{"id":8548,"date":"2020-12-18T08:21:47","date_gmt":"2020-12-18T06:21:47","guid":{"rendered":"https:\/\/www.incliva.es\/ceim\/requisitos\/"},"modified":"2026-03-09T08:18:00","modified_gmt":"2026-03-09T06:18:00","slug":"evaluation-requirements","status":"publish","type":"page","link":"https:\/\/www.incliva.es\/en\/services\/researcher-services\/scientific-management\/ceim\/evaluation-requirements\/","title":{"rendered":"Evaluation requirements"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#e2e2e2;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-center fusion-flex-justify-content-center\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_4 1_4 fusion-flex-column fusion-flex-align-self-center\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-center fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div ><style type=\"text\/css\">.fusion-button.button-1 {border-radius:4px;}<\/style><a class=\"fusion-button button-flat button-large button-default button-1 fusion-button-span-yes fusion-button-default-type\" target=\"_self\" href=\"\/en\/services\/researcher-services\/scientific-management\/ceim\/composition\"><span class=\"fusion-button-text\">Composition<\/span><\/a><\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-0{width:25% !important;margin-top : 0px;margin-bottom : 20px;}.fusion-builder-column-0 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 7.68%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 7.68%;}@media only screen and (max-width:1532px) {.fusion-body .fusion-builder-column-0{width:25% !important;order : 0;}.fusion-builder-column-0 > .fusion-column-wrapper {margin-right : 7.68%;margin-left : 7.68%;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-0{width:100% !important;order : 0;}.fusion-builder-column-0 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}<\/style><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_4 1_4 fusion-flex-column fusion-flex-align-self-center\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-center fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div ><style type=\"text\/css\">.fusion-button.button-2 {border-radius:4px;}<\/style><a class=\"fusion-button button-flat button-large button-default button-2 fusion-button-span-yes fusion-button-default-type\" target=\"_self\" href=\"\/en\/services\/researcher-services\/scientific-management\/ceim\/evaluation-requirements\"><span class=\"fusion-button-text\">Evaluation requirements<\/span><\/a><\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-1{width:25% !important;margin-top : 0px;margin-bottom : 20px;}.fusion-builder-column-1 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 7.68%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 7.68%;}@media only screen and (max-width:1532px) {.fusion-body .fusion-builder-column-1{width:25% !important;order : 0;}.fusion-builder-column-1 > .fusion-column-wrapper {margin-right : 7.68%;margin-left : 7.68%;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-1{width:100% !important;order : 0;}.fusion-builder-column-1 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}<\/style><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_4 1_4 fusion-flex-column fusion-flex-align-self-center\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-center fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div ><style type=\"text\/css\">.fusion-button.button-3 {border-radius:4px;}<\/style><a class=\"fusion-button button-flat button-large button-default button-3 fusion-button-span-yes fusion-button-default-type\" target=\"_self\" href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2024\/07\/Calendario-CEIm-2024-MODIFICACIONES.pdf\"><span class=\"fusion-button-text\">Meetings calendar<\/span><\/a><\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-2{width:25% !important;margin-top : 0px;margin-bottom : 20px;}.fusion-builder-column-2 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 7.68%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 7.68%;}@media only screen and (max-width:1532px) {.fusion-body .fusion-builder-column-2{width:25% !important;order : 0;}.fusion-builder-column-2 > .fusion-column-wrapper {margin-right : 7.68%;margin-left : 7.68%;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-2{width:100% !important;order : 0;}.fusion-builder-column-2 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}<\/style><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-3 fusion_builder_column_1_4 1_4 fusion-flex-column fusion-flex-align-self-center\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-center fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div ><style type=\"text\/css\">.fusion-button.button-4 {border-radius:4px;}<\/style><a class=\"fusion-button button-flat button-large button-default button-4 fusion-button-span-yes fusion-button-default-type\" target=\"_self\" href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2023\/04\/Tasas-evaluacion-CEIm-HCUV-2023.pdf\"><span class=\"fusion-button-text\">Fees<\/span><\/a><\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-3{width:25% !important;margin-top : 0px;margin-bottom : 20px;}.fusion-builder-column-3 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 7.68%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 7.68%;}@media only screen and (max-width:1532px) {.fusion-body .fusion-builder-column-3{width:25% !important;order : 0;}.fusion-builder-column-3 > .fusion-column-wrapper {margin-right : 7.68%;margin-left : 7.68%;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-3{width:100% !important;order : 0;}.fusion-builder-column-3 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}<\/style><\/div><style type=\"text\/css\">.fusion-body .fusion-flex-container.fusion-builder-row-1{ padding-top : 0px;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}<\/style><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"background-color: rgba(255,255,255,0);background-position: center center;background-repeat: no-repeat;border-width: 0px 0px 0px 0px;border-color:#e2e2e2;border-style:solid;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start\" style=\"max-width:1248px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-4 fusion_builder_column_2_3 2_3 fusion-flex-column\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;padding: 0px 0px 0px 0px;\"><div class=\"fusion-text fusion-text-1\" style=\"transform:translate3d(0,0,0);\"><h5 style=\"text-align: justify;\">Evaluation requirements<\/h5>\n<p>The promoter\/researcher must end the original documentation scanned and signed with certificate or electronic ID to Clinical Trials Information System (CITS), in the case of clinical trials, or to the direction <a href=\"mailto:ceic_hcv@gva.es\">ceic_hcv@gva.es<\/a>, for the rests of researches, studies or projects. On the email it must be indicated the studies title, protocols code, promotor and\/or Principal Investigator of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia.<\/p>\n<p>According to Royal Decree 957\/2020, of November 3, the CEIm must be informed of the start and end date of the study (maximum fifteen days after its completion), and a copy of the final report must be provided (within six months after its completion).<\/p>\n<p>The documentation can be sent any day of the month to the Technical Secretariat email.<\/p>\n<\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:10px;width:100%;\"><\/div><style type=\"text\/css\">#accordion-8548-1 .fusion-panel:hover, #accordion-8548-1 .fusion-panel.hover{ background-color: #f9f9fb } #accordion-8548-1 .fusion-panel { border-color:#9da0d2; border-width:1px; background-color:#ffffff; }.fusion-accordian  #accordion-8548-1 .panel-title a .fa-fusion-box{ color: #ffffff;}.fusion-accordian  #accordion-8548-1 .panel-title a .fa-fusion-box:before{ font-size: 14px; width: 14px;}.fusion-accordian  #accordion-8548-1 .panel-title a{font-size:16px;}.fusion-accordian  #accordion-8548-1 .fa-fusion-box { background-color: #212934;border-color: #212934;}.fusion-accordian  #accordion-8548-1 .panel-title a:hover, #accordion-8548-1 .fusion-toggle-boxed-mode:hover .panel-title a { color: #3db0bf;}.fusion-accordian  #accordion-8548-1 .panel-title .active .fa-fusion-box,.fusion-accordian  #accordion-8548-1 .panel-title a:hover .fa-fusion-box { background-color: #3db0bf!important;border-color: #3db0bf!important;}<\/style><div class=\"accordian fusion-accordian\"><div class=\"panel-group\" id=\"accordion-8548-1\" role=\"tablist\"><div class=\"fusion-panel panel-default fusion-toggle-no-divider fusion-toggle-boxed-mode\" role=\"tabpanel\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a aria-expanded=\"false\" aria-selected=\"false\" aria-controls=\"a5382be2051b4a6d1\" role=\"tab\" data-toggle=\"collapse\" data-parent=\"#accordion-8548-1\" data-target=\"#a5382be2051b4a6d1\" href=\"#a5382be2051b4a6d1\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Clinical Trials with medicines<\/span><\/a><\/h4><\/div><div id=\"a5382be2051b4a6d1\" class=\"panel-collapse collapse \"><div class=\"panel-body toggle-content fusion-clearfix\"><strong>Definition<\/strong><\/p>\n<p>The clinical trials, according to the Royal Decree 1090\/2015, are the clinical studies that meet any of the following conditions:<\/p>\n<ul>\n<li>The trial subject is assigned in advance to a particular therapeutic strategy, which is not part of the usual clinical practice of the Member State involved.<\/li>\n<li>The decision to prescribe medicines on research is made in conjunction with the decision to enroll the subject in the clinical trial.<\/li>\n<li>Diagnostic or follow-up procedures are applied to test subjects that go beyond standard clinical practice.<\/li>\n<\/ul>\n<p><strong>Normative<\/strong><\/p>\n<p>The clinical trials, according to the Royal Decree 1090\/2015, are the clinical studies that meet any of the following conditions:<\/p>\n<ul>\n<li>The trial subject is assigned in advance to a particular therapeutic strategy, which is not part of the usual clinical practice of the Member State involved.<\/li>\n<li>The decision to prescribe medicines on research is made in conjunction with the decision to enroll the subject in the clinical trial.<\/li>\n<li>Diagnostic or follow-up procedures are applied to test subjects that go beyond standard clinical practice.<\/li>\n<\/ul>\n<p><strong>Evaluation requirements by the CEIm<\/strong><\/p>\n<p>The documents that must be presented for the initial evaluation of a clinical trial with mediciness are indicated in the next link: \u201c<a href=\"https:\/\/www.aemps.gob.es\/medicamentos-de-uso-humano\/investigacion_medicamentos\/ensayosclinicos\/anexos-instrucciones-aemps-realiza-ec\/\">AEMPS instructions to make clinical trials in Spain<\/a>\u201d. On the documents of the clinical trials there are two different parts, part I (documents to send to the AEMPS and the CEIm, and documents to send only to the AEMPS) and part II (documents to send only to CEIm).<\/p>\n<p>The promoter must present the following documents trough the portal Clinical Trials Information System (link <a href=\"https:\/\/euclinicaltrials.eu\/ctis-for-sponsors\/\">CTIS<\/a>).<\/p>\n<ul>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2024\/02\/1.-F-CE-GEva-7E-v3-Requisitos-Ensayos-Clinicos-con-Medicamentos.pdf\">Initial evaluation<\/a><\/li>\n<li>Substantial modification (amendment)<\/li>\n<\/ul>\n<ol>\n<li>Presentation letter of the substantial modification.<\/li>\n<li>Substantial modification solicitude form.<\/li>\n<li>Summary and change justifications.<\/li>\n<li>Comparative table with previous text \u2500 new text.<\/li>\n<li>New version of the documents to be modified with \u201ctrack changes\u201d<\/li>\n<li>New version of the documents to be modified in a fair copy.<\/li>\n<li>New documents.<\/li>\n<li>Documents supporting the changes, if applicable.<\/li>\n<li>Billing data for payment of the assessment fee or fee waiver request.<\/li>\n<\/ol>\n<p>Those clinical trials initiated under the previous regulations and submitted on the Clinical Trials Portal may submit substantial modifications under the same portal until 2025.<\/p>\n<p>The management of the contract will be processed in parallel to the application by the CEIm of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia; for this purpose, please contact the Contracts Management Area of the Foundation at the following address <a href=\"ensayosclinicos@incliva.es\">ensayosclinicos@incliva.es<\/a>.<\/p>\n<p><strong>Favorable opinion of another CEIm<\/strong><\/p>\n<p>According with the provisions of Article 17 of Royal Decree 1090\/2015, all clinical trials with medicinal products will require the favorable opinion of a CEIm accredited in Spain. Said opinion will be unique, binding and recognized throughout the national territory. Therefore, in these cases, the CEIm recognizes the approval and the study will not be re-evaluated. The documentation to be provided by the promoter to the CEIm of the HCUV (<a href=\"mailto:ceic_hcv@gva.es\">ceic_hcv@gva.es<\/a>) is:<\/p>\n<ul>\n<li>Suitability of the facilities according to the model published by the AEMPS.<\/li>\n<li>Abbreviated curriculum vitae (CV) of the principal investigator.<\/li>\n<li>Declaration of conflict of interest, if not included in the CV.<\/li>\n<li>Training in good clinical practice, if not included in the CV.<\/li>\n<\/ul>\n<p>The management of the contract will be processed in parallel to the application by the CEIm of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia; for this purpose, please contact the Contract Management Area of the Foundation at <a href=\"ensayosclinicos@incliva.es.\">ensayosclinicos@incliva.es.<\/a><\/p>\n<p><strong>Documents models<br \/>\n<\/strong><\/p>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/2.-F-CE-GEva-2C-v1-Modelo-Hoja-de-Informacion-al-Paciente-2.docx\">Patients\u2019 information sheet<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/3.-F-CE-GEva-12C-v2-Memoria-Economica-Estudios-Clinicos.docx\">Economic report<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/4.-F-CE-GEva-6C-v1.1-Procedimientos-y-Material-Reclutamiento.docx\">Proceedings and recruitment material<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-toggle-no-divider fusion-toggle-boxed-mode\" role=\"tabpanel\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a aria-expanded=\"false\" aria-selected=\"false\" aria-controls=\"3d668dcae1987e284\" role=\"tab\" data-toggle=\"collapse\" data-parent=\"#accordion-8548-1\" data-target=\"#3d668dcae1987e284\" href=\"#3d668dcae1987e284\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Clinical research with medical devices <\/span><\/a><\/h4><\/div><div id=\"3d668dcae1987e284\" class=\"panel-collapse collapse \"><div class=\"panel-body toggle-content fusion-clearfix\"><strong>Definition<\/strong><\/p>\n<p>A medical device is any instrument, device, equipment, software, implant, reagent, material or other article intended by the manufacturer to be used on persons, separately or in combination, for specific medical purposes.<\/p>\n<p><strong>Normative<\/strong><\/p>\n<p>The <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32017R0745\">Regulation (EU) 2017\/745<\/a> of the European Parliament and of the Council of 5 April 2017 on medical devices establishes the general requirements in relation to the clinical research with medical devices on chapter VI and the Annexes XIV and XV thereof. The <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:02022R2346-20230622\">Regulation (EU) 2022\/2346<\/a> of the commission of December 1, 2022 establishes the common specification for the groups of devices without intended medical purpose listed in Annex XVI of Regulation (EU) 2017\/745 of the European Parliament and of the Council on medical devices.<\/p>\n<p>Favorable opinion emitted by CEIm of the national territory would be only and linked.<\/p>\n<p><strong>Types of medical devices<br \/>\n<\/strong><\/p>\n<p>On clinical researches with medical devices there are different situations listed on the AEMPS website:<\/p>\n<ol>\n<li>Medical devices without CE marking (article 62 of the Regulation).<\/li>\n<li>Medical devices with CE marking, but not used under authorized and usual conditions of use.<\/li>\n<\/ol>\n<p>Medical devices with CE marking following their instructions for use and within the intended purpose (Research Project).<\/p>\n<p><strong>Evaluation requirements by the CEIm<\/strong><\/p>\n<p><strong>1. Clinical research with medical devices without a CE market or with a CE market, but outside the scope of their intended purpose: <\/strong>the following documents must be submitted for initial evaluation or substantial modifications:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2024\/02\/1.-F-CE-GEva-6E-v2-Requisitos-Investigaciones-clinicas-con-Productos-sanitarios.pdf\"><strong>Initial evaluation<\/strong><\/a><\/li>\n<li>Substantial modification (amendment): the promoter must present the following documents:<\/li>\n<\/ul>\n<ol>\n<li>Presentation letter of the substantial modification.<\/li>\n<li>Summary and justification of the changes.<\/li>\n<li>Comparative table with previous text versus new text.<\/li>\n<li>New version of the documents to be modified with \u201ctrack changes\u201d<\/li>\n<li>New version of the documents to be modified in a fair copy.<\/li>\n<li>New documents, if applicable.<\/li>\n<li>Documents supporting the changes.<\/li>\n<li>Consequences of the modification.<\/li>\n<li>Billing details for payment of evaluation fee or fee exemption request.<\/li>\n<\/ol>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>2. Clinical research with medical devices with a CE market following the instructions use and inside the scope of their intended purpose: <\/strong>for the initial evaluation or substantial modifications, the following documents must be presented:<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2024\/02\/1.-F-CE-GEva-6E-v2-Requisitos-Investigaciones-clinicas-con-Productos-sanitarios.pdf\"><strong>Initial evaluation<\/strong><\/a><\/li>\n<li>Substantial modification (amendment): the promoter must present the following documents:<\/li>\n<\/ul>\n<ol>\n<li>Presentation letter of the substantial modification.<\/li>\n<li>Summary and justification of the changes.<\/li>\n<li>Comparative table with previous text versus new text.<\/li>\n<li>New version of the documents to be modified with \u201ctrack changes\u201d<\/li>\n<li>New version of the documents to be modified in a fair copy.<\/li>\n<li>New documents, if applicable.<\/li>\n<li>Documents supporting the changes.<\/li>\n<li>Consequences of the modification.<\/li>\n<li>Billing details for payment of evaluation fee or fee exemption request.<\/li>\n<\/ol>\n<p>The management of the contract will be processed in parallel to the application by the CEIm of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia; and for this purpose, they should contact the Contracts Management Area of the Foundation at the address <a href=\"mailto:ensayosclinicos@incliva.es\">ensayosclinicos@incliva.es<\/a>.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>Documents models<br \/>\n<\/strong><\/p>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/2.-F-CE-GEva-2C-v1-Modelo-Hoja-de-Informacion-al-Paciente-2.docx\">Patients\u2019 information sheet<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/3.-F-CE-GEva-12C-v2-Memoria-Economica-Estudios-Clinicos.docx\">Economic report<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/4.-F-CE-GEva-6C-v1.1-Procedimientos-y-Material-Reclutamiento.docx\">Proceedings and recruitment material<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-toggle-no-divider fusion-toggle-boxed-mode\" role=\"tabpanel\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a aria-expanded=\"false\" aria-selected=\"false\" aria-controls=\"3c14e7c10b9ee7c81\" role=\"tab\" data-toggle=\"collapse\" data-parent=\"#accordion-8548-1\" data-target=\"#3c14e7c10b9ee7c81\" href=\"#3c14e7c10b9ee7c81\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Observational studies with medicines<\/span><\/a><\/h4><\/div><div id=\"3c14e7c10b9ee7c81\" class=\"panel-collapse collapse \"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><strong>Definition<\/strong><\/p>\n<p>An observational study with medicines is any research involving the collection of individual data relating to the health of persons, provided that it does not meet any of the conditions required to be considered a clinical trial (established in Article 2.1.i) <a href=\"https:\/\/www.boe.es\/eli\/es\/rd\/2015\/12\/04\/1090\">of Royal Decree 1090\/2015<\/a> and that it is conducted for any of the following purposes:<\/p>\n<ul>\n<li>Determine the beneficial effects of medicines, as well as their modifying factors, including the patients&#8217; perspective, and their relationship to the resources used to achieve them.<\/li>\n<li>Identify, characterize or quantify adverse medicines reactions and other patient safety risks associated with the use of medicines, including potential risk factors or effect modifiers, and measure the effectiveness of risk management measures.<\/li>\n<li>Obtain information on medicines utilization patterns in the population.<\/li>\n<li>Observational studies with medicines are intended to complement known medicines information without interfering with routine clinical practice.<\/li>\n<\/ul>\n<p>The observational studies with medicines are intended to complement the known information on the medicines without interfering with routine clinical practice.<\/p>\n<p><strong>Normative<\/strong><\/p>\n<p>The Royal Decree 957\/2020, November 3, which regulates observational studies with medicinal products for human use, establishes the conditions for the evaluation, conduct and follow-up of observational studies with medicinal products for human use carried out in Spain.<\/p>\n<p>Favorable opinion emitted by CEIm of the national territory would be only and linked.<\/p>\n<p><strong>Evaluation requirements by the CEIm<\/strong><\/p>\n<p>The instructions of the Spanish Agency of Medicines and Health Products (AEMPS) for conducting observational studies with medicines can be found at the following link: <a href=\"https:\/\/www.aemps.gob.es\/investigacionClinica\/medicamentos\/docs\/estudios-PA\/Instrucciones-GESTO-REEC.pdf\">AEMPS<\/a>. In the case of prospective follow-up observational studies, authorization must be requested from the Autonomous Committee for Prospective Observational Studies of Medicines of the Valencian Community (<a href=\"https:\/\/www.gva.es\/es\/inicio\/procedimientos?id_proc=17838\">CAEPO<\/a>).<\/p>\n<p>For the initial evaluation or substantial modifications, the following documents must be presented:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2024\/02\/1.-F-CE-GEva-5B-v2-Requisitos-Estudios-Observacionales-con-Medicamentos.pdf\">Initial evaluation<\/a><\/li>\n<li>Substantial modification (amendment): the promoter must present the following documents:<\/li>\n<\/ul>\n<ol>\n<li>Presentation letter of the substantial modification.<\/li>\n<li>Summary and justification of the changes.<\/li>\n<li>Comparative table with previous text versus new text.<\/li>\n<li>New version of the documents to be modified with \u201ctrack changes\u201d<\/li>\n<li>New version of the documents to be modified in a fair copy.<\/li>\n<li>New documents, if applicable.<\/li>\n<li>Documents supporting the changes.<\/li>\n<li>Consequences of the modification.<\/li>\n<li>Billing details for payment of evaluation fee or fee exemption request.<\/li>\n<\/ol>\n<p>The management of the contract will be processed in parallel to the application by the CEIm of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia; and for this purpose, they should contact the Contracts Management Area of the Foundation at the address <a href=\"ensayosclinicos@incliva.es.\">ensayosclinicos@incliva.es.<\/a><\/p>\n<p><strong>\u00a0Documents models<\/strong><\/p>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/2.-F-CE-GEva-2C-v1-Modelo-Hoja-de-Informacion-al-Paciente-2.docx\">Patients\u2019 information sheet<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/3.-F-CE-GEva-12C-v2-Memoria-Economica-Estudios-Clinicos.docx\">Economic report<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-toggle-no-divider fusion-toggle-boxed-mode\" role=\"tabpanel\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a aria-expanded=\"false\" aria-selected=\"false\" aria-controls=\"c98589066088cdb46\" role=\"tab\" data-toggle=\"collapse\" data-parent=\"#accordion-8548-1\" data-target=\"#c98589066088cdb46\" href=\"#c98589066088cdb46\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Research projects<\/span><\/a><\/h4><\/div><div id=\"c98589066088cdb46\" class=\"panel-collapse collapse \"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p><strong>Definition<\/strong><\/p>\n<p>A research project is any biomedical research involving interventions on human beings, the performance of genetic analyses, the processing of genetic data of a personal nature or of biological samples of human origin.<\/p>\n<p><strong>Normative<\/strong><\/p>\n<p>According to <a href=\"https:\/\/www.boe.es\/eli\/es\/l\/2007\/07\/03\/14\">Law 14\/2007<\/a>, of July 3, 2007, on Biomedical Research, the authorization and development of any research project on human beings or their biological material will require the prior and mandatory favorable report of the Research Ethics Committee. The law is built on the principles of the integrity of persons and the protection of the dignity and identity of the human being in any biomedical research. The same obligation is provided for in the <a href=\"https:\/\/www.boe.es\/eli\/es\/lo\/2018\/12\/05\/3\/con\">Organic Law 3\/2018<\/a>, of December 5, on the Protection of Personal Data and guarantee of digital rights) and in the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32022R0868\">Implementing Regulation (EU) 2022\/868<\/a> of the European Parliament and of the Council of 30 May 2022 on European data governance.<\/p>\n<p>Order SSI\/81\/2017 of January 19 establishes the basic guidelines for action aimed at guaranteeing the patient&#8217;s right to dignity and privacy when attended by professionals undergoing specialized training in Health Sciences (residents in training). The following document contains some points of particular relevance of this Order SSI\/81\/2017: <a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2024\/02\/0.-PD-v1.1-Protocolo-de-confidencialidad_estudios-academicos.pdf\">protocol of confidentiality of academic studies.<\/a><\/p>\n<p><strong>Evaluation requirements by the CEIm<\/strong><\/p>\n<p>For the initial evaluation or substantial modifications, the following documents must be presented:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2025\/06\/F-CE-GEva-6P-v2.1-Requisitos-proyectos.pdf\">Initial evaluation<\/a><\/li>\n<li>Substantial modification (amendment): the following documentation must be submitted at the email <a href=\"ceic_hcv@gva.es\">ceic_hcv@gva.es<\/a><\/li>\n<\/ul>\n<ol>\n<li>A presentation letter that includes the summary and the changes justification.<\/li>\n<li>New version of the documents to be modified with \u201ctrack changes\u201d.<\/li>\n<li>New version of the documents to be modified in a fair copy.<\/li>\n<li>New documents, if necessary.<\/li>\n<\/ol>\n<p><strong>Documents models<\/strong>:<\/p>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/2.-F-CE-GEva-7P-v1-Expediente.docx\">Submission of documentation (&#8220;Dossier&#8221;)<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/02\/3.-Compromiso_residentes.pdf\">Confidentiality agreement for residents<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/02\/3.-Compromiso_alumnos.pdf\">Confidentiality agreement for students<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/4.-F-CE-GEva-8P-v1-Plantilla-Proyecto-propio-INCLIVA.docx\">Project template<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/2.-F-CE-GEva-2C-v1-Modelo-Hoja-de-Informacion-al-Paciente-2.docx\">Patient information sheet<\/a><\/li>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2026\/02\/F-CE-GEva-24C-v1-Hoja-de-informacion-a-representante-legal-del-menor.docx\" target=\"_blank\" rel=\"noopener\">Hoja de informaci\u00f3n a representante legal del menor<\/a><\/li>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2026\/02\/F-CE-GEva-25C-v1-Asentimiento-del-menor.docx\" target=\"_blank\" rel=\"noopener\"><span data-olk-copy-source=\"MessageBody\">Asentimiento del menor<\/span><\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/6.-F-CE-GEva-9P-v1-Modelo-Solicitud-Exencion-Consentimiento.docx\">Informed consent extension request template<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/F-CE-GEva-8C-v2-Compromiso-IP-y-Autorizacion-JS.docx\">Principal Investigator&#8217;s commitment and Service Chief&#8217;s authorization<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/8.-F-CE-GEva-9C-v1.1-Informe-Investigador-Principal.docx\">Principal Investigator&#8217;s report<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/9.-F-CE-GEva-10C-v1.1-Conformidad-Servicios-Implicados.docx\">Approval from involved departments<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/10.-F-CE-GEva-11C-v1.1-Memoria-Economica-Proyecto.docx\">Project economic report<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/F-CE-GEva-23C-v1-Compromiso-confidencialidad-colaboradores.docx\">Confidentiality agreement for external researchers of the Regional Ministry for Health of the Valencian Government.<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-toggle-no-divider fusion-toggle-boxed-mode\" role=\"tabpanel\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a aria-expanded=\"false\" aria-selected=\"false\" aria-controls=\"0934bac2f2a7f32e4\" role=\"tab\" data-toggle=\"collapse\" data-parent=\"#accordion-8548-1\" data-target=\"#0934bac2f2a7f32e4\" href=\"#0934bac2f2a7f32e4\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Research projects for academic purposes (Thesis, TFG, TFM)<\/span><\/a><\/h4><\/div><div id=\"0934bac2f2a7f32e4\" class=\"panel-collapse collapse \"><div class=\"panel-body toggle-content fusion-clearfix\">\n<p>According with the <a href=\"https:\/\/www.uv.es\/uvweb\/medicine\/en\/undergraduate-degree-studies\/degree-final-project\/medicine-tfg-1285996851035.html\">regulations of the University of Valencia<\/a>, the end-of-degree project (TFG)\u00a0 in the modality of research work involving patients must have a favorable report from the CEIC or CEIm of the Center where the research is carried out.<\/p>\n<p>If the research topic of the Master&#8217;s Thesis (TFM) or Doctoral Thesis is related to animal experimentation, biosafety or human research, even if it is only the use of medical records, biological samples of human origin or biological agents, the evaluation by the CEIC or CEIm of the Center where the research is carried out must be requested prior to its realization (<a href=\"www.uv.es\/uvetica\">www.uv.es\/uvetica<\/a>).<\/p>\n<p><strong>Normative<\/strong><\/p>\n<p><a href=\"https:\/\/www.boe.es\/diario_boe\/txt.php?id=BOE-A-2017-1200\">Order SSI\/81\/2017<\/a> of January 19 establishes the basic guidelines for action aimed at guaranteeing the patient&#8217;s right to dignity and privacy when attended in the presence of students of degrees related to health sciences (students) and when attended by professionals undergoing specialized training in Health Sciences (residents in training). The following document contains some points of particular relevance of this Order SSI\/81\/2017: <a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2024\/02\/0.-PD-v1.1-Protocolo-de-confidencialidad_estudios-academicos.pdf\">protocol of confidentiality of academic studies.<\/a><\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>Evaluation requirements by the CEIm<\/strong><\/p>\n<p>For the initial evaluation or substantial modifications, the following documents must be presented:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2025\/06\/F-CE-GEva-10P-v1.1-Requisitos-proyectos-academicos.pdf\">Initial evaluation<\/a><\/li>\n<li>Substantial modification (amendment): the following documentation must be submitted at the email <a href=\"ceic_hcv@gva.es\">ceic_hcv@gva.es<\/a><\/li>\n<\/ul>\n<ol>\n<li>A presentation letter that includes the summary and the changes justification.<\/li>\n<li>New version of the documents to be modified with \u201ctrack changes\u201d.<\/li>\n<li>New version of the documents to be modified in a fair copy.<\/li>\n<li>New documents, if necessary.<\/li>\n<\/ol>\n<p><strong>Documents models<br \/>\n<\/strong><\/p>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/2.-F-CE-GEva-7P-v1-Expediente.docx\">Submission of documentation (&#8220;Dossier&#8221;)<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/02\/3.-Compromiso_residentes.pdf\">Confidentiality agreement for residents<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/02\/3.-Compromiso_alumnos.pdf\">Confidentiality agreement for students<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/4.-F-CE-GEva-8P-v1-Plantilla-Proyecto-propio-INCLIVA.docx\">Project template<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/2.-F-CE-GEva-2C-v1-Modelo-Hoja-de-Informacion-al-Paciente-2.docx\">Patient information sheet<\/a><\/li>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2026\/02\/F-CE-GEva-24C-v1-Hoja-de-informacion-a-representante-legal-del-menor.docx\" target=\"_blank\" rel=\"noopener\">Hoja de informaci\u00f3n a representante legal del menor<\/a><\/li>\n<li><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2026\/02\/F-CE-GEva-25C-v1-Asentimiento-del-menor.docx\" target=\"_blank\" rel=\"noopener\"><span data-olk-copy-source=\"MessageBody\">Asentimiento del menor<\/span><\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/6.-F-CE-GEva-9P-v1-Modelo-Solicitud-Exencion-Consentimiento.docx\">Informed consent extension request template<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/F-CE-GEva-8C-v2-Compromiso-IP-y-Autorizacion-JS.docx\">Principal Investigator&#8217;s commitment and Service Chief&#8217;s authorization<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/8.-F-CE-GEva-9C-v1.1-Informe-Investigador-Principal.docx\">Principal Investigator&#8217;s report<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/9.-F-CE-GEva-10C-v1.1-Conformidad-Servicios-Implicados.docx\">Approval from involved departments<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/10.-F-CE-GEva-11C-v1.1-Memoria-Economica-Proyecto.docx\">Project economic report<\/a><\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/F-CE-GEva-23C-v1-Compromiso-confidencialidad-colaboradores.docx\">Confidentiality agreement for external researchers of the Regional Ministry for Health of the Valencian Government<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-toggle-no-divider fusion-toggle-boxed-mode\" role=\"tabpanel\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a aria-expanded=\"false\" aria-selected=\"false\" aria-controls=\"9dc60fd1a60910c72\" role=\"tab\" data-toggle=\"collapse\" data-parent=\"#accordion-8548-1\" data-target=\"#9dc60fd1a60910c72\" href=\"#9dc60fd1a60910c72\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Research projects that involve Induced Pluripotent Stem Cells (iPSC)<\/span><\/a><\/h4><\/div><div id=\"9dc60fd1a60910c72\" class=\"panel-collapse collapse \"><div class=\"panel-body toggle-content fusion-clearfix\"><strong>Normative<\/strong><\/p>\n<p>According to the latest amendment of September 05, 2022 of Law 14\/2007, of July 3, on Biomedical Research, the Research Ethics Committees are responsible for the authorization of research projects with human pluripotent cells obtained by cellular reprogramming when they involve:<\/p>\n<ol>\n<li>a) Its generation through the use of non-embryonic somatic cells from healthy or diseased donors and their characterization, including the formation of teratomas.<\/li>\n<li>b) Its generation from registered cells, of human origin, non-embryonic, coming from biobanks or of commercial origin.<\/li>\n<li>c) Its use or that of its derivatives, coming from biobanks or from researchers in other countries for in vitro research, except those that have reproductive purposes, gamete production and formation of interspecies primary chimeras.<\/li>\n<\/ol>\n<p><strong>Evaluation requirements by the CEIm<\/strong><\/p>\n<p>For the initial evaluation or substantial modifications of research projects involving Induced Pluripotent Stem Cells (iPSC) the following documents must be presented:<\/p>\n<ul>\n<li>Initial evaluation<\/li>\n<li>Substantial modification (amendment): the following documentation must be submitted at the email (<a href=\"mailto:ceic_hcv@gva.es\">ceic_hcv@gva.es<\/a>)<\/li>\n<\/ul>\n<ol>\n<li>A presentation letter that includes the summary and the changes justification.<\/li>\n<li>New version of the documents to be modified with \u201ctrack changes\u201d.<\/li>\n<li>New version of the documents to be modified in a fair copy.<\/li>\n<li>New documents, if necessary.<\/li>\n<\/ol>\n<p><strong>Documents models<br \/>\n<\/strong><\/p>\n<p>The Institute of Health Carlos III has drafted a document with the indications for the drafting of the <a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2024\/02\/2.Requisitos-Carlos-III_HIP_IPSC.pdf\">Participant Information Sheet<\/a> and the Informed Consent for research projects involving the generation of iPSCs.<\/p>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/3.F-CE-GEva-12P-v1-Hoja-de-informacion-al-paciente-iPSC.docx\">Patient information sheet<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><div class=\"fusion-panel panel-default fusion-toggle-no-divider fusion-toggle-boxed-mode\" role=\"tabpanel\"><div class=\"panel-heading\"><h4 class=\"panel-title toggle\"><a aria-expanded=\"false\" aria-selected=\"false\" aria-controls=\"6330f9e2efd33be38\" role=\"tab\" data-toggle=\"collapse\" data-parent=\"#accordion-8548-1\" data-target=\"#6330f9e2efd33be38\" href=\"#6330f9e2efd33be38\"><span class=\"fusion-toggle-icon-wrapper\" aria-hidden=\"true\"><i class=\"fa-fusion-box\" aria-hidden=\"true\"><\/i><\/span><span class=\"fusion-toggle-heading\">Registro de datos con fines de investigaci\u00f3n<\/span><\/a><\/h4><\/div><div id=\"6330f9e2efd33be38\" class=\"panel-collapse collapse \"><div class=\"panel-body toggle-content fusion-clearfix\"><strong>Definici\u00f3n<\/strong><\/p>\n<p>Los registros m\u00e9dicos o de enfermedades son sistemas estructurados de recopilaci\u00f3n, almacenamiento y gesti\u00f3n de datos cl\u00ednicos y epidemiol\u00f3gicos sobre pacientes afectados por una enfermedad espec\u00edfica, un grupo de enfermedades o una condici\u00f3n de salud. Su prop\u00f3sito principal es servir como herramienta para la vigilancia epidemiol\u00f3gica, la investigaci\u00f3n cl\u00ednica, la evaluaci\u00f3n de tratamientos y la planificaci\u00f3n de pol\u00edticas de salud p\u00fablica. Estos registros contienen informaci\u00f3n estandarizada, como datos demogr\u00e1ficos, diagn\u00f3sticos, tratamientos, resultados de salud y seguimiento longitudinal de los pacientes.<\/p>\n<p>Para garantizar su calidad, interoperabilidad y comparabilidad internacional, suelen utilizar est\u00e1ndares reconocidos como la Clasificaci\u00f3n Internacional de Enfermedades (CIE-10), SNOMED CT y FHIR.<\/p>\n<p>Asimismo, est\u00e1n sujetos a estrictas normativas \u00e9ticas y legales, como el Reglamento General de Protecci\u00f3n de Datos (RGPD) en Europa o la HIPAA en EE. UU., que aseguran la protecci\u00f3n y confidencialidad de los datos personales. Los registros pueden ser gestionados por instituciones p\u00fablicas, privadas o mixtas y requieren procedimientos rigurosos de autorizaci\u00f3n para el acceso a sus datos, a fin de garantizar un uso leg\u00edtimo y responsable en investigaci\u00f3n biom\u00e9dica, cl\u00ednica y de salud poblacional.<\/p>\n<p><strong>Normativa<\/strong><\/p>\n<p>En Espa\u00f1a, la operaci\u00f3n de los registros m\u00e9dicos o de enfermedades est\u00e1 sujeta a un marco normativo que combina legislaci\u00f3n nacional y europea para garantizar la protecci\u00f3n de datos personales y el uso \u00e9tico de la informaci\u00f3n cl\u00ednica. A nivel europeo, el <strong>Reglamento General de Protecci\u00f3n de Datos (RGPD, UE 2016\/679)<\/strong> establece los principios fundamentales para el tratamiento de datos personales, desarrollando detalladamente los aplicables a los de <strong>categor\u00edas especiales<\/strong>, como los datos de salud, exigiendo para su uso, el consentimiento expl\u00edcito del paciente o su tratamiento por inter\u00e9s p\u00fablico, investigaci\u00f3n cient\u00edfica o fines estad\u00edsticos. En el \u00e1mbito nacional, la <strong>Ley Org\u00e1nica 3\/2018, de Protecci\u00f3n de Datos Personales y garant\u00eda de los derechos digitales (LOPDGDD)<\/strong> adapta el RGPD al contexto espa\u00f1ol, especificando las condiciones para el tratamiento de datos de salud y su seudonimizaci\u00f3n. Adem\u00e1s, la <strong>Ley 14\/2007, de Investigaci\u00f3n Biom\u00e9dica<\/strong> regula el uso de datos en la investigaci\u00f3n cient\u00edfica y establece los requisitos para los registros relacionados con ensayos cl\u00ednicos y estudios observacionales. En el caso de registros de enfermedades espec\u00edficas, como el c\u00e1ncer, la <strong>Ley 33\/2011, General de Salud P\u00fablica<\/strong>, y los decretos auton\u00f3micos tambi\u00e9n pueden imponer la obligatoriedad de notificaci\u00f3n y registro. Estas normas garantizan la <strong>seguridad, confidencialidad<\/strong> e <strong>interoperabilidad<\/strong> de los registros, permitiendo su uso responsable en investigaci\u00f3n y salud p\u00fablica.<\/p>\n<p><strong>Requisitos para la evaluaci\u00f3n por el CEIm<\/strong><\/p>\n<ol>\n<li><a href=\"\/wp-content\/uploads\/2025\/02\/F-CE-GEva-2R-v1.1-Declaracion-responsable-de-uso-confidencial.docx\" target=\"_blank\" rel=\"noopener\"><strong><u>F<\/u><\/strong><strong><u>\u2010CE<\/u><\/strong><strong><u>\u2010GEva<\/u><\/strong><strong><u>\u20102R<\/u><\/strong><\/a> Declaraci\u00f3n responsable de uso confidencial, cumplimentado y firmado por el personal solicitante y el titular<\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/12\/F-CE-GEva-3R-v1-Consentimiento-informado_tratamiento-y-cesion-de-datos-a-registros.docx\" target=\"_blank\" rel=\"noopener\"><strong><u>F<\/u><\/strong><strong><u>\u2010CE<\/u><\/strong><strong><u>\u2010GEva<\/u><\/strong><strong><u>\u20103R<\/u><\/strong><\/a> Consentimiento informado de tratamiento y cesi\u00f3n de datos a registros, cumplimentado con los datos del registro<\/li>\n<li>Documentaci\u00f3n de <strong><u>informaci\u00f3n general sobre el registro<\/u><\/strong>, generalmente es elaborada por el titular, sobre:\n<ul>\n<li>las finalidades y el objetivo general del registro<\/li>\n<li>la descripci\u00f3n o listado de las variables que se pretende recoger y la tipolog\u00eda de personas de las que provienen<\/li>\n<\/ul>\n<\/li>\n<li><strong><u>Informaci\u00f3n sobre el procedimiento o mecanismo para que los investigadores realicen la solicitud de acceso<\/u><\/strong>\/uso de los datos del registro. La solicitud suele\/deber\u00eda incluir:\n<ul>\n<li>El protocolo de investigaci\u00f3n aprobado por un Comit\u00e9 de \u00c9tica para Investigaci\u00f3n.<\/li>\n<li>Informaci\u00f3n sobre los responsables del proyecto (instituci\u00f3n, equipo de investigaci\u00f3n).<\/li>\n<li>Justificaci\u00f3n del uso de los datos solicitados (criterio de necesidad y proporcionalidad).<\/li>\n<li>Declaraci\u00f3n de cumplimiento \u00e9tico y legal.<\/li>\n<li>Plan de gesti\u00f3n y protecci\u00f3n de la confidencialidad de los datos.<\/li>\n<\/ul>\n<\/li>\n<li><strong><u>Informaci\u00f3n sobre el procedimiento o mecanismo para la evaluaci\u00f3n de las solicitudes<\/u><\/strong> de acceso a datos presentadas. De manera general, en un registro la evaluaci\u00f3n se realiza y aprueba por distintos \u00f3rganos colegiados, por ejemplo, los siguientes:\n<ul>\n<li><strong>Comit\u00e9s de \u00c9tica en Investigaci\u00f3n (CEI)<\/strong>: Para garantizar que el uso de los datos cumple principios \u00e9ticos (Declaraci\u00f3n de Helsinki).<\/li>\n<li><strong>Comit\u00e9s Cient\u00edficos o T\u00e9cnicos<\/strong>: Para evaluar la calidad y relevancia del proyecto.<\/li>\n<li><strong>Organismo Gestor del Registro<\/strong>: Para verificar que el uso de los datos cumple con sus pol\u00edticas y t\u00e9rminos de acceso.<\/li>\n<li>Puntos Clave Evaluados:<\/li>\n<li>Justificaci\u00f3n y relevancia del estudio.<\/li>\n<li>Minimizaci\u00f3n de riesgos para la confidencialidad de los pacientes.<\/li>\n<li>Cumplimiento de la normativa de protecci\u00f3n de datos (anonimizaci\u00f3n o pseudonimizaci\u00f3n).<\/li>\n<li>Capacidad t\u00e9cnica y cient\u00edfica del investigador y su equipo.<\/li>\n<\/ul>\n<\/li>\n<li>El \u201c<strong><u>modelo de acuerdo de uso de datos<\/u><\/strong>\u201d que el registro firma con cada investigador que es autorizado para usar los datos. Este acuerdo suele\/deber\u00eda incluir los siguientes aspectos:\n<ul>\n<li>Condiciones espec\u00edficas de acceso y uso de los datos.<\/li>\n<li>Limitaciones sobre la <strong>reutilizaci\u00f3n o distribuci\u00f3n<\/strong> de los datos.<\/li>\n<li>Compromiso de anonimizaci\u00f3n de resultados y protecci\u00f3n de la confidencialidad.<\/li>\n<li>Periodo de tiempo autorizado para el uso de los datos.<\/li>\n<li>Obligaci\u00f3n de devoluci\u00f3n o destrucci\u00f3n de los datos tras finalizar el estudio.<\/li>\n<\/ul>\n<\/li>\n<li><strong><u>Descripci\u00f3n de las medidas de seguridad<\/u><\/strong> del registro. Dentro de ellas:\n<ul>\n<li>especificar el lugar donde se almacenar\u00e1n los datos<\/li>\n<li>Indicar las medidas de seguridad t\u00e9cnicas y organizativas existentes, as\u00ed como cualquier est\u00e1ndar de seguridad que el registro cumpla (ENS, ISO 270001, etc.)<\/li>\n<li>la descripci\u00f3n o identificaci\u00f3n de personas que tendr\u00e1n acceso a los datos como parte de la operaci\u00f3n y mantenimiento del registro<\/li>\n<li>informaci\u00f3n sobre evaluaciones de impacto a la privacidad o an\u00e1lisis de riesgos realizados<\/li>\n<\/ul>\n<\/li>\n<\/ol>\n<p><strong>Modelos de documentos<\/strong><\/p>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2025\/02\/F-CE-GEva-2R-v1.1-Declaracion-responsable-de-uso-confidencial.docx\" target=\"_blank\" rel=\"noopener\"><strong><u>F<\/u><\/strong><strong><u>\u2010CE<\/u><\/strong><strong><u>\u2010GEva<\/u><\/strong><strong><u>\u20102R<\/u><\/strong><\/a> Declaraci\u00f3n responsable de uso confidencial<\/li>\n<li><a href=\"\/wp-content\/uploads\/2024\/12\/F-CE-GEva-3R-v1-Consentimiento-informado_tratamiento-y-cesion-de-datos-a-registros.docx\" target=\"_blank\" rel=\"noopener\"><strong><u>F<\/u><\/strong><strong><u>\u2010CE<\/u><\/strong><strong><u>\u2010GEva<\/u><\/strong><strong><u>\u20103R<\/u><\/strong><\/a> Consentimiento informado de tratamiento y cesi\u00f3n de datos a registros<\/li>\n<\/ul>\n<\/div><\/div><\/div><\/div><\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:10px;margin-bottom:10px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"border-color:#9da0d2;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-2\" style=\"transform:translate3d(0,0,0);\"><h5 style=\"text-align: justify;\">Other documents<\/h5>\n<ul>\n<li><a href=\"\/wp-content\/uploads\/2024\/11\/F-CE-GEva-5P-v1-Consentimiento-informado-para-uso-de-imagen-en-comunicacion-cientifica.docx\">Informed consent for the use of images in scientific communications.<\/a><\/li>\n<\/ul>\n<\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-4{width:66.666666666667% !important;margin-top : 0px;margin-bottom : 20px;}.fusion-builder-column-4 > .fusion-column-wrapper {padding-top : 0px !important;padding-right : 0px !important;margin-right : 2.88%;padding-bottom : 0px !important;padding-left : 0px !important;margin-left : 2.88%;}@media only screen and (max-width:1532px) {.fusion-body .fusion-builder-column-4{width:66.666666666667% !important;}.fusion-builder-column-4 > .fusion-column-wrapper {margin-right : 2.88%;margin-left : 2.88%;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-4{width:100% !important;}.fusion-builder-column-4 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}<\/style><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-5 fusion_builder_column_1_3 1_3 fusion-flex-column\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\" style=\"background-position:left top;background-repeat:no-repeat;-webkit-background-size:cover;-moz-background-size:cover;-o-background-size:cover;background-size:cover;background-color:#f9f9f9;border-width: 0 0 0 2px;border-color:#9da0d2;border-style:solid;padding: 4% 4% 4% 4%;\"><div class=\"fusion-text fusion-text-3\" style=\"transform:translate3d(0,0,0);\"><h5 class=\"titulo-coordinador\" style=\"text-align: center;\">President<\/h5>\n<p class=\"titulo-coordinador\" style=\"text-align: center;\">Dr. Marisa Luisa Calabuig<\/p>\n<h5 class=\"titulo-coordinador\" style=\"text-align: center;\">Vice president<\/h5>\n<p class=\"titulo-coordinador\" style=\"text-align: center;\">Dr. Esteban Morcillo<\/p>\n<h5 class=\"titulo-coordinador\" style=\"text-align: center;\">Head of the Technical Secretariat of the Committee<\/h5>\n<p class=\"nombre-coordinador\" style=\"text-align: center;\">Dr. Manuel Al\u00f3s<\/p>\n<\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:10px;margin-bottom:10px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"border-color:#9da0d2;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-4\" style=\"transform:translate3d(0,0,0);\"><h5 style=\"text-align: center;\">Personnel of the Technical Secretariat of the Committee<\/h5>\n<p style=\"text-align: center;\">Maialen Llopis<br \/>\nEster Penad\u00e9s Jord\u00e0<\/p>\n<\/div><div class=\"fusion-separator fusion-full-width-sep\" style=\"align-self: center;margin-left: auto;margin-right: auto;margin-top:10px;margin-bottom:10px;width:100%;\"><div class=\"fusion-separator-border sep-single sep-solid\" style=\"border-color:#9da0d2;border-top-width:1px;\"><\/div><\/div><div class=\"fusion-text fusion-text-5\" style=\"transform:translate3d(0,0,0);\"><h5 style=\"text-align: center;\">Contact<\/h5>\n<p style=\"text-align: center;\"><a href=\"mailto:ceic_hcv@gva.es\">ceic_hcv@gva.es<\/a><br \/>\nPhone:\u00a0<span data-olk-copy-source=\"MessageBody\">(+34) 96 254 23 96<\/span><\/p>\n<p style=\"text-align: center;\">Avenida Blasco Ib\u00e1\u00f1ez 17<br \/>\n46010 Valencia<\/p>\n<p style=\"text-align: center;\">Secretary:<br \/>\nAvenida Men\u00e9ndez Pelayo n\u00famero 3, local 14, 46010, Valencia<\/p>\n<\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-5{width:33.333333333333% !important;margin-top : 0px;margin-bottom : 20px;}.fusion-builder-column-5 > .fusion-column-wrapper {padding-top : 4% !important;padding-right : 4% !important;margin-right : 5.76%;padding-bottom : 4% !important;padding-left : 4% !important;margin-left : 5.76%;}@media only screen and (max-width:1532px) {.fusion-body .fusion-builder-column-5{width:33.333333333333% !important;order : 0;}.fusion-builder-column-5 > .fusion-column-wrapper {margin-right : 5.76%;margin-left : 5.76%;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-5{width:100% !important;order : 0;}.fusion-builder-column-5 > .fusion-column-wrapper {margin-right : 1.92%;margin-left : 1.92%;}}<\/style><\/div><style type=\"text\/css\">.fusion-fullwidth.fusion-builder-row-2 { overflow:visible; }.fusion-body .fusion-flex-container.fusion-builder-row-2{ padding-top : 2%;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}<\/style><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":8461,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"acf":[],"_links":{"self":[{"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/pages\/8548"}],"collection":[{"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/comments?post=8548"}],"version-history":[{"count":10,"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/pages\/8548\/revisions"}],"predecessor-version":[{"id":32416,"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/pages\/8548\/revisions\/32416"}],"up":[{"embeddable":true,"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/pages\/8461"}],"wp:attachment":[{"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/media?parent=8548"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}