column][vc_tta_tabs style=&#8221;modern&#8221; color=&#8221;orange&#8221; active_section=&#8221;1&#8243;][vc_tta_section title=&#8221;Presentation&#8221; tab_id=&#8221;1524479253922-db3f7d63-9113&#8243;][vc_column_text] &nbsp; On 13 January 2016, the new Royal Decree 1090\/2015 came into effect, regulating clinical trials with drugs, the Research Ethics Committees with medicines and the Spanish Registry of Clinical Studies. This royal decree&#8230;<\/p>\n","protected":false},"author":8,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4643","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/imas12.es\/en\/wp-json\/wp\/v2\/pages\/4643","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/imas12.es\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/imas12.es\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/imas12.es\/en\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/imas12.es\/en\/wp-json\/wp\/v2\/comments?post=4643"}],"version-history":[{"count":20,"href":"https:\/\/imas12.es\/en\/wp-json\/wp\/v2\/pages\/4643\/revisions"}],"predecessor-version":[{"id":5429,"href":"https:\/\/imas12.es\/en\/wp-json\/wp\/v2\/pages\/4643\/revisions\/5429"}],"wp:attachment":[{"href":"https:\/\/imas12.es\/en\/wp-json\/wp\/v2\/media?parent=4643"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}