{"id":47047,"date":"2025-12-04T13:44:23","date_gmt":"2025-12-04T11:44:23","guid":{"rendered":"https:\/\/www.incliva.es\/clinical-trials\/gestion-contrato-y-memoria-economica\/"},"modified":"2026-04-15T12:01:51","modified_gmt":"2026-04-15T10:01:51","slug":"contracts-and-financial-reports-management","status":"publish","type":"page","link":"https:\/\/www.incliva.es\/en\/clinical-trials\/contracts-and-financial-reports-management\/","title":{"rendered":"Contracts and Financial Reports Management"},"content":{"rendered":"<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-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-0 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;\">Management of clinical trial contract<\/h5>\n<p>Once the\u00a0<a href=\"\/en\/clinical-trials\/management-facilities\/\">management of the Facility Suitability Document<\/a>\u00a0has been completed by the Clinical Trials Unit of INCLIVA, the sponsor or CRO (Clinical Research Organization) must send the Clinical Trial Contract Template (<a href=\"\/wp-content\/uploads\/2025\/05\/F-EG-GEns-1-v2.3-Contrato-EC.docx\">Spanish<\/a>\u00a0and\u00a0<a href=\"\/wp-content\/uploads\/2025\/05\/F-EG-GEns-13-v2.3-Contrato-EC-Traducido.docx\">bilingual Spanish\/English<\/a>) and the <a href=\"\/wp-content\/uploads\/2024\/11\/Plantilla-ME-promotor_ESP_ENG-1.xlsx\">INCLIVA\u2019s sponsor Financial Report Template<\/a> duly completed.<\/p>\n<p>Both documents, duly completed, must be sent to the email address\u00a0<a href=\"mailto:contratoseecc@incliva.es\">contratoseecc@incliva.es<\/a>.<\/p>\n<p>For the final signature of the contract, the following documentation must be submitted by the sponsor\/CRO:<\/p>\n<ul>\n<li>Approval of the CEIm (Ethics Committees for Investigation with medicinal products). *<\/li>\n<li>Approval of the AEMPS (Agencia Espa\u00f1ola del Medicamento y Productos Sanitarios \u2013 Spanish Agency of Medicines and Medical Devices) or CTIS (Clinical Trials Information System) document stating the relevant authorizations. *<\/li>\n<li>Insurance policy certificate including the details of the Hospital Cl\u00ednico Universitario de Val\u00e8ncia, the INCLIVA Foundation, and the Principal Investigator (PI).<\/li>\n<li>Notarial powers of attorney of the signatory on behalf of the sponsor or the CRO and delegation to the CRO, if appliable. Duly apostilled if issued by notaries outside Spain.<\/li>\n<li>Confirmation of medication supply (if aplicable).<\/li>\n<\/ul>\n<p>*The fully signed contract will remain under the custody of the INCLIVA Foundation until the opinions and authorizations of the competent committees and administrative authorities are sent to <a href=\"mailto:contratoseecc@incliva.es\">contratoseecc@incliva.es<\/a>.<\/p>\n<p><em><br \/>\nNEGOTIATION OF THE FINANCIAL REPORT:<\/em><\/p>\n<p>According to the Main Department of the trial or study, the negotiation of the financial report will be carried out with the following contacts:<\/p>\n<ul>\n<li>Hematology: Eva Barri\u00a0<a href=\"mailto:ebarri@incliva.es\">ebarri@incliva.es<\/a><\/li>\n<li>Oncology: Enrique Castell\u00f3\u00a0<a href=\"mailto:ecastello@incliva.es\">ecastello@incliva.es<\/a><\/li>\n<li>Other Departments: Manu Erasun\u00a0<a href=\"mailto:merasun@incliva.es\">merasun@incliva.es<\/a><\/li>\n<\/ul>\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-2\" style=\"transform:translate3d(0,0,0);\"><h5 style=\"text-align: justify;\">Management of contract for observational studies<\/h5>\n<p>The sponsor must contact the email account\u00a0<a href=\"mailto:contratoseecc@incliva.es\">contratoseecc@incliva.es<\/a>\u00a0providing:<\/p>\n<ul>\n<li>Basic study information (sponsor code, Principal Investigator, and Performing Department).<\/li>\n<li>INCLIVA contract template completed:\n<ul>\n<li>Observational study with medicinal product or medical device (<a href=\"\/wp-content\/uploads\/2025\/05\/F-EG-GEns-10-v2.4-Contrato-EO-1.docx\">Spanish<\/a>\u00a0and\u00a0<a href=\"\/wp-content\/uploads\/2025\/10\/F-EG-GEns-15-v2.4-Contrato-EO-traducido.docx\">bilingual<\/a>).<\/li>\n<li>Post-authorization observational study contract of medical device with CE marking with the research center (<a href=\"\/wp-content\/uploads\/2024\/11\/F-EG-GEns-26-v1.2-Contrato-Producto-sanitario-marcado-CE.docx\">Spanish<\/a>).<\/li>\n<\/ul>\n<\/li>\n<li>General financial report of the sponsor and <a href=\"\/wp-content\/uploads\/2024\/11\/Plantilla-ME-promotor_ESP_ENG-1.xlsx\">INCLIVA financial report for the sponsor<\/a>.<\/li>\n<li>Powers of attorney of the signatory and delegation to the CRO, if aplicable, and duly apostilled if necessary.<\/li>\n<li>Approval of the CEIm.*<\/li>\n<li>AEMPS authorization when required due to the characteristics of the study.<\/li>\n<\/ul>\n<p>*The fully signed contract will remain under custody of the INCLIVA Foundation until the opinions and authorizations of the competent committees and administrative authorities are sent to <a href=\"mailto:contratoseecc@incliva.es\">contratoseecc@incliva.es<\/a>.<\/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-3\" style=\"transform:translate3d(0,0,0);\"><h5 style=\"text-align: justify;\">Addenda<\/h5>\n<p>The sponsor must contact the e-mail account\u00a0<a href=\"mailto:contratoseecc@incliva.es\">contratoseecc@incliva.es<\/a>\u00a0providing:<\/p>\n<ul>\n<li>Basic study information (sponsor code, Principal Investigator and Performing Department) and the reason or reasons for the addendum.<\/li>\n<li>INCLIVA\u2019s addendum template completed (<a href=\"\/wp-content\/uploads\/2025\/05\/F-EG-GEns-2-v2.3-Adenda-contrato.docx\">Spanish<\/a>\u00a0and\u00a0<a href=\"\/wp-content\/uploads\/2025\/11\/F-EG-GEns-14-v2.2-ADENDA-contrato-traducido.docx\">bilingual<\/a>).<\/li>\n<li>When necessary, the sponsor\u2019s general financial report and <a href=\"\/wp-content\/uploads\/2024\/11\/Plantilla-ME-promotor_ESP_ENG-1.xlsx\">INCLIVA\u2019s financial report for the sponsor<\/a>.<\/li>\n<li>If the signatory of the sponsor has changed with respect to the contract or addendum previously managed, powers of attorney of the signatory and delegation to the CRO, if aplicable, and duly apostilled if necessary.<\/li>\n<li>CEIm approval and AEMPS authorization when the characteristics of the addendum require it.*<\/li>\n<\/ul>\n<p>*The fully signed addendum will remain under the custody of the INCLIVA Foundation until the opinions and authorizations of the competent committees and administrative authorities are sent to\u00a0<a href=\"mailto:contratoseecc@incliva.es\">contratoseecc@incliva.es<\/a>.<\/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: justify;\">Exemption from contract or addendum management costs:<\/h5>\n<ul>\n<li>\n<ul>\n<li>To be able to request the exemption from the management cost of the contract or addendum under processing, the following requirements must be met:\n<ol>\n<li>That the research to be carried out is independent.<\/li>\n<li>That the sponsor of the study is a non-profit research entity, a public research entity, including healthcare centers of the Conselleria de Sanidad, or a staff researcher of the public research entities, including the healthcare centers of the Conselleria de Sanidad.<\/li>\n<li>That no external private funding has been obtained for the conduct of the study.<\/li>\n<li>That the research team will not receive any type of remuneration for its participation in the study.<\/li>\n<\/ol>\n<\/li>\n<\/ul>\n<p>The corresponding application template can be downloaded and completed\u00a0<a href=\"\/wp-content\/uploads\/2024\/11\/F-EG-GEns-29-v1-Solicitud-exencion-tasas.docx\">here<\/a>.<\/li>\n<\/ul>\n<\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-0{width:66.666666666667% !important;margin-top : 0px;margin-bottom : 20px;}.fusion-builder-column-0 > .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-0{width:66.666666666667% !important;}.fusion-builder-column-0 > .fusion-column-wrapper {margin-right : 2.88%;margin-left : 2.88%;}}@media only screen and (max-width:640px) {.fusion-body .fusion-builder-column-0{width:100% !important;}.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_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-5\" style=\"transform:translate3d(0,0,0);\"><h5 style=\"text-align: center;\">Contracts and Addenda<\/h5>\n<p style=\"text-align: center;\">Miguel Roig<\/p>\n<\/div><div style=\"text-align:center;\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\" style=\"border:2px solid #e2e2e2;border-radius:8px;width:100%;max-width:160px;margin-bottom:15px;\"><img width=\"1390\" height=\"1853\" title=\"Miguel-Reig\" src=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2023\/12\/Miguel-Reig.jpg\" class=\"img-responsive wp-image-27344\" srcset=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2023\/12\/Miguel-Reig-200x267.jpg 200w, https:\/\/www.incliva.es\/wp-content\/uploads\/2023\/12\/Miguel-Reig-400x533.jpg 400w, https:\/\/www.incliva.es\/wp-content\/uploads\/2023\/12\/Miguel-Reig-600x800.jpg 600w, https:\/\/www.incliva.es\/wp-content\/uploads\/2023\/12\/Miguel-Reig-800x1066.jpg 800w, https:\/\/www.incliva.es\/wp-content\/uploads\/2023\/12\/Miguel-Reig-1200x1600.jpg 1200w, https:\/\/www.incliva.es\/wp-content\/uploads\/2023\/12\/Miguel-Reig.jpg 1390w\" sizes=\"(max-width: 640px) 100vw, 400px\" \/><\/span><\/div><div class=\"fusion-text fusion-text-6\" style=\"transform:translate3d(0,0,0);\"><p style=\"text-align: center;\"><a href=\"mailto:contratoseecc@incliva.es\">contratoseecc@incliva.es<\/a><br \/>\nTelephone: 962542397 | Ext 542397<\/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-7\" style=\"transform:translate3d(0,0,0);\"><h5 style=\"text-align: center;\">Documents<\/h5>\n<p style=\"text-align: center;\"><a href=\"https:\/\/www.incliva.es\/wp-content\/uploads\/2025\/04\/Tarifas_web_GestionEnsayosClinicos_2025_2.pdf\" target=\"_blank\" rel=\"noopener\">Rates<\/a><\/p>\n<\/div><\/div><\/div><style type=\"text\/css\">.fusion-body .fusion-builder-column-1{width:33.333333333333% !important;margin-top : 0px;margin-bottom : 20px;}.fusion-builder-column-1 > .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-1{width:33.333333333333% !important;order : 0;}.fusion-builder-column-1 > .fusion-column-wrapper {margin-right : 5.76%;margin-left : 5.76%;}}@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><style type=\"text\/css\">.fusion-fullwidth.fusion-builder-row-1 { overflow:visible; }.fusion-body .fusion-flex-container.fusion-builder-row-1{ padding-top : 2%;margin-top : 0px;padding-right : 0px;padding-bottom : 0px;margin-bottom : 0px;padding-left : 0px;}<\/style><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":13,"featured_media":0,"parent":8453,"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\/47047"}],"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\/13"}],"replies":[{"embeddable":true,"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/comments?post=47047"}],"version-history":[{"count":10,"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/pages\/47047\/revisions"}],"predecessor-version":[{"id":47300,"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/pages\/47047\/revisions\/47300"}],"up":[{"embeddable":true,"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/pages\/8453"}],"wp:attachment":[{"href":"https:\/\/www.incliva.es\/en\/wp-json\/wp\/v2\/media?parent=47047"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}