Contract
CONTRATO DE ENSAYO CLÍNICO CON EL CENTRO DE INVESTIGACIÓN
En Valencia, a Haga clic aquí para escribir una fecha.
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Datos para la facturación de la tasa de gestión administrativa del contrato |
Datos para la facturación de visitas y pruebas del estudio |
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Se establece el siguiente desglose de pago por visitas (Véase Anexo II):
PRUEBAS EXTRAORDINARIAS (No incluidas en el precio por visita) (por protocolo fuera de la práctica clínica habitual, si están clínicamente indicadas, etc.) - Véase Anexo II
OTROS PAGOS (Fallos de selección, Puesta en marcha, Visitas extraordinarias, Preparación y envío de muestras, etc.) - Véase Anexo II
REEMBOLSO A PACIENTES - Véase Anexo II
En caso de inclusión de nuevos pacientes al ensayo, el PROMOTOR comunicará al CENTRO la modificación del protocolo y se procederá a la revisión de la memoria económica, mediante Anexo de ésta en los conceptos imputables.
El promotor Haga clic aquí para escribir texto. se compromete a facilitar a la dirección económica de la Fundación de Investigación del Hospital Clínico Universitario de la Comunidad Valenciana, INCLIVA, una vez finalizado el ensayo clínico código Haga clic aquí para escribir texto. y titulado ”Haga clic aquí para escribir texto.” una copia de la liquidación de gastos correspondientes al citado ensayo.
La Entidad Promotora hace constar que no se han establecido ni se establecerán acuerdos ajenos al presente contrato con el Investigador Principal, sus colaboradores ni con ninguna institución implicada directa o indirectamente con la realización de este Ensayo Clínico, de los que deriven retribuciones económicas adicionales o contraprestaciones en especie. En el caso de que por algún motivo sea necesaria la firma de un contrato complementario, se anexará según modelo del Anexo IV.
SEXTA. OBLIGACIONES DEL PROMOTOR DEL ENSAYO
Establecidas según la legislación vigente en materia de ensayos clínicos.
El promotor deberá informar al CEIm y a la Dirección del Centro del inicio del ensayo clínico en el centro.
El promotor deberá realizar una visita de inicio al Servicio de Farmacia para acordar los pormenores de desarrollo del ensayo clínico con medicamentos.
SEPTIMA. OBLIGACIONES DEL MONITOR
Establecidas según la legislación vigente en materia de ensayos clínicos.
OCTAVA. OBLIGACIONES DEL INVESTIGADOR PRINCIPAL
El investigador principal se responsabiliza de que el Ensayo se ajuste a los requisitos y condiciones establecidos en la autorización administrativa correspondiente, de acuerdo con las obligaciones contenidas en la legislación vigente en materia de ensayos clínicos.
NOVENA. OBLIGACIONES DEL SERVICIO DE FARMACIA
a) Mantendrá actualizado un archivo en el que se detallen los medicamentos utilizados del Ensayo hasta la finalización del ensayo, momento en el cual se podrá transferir al promotor la medicación sobrante junto al archivo maestro del ensayo, así como el control de las cantidades expedidas y las respectivas fechas de expedición.
b) Cuando así se acuerde con el promotor, se responsabilizará de que los códigos de aleatorización estén custodiados en lugar accesible en caso de urgencia.
c) Se responsabilizará del correcto manejo y conservación de la medicación, entendiendo por ello, el control en la recepción de la medicación, correcto almacenamiento, control de la dispensación y devolución al promotor de la medicación sobrante.
d) El Servicio de Farmacia será participe de la decisión de inicio de cada ensayo clínico que deba contar con su colaboración. Si el investigador no informa al Servicio de Farmacia del comienzo del ensayo, este podrá no proveer la medicación del ensayo, de forma que el contrato podrá ser rescindido.
DÉCIMA. ARCHIVO DE DOCUMENTACIÓN DEL ENSAYO CLÍNICO
a) El promotor del ensayo y el Investigador principal son responsables del archivo de la documentación del ensayo conforme a lo establecido en la legislación vigente aplicable.
b) El investigador se ocupará de que los códigos de identificación de los sujetos se conserven conforme a lo establecido en la legislación vigente aplicable.
c) Las historias clínicas de los pacientes y demás datos originales se conservarán de acuerdo a la legislación vigente.
d) El promotor o propietario de los datos conservará toda la restante documentación relativa al ensayo durante el período de validez del medicamento, según la legislación vigente en materia de ensayos clínicos y según las normas internas del centro.
e) Se documentará todo cambio que se produzca en la posesión de los datos.
f) Todos los datos y documentos se pondrán a disposición de las autoridades competentes si éstas así lo solicitan.
g) Se asegurará, en todo caso, la confidencialidad de los datos y documentos contenidos en el archivo.
h) En todo caso, las partes acuerdan que se adaptará al modelo de las normas ICH (International Conference of Harmonization Guideline) para las Buenas Prácticas Clínicas (BPC).
i) Los Comités conservarán todos los documentos esenciales, relacionados con cada ensayo clínico evaluado, conforme a lo establecido en la legislación vigente aplicable.
UNDÉCIMA. INFORMES Y PROPIEDAD DE LOS RESULTADOS
11.1.- Informes. Las partes se comprometen a colaborar e informarse recíprocamente en relación con el Ensayo, su seguimiento y los resultados del mismo, siguiendo a estos efectos las exigencias recogidas en los artículos 30 y 31 del Real Decreto 1090/2015. En el plazo de un año desde el final del ensayo, el promotor remitirá a la Agencia Española de Medicamentos y Productos Sanitarios y a los Comités Éticos de Investigación con medicamentos implicados un resumen del informe final sobre los resultados del ensayo.
11.2.- Propiedad de los resultados. Las partes acuerdan que todos los derechos, datos, resultados y descubrimientos o inventos, patentables o no, realizados, obtenidos o generados en relación con el Ensayo serán propiedad exclusiva del PROMOTOR.
En el caso de contratos con memoria económica cero, las partes acuerdan que la propiedad intelectual e industrial de los resultados derivados del presente ensayo sea compartida, en proporción a la aportación de cada una de ellas a la presente investigación. En los instrumentos de protección del conocimiento generado, se hará constar de manera expresa dicha circunstancia de co-titularidad. Los gastos derivados necesarios para la protección de dicha propiedad, serán asumidos por las partes en los mismos términos.
DUODÉCIMA. SEGUROS Y RESPONSABILIDADES
12.1.- El Promotor del presente ensayo tiene contratado un seguro de responsabilidad civil, que cubre las responsabilidades legales en los términos establecidos por la normativa de ensayos clínicos y la normativa en materia de contratación de seguros en nuestro país. El certificado de la póliza se adjunta al presente contrato en el Anexo IV.
El Promotor se compromete a mantener la cobertura del seguro durante todo el tiempo de duración del ensayo.
En el supuesto de ampliación del número de pacientes, el promotor se compromete a ampliar la cobertura del correspondiente seguro.
12.2.- En todo caso, el CENTRO acuerda notificar al PROMOTOR cada vez que tenga conocimiento de una querella, denuncia, reclamación o acción legal, real o potencial si es conocida.
DECIMOTERCERA. REPRESENTACIÓN DE LAS PARTES
El CENTRO no ostenta representación alguna del PROMOTOR frente a terceros.
El Promotor se compromete a notificar al centro, a través del Comité Ético de Investigación con medicamentos, toda modificación del protocolo surgida durante la realización del mismo, tales como ampliaciones del periodo de reclutamiento, renovación de la póliza del seguro de responsabilidad civil, renovación de la autorización de producto en fase de investigación clínica, etc…, así como el informe final de cierre del ensayo, con la relación de pacientes incluidos y el balance final de muestras (muestras utilizadas y muestras devueltas)
Ninguna información acerca de datos del ensayo podrá ser revelada por el centro o el investigador a medios de comunicación o a personal relacionado con entidades operadoras xxx xxxxxxx financiero. El Investigador Principal, en nombre propio y en el de los colaboradores, se compromete a no hacer uso en beneficio propio de la información privilegiada que su participación en el ensayo pudiera suponer.
DECIMOCUARTA. FACULTAD DE INSPECCIÓN Y SUPERVISIÓN
El CENTRO y el INVESTIGADOR PRINCIPAL y sus colaboradores y el Promotor posibilitarán a las autoridades sanitarias a inspeccionar sus Registros del ensayo y fuentes asociadas al Ensayo Clínico, cuando se solicite.
El CENTRO y el INVESTIGADOR PRINCIPAL y sus colaboradores posibilitarán al monitor designado por el PROMOTOR, inspeccionar sus Registros del estudio y fuentes asociadas al Ensayo Clínico, cuando se solicite.
DECIMOQUINTA. REGULACIÓN Y JURISDICCIÓN.
15.1.- Contractual. Las partes convienen que sus relaciones se regulan exclusivamente por el contenido del presente contrato, sin perjuicio de la regulación contenida en el Protocolo y demás documentos concordantes que se firmen en relación con este documento, siendo nulo y quedando sin efecto, cualquier acuerdo anterior, expreso o tácito, documentado o no, del que se deriven contraprestaciones económicas diferentes de las establecidas en el presente Contrato. El presente contrato sólo se entenderá modificado o enmendado por acuerdo escrito de las partes y según lo dispuesto en la estipulación 2.1.- del mismo.
15.2.- Legislativa. El presente contrato se somete a las leyes y normas españolas.
15.3.- Jurisdicción. Las partes se someten, con renuncia expresa al fuero que pudiera corresponderles, a la Jurisdicción correspondiente de la Comunitat Valenciana.
DECIMOSEXTA. CAUSAS DE SUSPENSIÓN Y TERMINACIÓN
Serán causas de terminación:
16.1.- Ordinaria. El contrato finalizará cuando concluya la realización del ensayo clínico.
16.2.- Extraordinarias. El presente contrato podrá suspenderse o terminarse en caso de que concurra alguna de las causas expuestas en el apartado 2 del artículo 59 del Real Decreto Legislativo 1/2015, de 24 de julio, por el que se aprueba el texto refundido de la Ley de garantías y uso racional de los medicamentos y productos sanitarios, o bien se podrá terminar o modificar por las siguientes causas:
Imposibilidad de incluir un mínimo de pacientes que permitan la valoración final del ensayo en un plazo razonable.
Por causa debidamente justificada.
Si se alcanza el número total de pacientes que tienen que incluirse en el ensayo por los diferentes investigadores que participan en el mismo cuando se trate de un ensayo competitivo y multicéntrico.
En caso de suspensión o de terminación anticipada del contrato, el Promotor abonará únicamente la cantidad correspondiente al trabajo realizado en función del número de visitas realizadas por los pacientes evaluables hasta ese momento.
Llegada la suspensión o terminación del ensayo el Investigador Principal y/o el Centro devolverán al Promotor el material suministrado y toda la medicación no utilizada que esté en su poder.
16.3.- La finalización del contrato conllevará la liquidación de las relaciones económicas entre las partes, sin perjuicio de la responsabilidad asegurada en el apartado duodécimo.
En caso de suspensión del ensayo, El INVESTIGADOR PRINCIPAL deberá devolver al PROMOTOR el material suministrado por éste y toda la medicación no utilizada, que continúe en su poder.
El PROMOTOR estará obligado al pago de todas aquellas prestaciones que hubieran sido realizadas hasta la fecha de la suspensión, salvo:
Al CENTRO, de aquellas prestaciones que, realizadas de forma defectuosa, hubieren originado la suspensión del ensayo.
Al INVESTIGADOR PRINCIPAL, si la suspensión derivase del incumplimiento de sus funciones y obligaciones.
El ensayo se suspenderá antes de la finalización de la fecha prevista, en la fase de ejecución en la que se encuentre, si se presenta alguna de las circunstancias siguientes:
Si de los datos disponibles se infiere que no es seguro o justificado seguir administrando el fármaco de Ensayo y/o el fármaco comparativo o el placebo a los pacientes.
Por incumplimiento del Investigador Principal de cualquiera de los términos de este contrato y/o del Protocolo.
Por acordarse la suspensión de común acuerdo entre las partes contratantes. Dicho acuerdo deberá establecerse por escrito.
En el caso de finalización anticipada, el investigador Principal entregará al Promotor un informe de los resultados obtenidos hasta el momento de la interrupción de la investigación.
En todos estos casos, el Promotor abonará al Departamento/Centro, a los sujetos del ensayo y en su caso a la Fundación, las cantidades correspondientes al trabajo correctamente realizado.
DECIMOSEPTIMA. SUSCRIPCIÓN CONTRATO
Este Contrato podrá otorgarse en uno o más ejemplares, todos los cuales se considerarán originales y constituirán, en su conjunto, un único y mismo documento.
El acuerdo podrá firmarse mediante firma electrónica no siendo necesario en este caso otorgar e intercambiar documentos con las firmas originales.
Las partes aceptan que la fecha en vigor del acuerdo sea la fecha de firma del último firmante.
CLINICAL TRIAL AGREEMENT WITH THE
RESEARCH SITE
In Valencia, Haga clic aquí para escribir una fecha.
BY AND BETWEEN
On the one hand (Site) Mr. Xxxx Xxxxxx Xxxxx Xxx as Site Manager of the Departamento Clínico Malvarrosa [Malvarrosa Clinical Department] with registered offices at the Hospital Clínico Universitario de Valencia [Valencia University Clinical Hospital] at Xxxxxxx Xxxxxx Xxxxxx, xxxxxx 00, Xxxxxxxx, and TIN number S-4611001-A.
The party of the second part (INCLIVA Foundation), Mr. Xxxxxxx de Xxxx Xxxxxx, in his capacity as Managing Director of the FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL CLÍNICO DE LA COMUNIDAD VALENCIANA [Research Foundation of the Clinical Hospital of Valencia], hereinafter Fundación INCLIVA, TIN G-96886080, with headquarters in Valencia, Avenida Xxxxxxxx Xxxxxx 4, zip code 46010, acting on behalf of the Fundación INCLIVA by delegation of powers of the Board assigned to it by the agreement dated 03MAY2022,
On the other hand (Sponsor) Mr./Ms. Haga clic aquí para escribir texto., as Haga clic aquí para escribir texto., for and on behalf of Haga clic aquí para escribir texto. with CIF No. Haga clic aquí para escribir texto. and with registered offices at Haga clic aquí para escribir texto. with legal capacity to undersign the present Agreement.
And on the other hand (Principal Investigator) Mr./Ms. Haga clic aquí para escribir texto. with D.N.I. (National Identity Card) Haga clic aquí para escribir texto., attached to the Department of Haga clic aquí para escribir texto. from the Hospital Clínico Universitario de Valencia as Principal Investigator, acting on his own behalf and in compliance with the obligations assumed.
CONSIDERING
The provisions of current Spanish legislation on clinical trials with medicinal products and medical devices and adhering to the ethical standards, Good Clinical Practice and Good Laboratory Practice applicable to the conduct of Clinical Trials.
Considering that for the purposes of this agreement the site will be considered to be Hospital Clínico Universitario de Valencia.
DECLARE
The SUBJECT of the present Agreement is the performance at the health site Hospital Clínico Universitario de Valencia of the CLINICAL TRIAL titled: “Haga clic aquí para escribir texto.” with protocol code Haga clic aquí para escribir texto. (hereinafter referred to as Protocol) sponsored by Haga clic aquí para escribir texto. and that will be directed by Dr. Haga clic aquí para escribir texto. (named Principal Investigator) of the Department of Haga clic aquí para escribir texto. from the health center Hospital Clínico Universitario de Valencia (hereinafter referred to as Site or Research Site), in accordance with the Clinical Trial Protocol with EUDRACT number Haga clic aquí para escribir texto..
That for this purpose, the SPONSOR has chosen the most suitable investigator according to its qualification and available sources for the performance, direction and supervision of the trial at the SITE facilities, in accordance with the Protocol duly approved by the relevant authorities and the approval of the Agencia Española de Medicamentos y Productos Sanitarios [Spanish Agency of Medicines and Medical Devices].
That said Trial is intended to Haga clic aquí para escribir texto. all in accordance with Protocol which describes in detail the procedures and scope of the clinical trial to be conducted.
That the trial shall be conducted after obtaining the required authorization from the Agencia Española de Medicamentos y Productos Sanitarios and the approval from the Drug Research Ethics Committee (Haga clic aquí para escribir texto.) as well as the conformity of the Manager of the Hospital Clínico Universitario de Valencia.
That based on these principles and objectives, the parties agree to enter into this agreement under the following terms and conditions:
CLAUSES
FIRST. OBJECT OF THE AGREEMENT
Subject to the present Agreement, the SITE authorizes the performance of the Clinical Trial in the facilities referred to in appendices I, II, III and IV. This Clinical Trial shall be performed, directed and supervised personally by the INVESTIGATOR to whom the researching task is expressly conferred.
On the other hand, the Clinical Trial is performed with an estimated number of Haga clic aquí para escribir texto. participating subjects and within an estimated maximum term of Haga clic aquí para escribir texto. months, as detailed in the Protocol. Said number and term can be modified when deemed necessary with the approval of the corresponding budget. Any modification of said amount shall be communicated by the sponsor to the corresponding Drug Research Ethics Committee (DREC).
The sponsor reserves the right to suspend the inclusion of patients in any of the following cases: a) If the Principal Investigator does not include the agreed upon number of patients within the designated time period, b) If the different investigatorsof a multicenter Clinical Trial include the total number of patients agreed upon in this agreementin said Clinical Trail.
SECOND. PERFORMANCE CONDITIONS
2.1. - Protocol and Good Clinical Practice (GCP).
The conditions for the performance of the Trial shall be those laid down in the current legislation, in the GCP guidelines and in the present Agreement.
The parties herein shall comply with the provisions of the Protocol, including amendments or modifications to be introduced in it provided that they have been signed and accepted by the INVESTIGATOR and the SPONSOR, which shall keep in their files copies of all the amendments and modifications made to the Protocol, prior approval of such amendments and modifications by the DREC or AEMPS [Agencia Española de Medicamentos y Productos Sanitarios],, with regard to Article 26 of Royal Decree 1090/2015, of December 4, regulating clinical trials with drugs.
2.2. - Term and duration.
This Agreement shall start on the date of its signing and shall remain valid until the end of the Trial.
The clinical trial shall start on the date on which approval is obtained from the AEMPS or on the date of the last signature of this agreement, whichever occurs later and will last approximately Haga clic aquí para escribir texto. months.
In the event that the start or the duration of the clinical trial is modified, the SPONSOR shall notify the SITE and the DREC.
2.3. - Modification.
The Protocol may not be unilaterally modified by the PRINCIPAL INVESTIGATOR; it requires prior approval and consent by the SPONSOR. Any modification to the authorized Protocol shall be notified to the relevant Ethics Committee, the Agencia Española de Medicamentos y Productos Sanitarios, and shall have the approval of the Principal Investigator of the Study.
Any modifications or amendments to the Protocol shall be notified to the SITE, through the local DREC. The site may, if such modifications or amendments are considered as essential, either terminate the agreement or by mutual agreement with the Sponsor, proceed with the renewal of the contract.
2.4.- Ethical and legal Standards.
All the parties agree to comply with current Spanish Legislation regulating Clinical Trials with Drugs: Royal Legislative Decree 1/2015, of July 24, approving the revised text of the Law on guarantees and rational use of medicines and medical devices, Royal Decree 1090/2015 of December 4, regulating clinical trials with drugs, Royal Decree 577/2013 of 26 July , regulating pharmacovigilance of drugs for human use, the Convention on 4 April, 1997 for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, (instrument of ratification on 23JUL1999) date of entry into force in Spain 01JAN2000, and other consistent rules.
Clinical trials with medical devices will be performed according to the Royal Decree 1591/2009 of 16 October, regulating medical devices and Royal Decree 1616/2009, of 26 October, regulating implantable active medical devices.
It is agreed that the aforementioned clinical trials with medical devices will be performed in accordance with the provisions of the Declaration of Helsinki and the ICH guidelines (International Conference onHarmonization Guideline) for Good Clinical Practices (GCP).
The SITE shall ensure that during the conduct of the Trial fundamental human rights are fully observed, in accordance with essential Bioethical standards, health standards and Good Clinical Practice standards applicable to the Trial, without substituting the tasks entrusted to the SPONSOR, INVESTIGATOR and Drug Research Ethics Committee.
Likewise, the following shall apply:
- Decree 17/2012, of 20 January, of the Consell [Cabinet of the Regional Government of Valencia], which amends Decree 73/2009 of 5 June, of the Consell, regulating the management of clinical trials and post-authorization observational studies with drugs and medical devices.
- Resolution issued on 16JUL2009, regulating procedures, documentation and deadlines to be observed in the presentation and modification of clinical trial-related processes and post-authorization observational studies with drugs and medical devices in the Community of Valencia.
- Resolution issued on 16JUL2009approving the agreement template to be entered into between the health center management, the sponsor and the investigators, for the conduction of a clinical trial or post-authorization observational studies with drugs and medical devices in the institutions of the health services of the Conselleria de Sanitat (Regional Health Ministry) of the Community of Valencia.
- And other issues where Law 14/2007, of 3 July, regarding Biomedical Research, can be applied.
Nothing that is established in this agreement may be in any way interpreted as constituting an obligation or inducement to prescribe, recommend, buy, use or concert the use of any product of the Sponsor or its affiliate companies.
2.5. - Patient’s Informed Consent.
Before a patient is included in a Clinical Trial, the Principal Investigator or his collaborators shall verbally and in writing inform the patient in an understandable language of the nature of the Trial and obtain the informed consent of said patient and/or their representative, in accordance with current legislation. The patient shall receive a copy of this document.
The consent shall be prior to the inclusion of the subject to the trial, and shall be dated and signed. The subjects participating in a Trial must be able to give their consent after having been duly informed about the nature, importance, implications and risk of their participation in the Trial, as well as of the alternative treatments and the confidentiality conditions under the applicable legislation on data protection, and in particular, with Regulation (EU) 2016/679 on the protection of natural persons in relation to the processing of personal data (the "General Data Protection Regulation" or " GDPR ", for its acronym in English). In the event the subject is not capable of giving consent or is unable to do so, the decision shall be made, taking into account the requirements of Royal Decree 1090/2015.
In the case of clinical trials involving minors or disabled persons, the Public Prosecutor’s Office shall be informed as provided for by the current Legislation.
The versions to be used of the Patient Information Sheet (PIS) and the Informed Consent (Form (ICF) shall be those approved by the Ethics Committee.
The DREC of the Site shall approve the Patient Information Sheet (PIS) and the Informed Consent (Form (ICF). Furthermore, the identification and electronic informed consent by the patient in the information system of the Agencia Valenciana de Salud (Valencia Regional Health Agency) will be done.
A copy of the informed consent form shall be filed with the medical history of the patient and duly kept.
If there is no electronic version of the informed consent form or it is not available, the copy of the informed consent form shall be kept in the Investigator’s file.
2.6. - Access.
The DREC shall have access at all times to the documentation of the Trial, necessary for the follow up of Clinical Trials in accordance with the current regulations, especially the informed consent of patients participating in the Trial.
The clinical trial monitor shall also have access in every visit done to the clinical documentation of patients included in the clinical trial. Nonetheless, the monitor shall respect the confidentiality of data in accordance with the current legislation.
Likewise, the competent Health Authorities and the sponsor’s monitors shall have access to the clinical documentation of the patient, when performing GCP inspections and audits.
2.7. - Publication of results.
The sponsor undertakes to publish the results of the present clinical trial. Said publication shall obligatorily be sent to the DRECs involved in the performance of the clinical trial and the principal investigators for their knowledge. The Principal Investigator shall be free to present the results in an appropriate scientific meeting and/or publish them in a prestigious magazine, undertaking to submit to the Sponsor a copy of the manuscript or original, with sufficient notice, so that the Sponsor may have the chance to review and comment on the content of such communication/publications in the term stated in the Protocol or otherwise within 30 days from receipt thereof.
The investigator undertakes to comply with the provisions of the trial protocol relating to the publication of data, undertaking not to publish/disseminate those obtained in the site, until the study data has been published as a whole.
If so requested by the Sponsor, in order to properly secure the protection of inventions or developments arising from the trial, the Principal Investigator agrees to delay the submission of the proposed publication for a period not exceeding six (6) months.
The Sponsor undertakes not to impede and/or hinder the dissemination of those results that, being scientifically sound and unquestionable, reveal the lack of efficacy or adverse effects of the treatment.
The Sponsor shall be bound to comply fully with Article 42 of publications of Royal Decree 1090/2015, of 4 December regulating clinical trials with drugs.
In the event that after nine (9) months of the presentation of the final report of the Trial to the Competent Authorities, in accordance with article 30 of the Royal Decree 1090/2015 for the performance of clinical trials with drugs, the Sponsor does not prove the initiation of the results publication process, these may be made public in the Program for Clinical Studies of Drugs and Medical Devices (Programa de Estudios Clínicos de Medicamentos y Productos Sanitarios; PECME) in the Community of Valencia (PECME) on the website of the Conselleria de Sanitat.
2.8. - Confidentiality and Data protection.
Any information relating to the conduct of the Trial, whether previous or subsequent to the same, provided or obtained, is confidential. In the event that information is disclosed to a third party, this such party undertakes in writing to maintain the secrecy and confidentiality of the information on the same terms contained herein.
This confidentiality agreement shall remain in force indefinitely after this agreement is terminated. The Principal Investigator undertakes to have all members of the research team and any third party to whom confidential information relating to this clinical trial has been disclosed will sign a confidentiality agreement with terms similar to those provided in this agreement, or their adhesion to the content of this agreement before their collaboration tasks in this study begin.
Finally, all the parties and collaborating staff shall take appropriate measures to maintain confidentiality of personal data of which they are aware as a result of the trial, preventing access to said data to unauthorized third parties. The SITE shall ensure confidentiality, and together with the PRINCIPAL INVESTIGATOR, shall restrict access to information to those necessary for the proper execution of the protocol.
To this end, the Principal Investigator shall ensure that all data for Trial Subjects has been fully disassociated, the Sponsor not having access to such personal information. Only the trial monitors and the relevant authorities shall, insofar as permitted by the informed consent form and in the exercise of their professional duties, have access to personal information.
In this sense, strict observance must be made of: Organic Law 3/2018 of 5 December regulating Personal Data Protection and Digital Rights, as well as the General Data Protection Regulation (GDPR), Law 41/2002 of 14 November, basic regulations and their rights and duties with regard to clinical information and documentation; and Law 1/2003 of 28 January regulating rights and patient information of the Regional Community of Valencia.
Provided that article 2.7 is observed, the SITE shall not be entitled to disclose or disseminate by any means the results, data or information arising directly or indirectly from the performance of the Trial not even for scientific purposes unless authorized in writing by the SPONSOR.
Personal data of the Investigator provided to the Sponsor may be stored in a file of the Sponsor. These data will allow the Sponsor to maintain the relationship with the Investigator, to send information about the products and projects of the Sponsor and may be communicated to other companies with the same purposes. The Investigator may exercise his right to access, cancellation, rectification and opposition by writing to the Sponsor.
2.9. - Filing of documentation.
Medical histories of patients will have a permanent, dynamic and fast system to identify whether a patient is participating or has participated in a clinical trial.
The DREC, shall file all the documentation relating to its operation and activity. In the event of termination of the activity, the documentation must be kept in the institution for at least three years since the completion of the last evaluated trial.
In the event any legal proceedings are initiated, documentation in paper format shall be kept until a court decision is achieved. This documentation shall be filed preferably together, in a place that will guarantee the confidentiality of information during the time it is required to be filed.
Relevant documentation shall be stored in secure places that guarantee that the documents remain complete and legible and shall be available to the competent authorities in case they are requested during the period provided for storage.
When essential documents are stored in electronic format it must be guaranteed that any modification to the records is traceable, allowing access to the initial and corrected data, as well as the date and signature of the author, including at least the following:
Accreditation resolutions and further amendments.
Curriculum Vitae of current members or from those who have belonged to the Committee.
Meeting announcements and minutes of the Committee
Standard operating procedures of the Committee, current version and historical file.
Record book.
THIRD. PARTICIPANTS AND CONDUCTION SITE
3.1. - Participants.
3.1.1. – Sponsor.
3.1.2. - Principal Investigator. The PRINCIPAL INVESTIGATOR shall ensure that all trial participants and especially, the collaborators faithfully meet all the requirements set forth in this agreement and its appendices, after being duly informed of the same.
3.1.3. - Collaborators.
3.1.3.1-. Collaborative team.
The INVESTIGATOR’S research team, which shall be composed of staff who assist him in conducting the trial, must be approved by the DREC and be qualified to successfully carry out the planned clinical trial, complying with the requirements of the suitability certificate in appendix III.
The Principal Investigator shall notify the DREC and the Management of the Site all the modifications and updates of the tasks of the team involved in the agreement.
3.1.4.- Other staff: If for the conduction of the present clinical trial staff unrelated to the SITE is required to be hired, it shall be notified to the SITE for inspection and access authorization purposes and participation in the protocol by means of the appropriate accreditation.
None of the requirements of this agreement constitutes an employment relationship between the SITE and the hired staff unrelated to the SITE participating in the trial.
3.1.5. - Monitor: The Sponsor, in compliance with Royal Decree 1090/2015 of December 4, appoints as monitor of the Trial Mr./Ms. Haga clic aquí para escribir texto. of the company Haga clic aquí para escribir texto. (as applicable).
In the event the monitor is replaced, the Sponsor shall notify the identity of the new appointed monitor.
3.2. - Site of conduct.
The clinical trial subject to this agreement shall be conducted in the Haga clic aquí para escribir texto. Unit/Department of the Hospital Clínico Universitario de Valencia.
FORTH. FURNISHING OF PRODUCT AND EXTRAORDINARY EQUIPMENT
4.1. – Product.
The SPONSOR undertakes to provide through the Pharmacy Department (in the case of clinical trials with drugs) or the Supplies Department (in the case of medical devices), the products for the conduction of the Trial, with no cost for the site as provided in article 39 of Royal Decree 1090/2015; in exceptional circumstances and after written consent is obtained, other routes of supply and financing may be used. Said product may not be used, marketed or supplied to any third party without prior written consent by the SPONSOR.
In the event that after the conduction of the Trial there is product left over, the INVESTIGATOR and the Site shall be bound to promptly return it to the SPONSOR. For this purpose, the Site shall take the necessary measures for such restitution. After the completion of the Clinical Trial, the Sponsor shall agree with the Site on the withdrawal, destruction or transfer procedures of the surplus product (if they are marketed products), in accordance with Chapter II of Royal Decree 1015/2009, regulating the availability of drugs in special conditions.
4.2. – Equipment.
In the event that extraordinary equipment is required for the performance of the Protocol, this shall be purchased and installed by the SPONSOR, with the authorization and supervision of the Site. Moreover, the SPONSOR shall be liable for the maintenance expenses for the duration of the trial. Upon completion of the Protocol, the Sponsor is entitled to withdraw the extraordinary equipment at its sole cost. In the case of transfer of machinery by the Sponsor, the appropriate contract execution shall be made.
In the present Trial the equipment shall be the following: Haga clic aquí para escribir texto.
4.3. – Additional Tests.
The tests to be carried out on to the patients in the Site in order to carry out the Trial, that are not part of routine clinical practice during their stay at the Site, shall be borne by the Sponsor, who will be invoiced in accordance with appendix II.
These tests are not included in the price per visit.
FIFTH. ECONOMIC RELATIONS
The financial statement for the clinical trial shall specify the following sections:
5.1. Budget and financial statement.
According to the financial statement enclosed as appendix II herein: the initial budget of the trial shall contain all the payments to be made, namely, payments to the SITE AND FOUNDATIONS, (clinical trial management, direct and indirect costs), to the research team and patients and shall be broken down in the following sections:
I. Extraordinary costs for the site and patients:
I.a. Administrative management of clinical trial.
I.b. Compensation to Institution.
I.c. Compensation to patients (as applicable).
II. Regular costs of the trial (recruited patient):
II.a. Indirect costs (at least 20% of the established budget for each recruited patient).
II.b. Compensation for Investigator and collaborators
Principal Investigator and Collaborators
Haga clic aquí para escribir texto. Department
Compensation for other departments
Other staff costs
II.c. Compensation to the Pharmacy Department, in the case of Clinical Trials, and others
III. Patients not completing the study.
5.1.1. – Extraordinary costs for the site and patients
a) For the payment of administrative management of the clinical trial, the amount of 500,00 € + VAT shall be paid. The payment to the SITE shall be made upon presentation of the corresponding invoice no later than sixty (60) days from the signing of the compliance document of the management of the site, and before the start of the study to the following address and bank account:
La Caixa: XX0000000000000000000000
b) Extraordinary direct costs of the site shall cover all those specific tests and materials necessary for the conduction of the trial. Extraordinary direct costs shall be specified in detail by the PRINCIPAL INVESTIGATOR in Appendix II being accepted by the SPONSOR and the SITE. Extraordinary costs of the site shall be invoiced to the Sponsor, taking as reference the rates established in the (Tax-rate Law of the Government of Valencia for the Invoicing of Health Services, of the Agencia Valenciana de Salud, or else, for the cost of the same.
c) Compensation to patients. Where appropriate, due to the participation in the clinical trial, and as agreed with the Sponsor, patients shall be paid the amount budgeted in Appendix II.
5.1.2. – Ordinary costs of the trial (recruited patient).
Refer to Appendix II
5.2. – Financial Report
The overall financial cost of the clinical trial is contained in the Appendix II herein (Financial report of the clinical trial), where both direct and indirect costs of the trial are specified (economic compensation to investigators, administration and management expenses, expenses of the site in tests and processes, economic compensation to trial subjects, and other expenses).
In the event that a patient, for whatever cause, withdraws from the clinical trial before the trial is concluded, the Sponsor shall be bound to pay the prorated amount based on their participation in the study. To said amounts, the corresponding VAT shall be assessed, as applicable, and these shall be paid by the Sponsor in accordance with clause 5.1.2 herein.
In case of early termination of the trial for whatever reason, the amount to be paid shall be modified proportionally based on the number of patients included and how long they have participated in the trial.
5.3. – Payment methods
The sponsor shall pay the Foundation, as the entity managing the trial, the amounts mentioned in sections I, II and III of the financial report.
Payment shall be made by bank transfer to the following account XX0000000000000000000000 within 60 days of the submission date of the corresponding invoice issued by the Foundation, whose amounts shall be subject to the corresponding VAT. 100% will be paid for each invoice issued.
ADDITIONAL INFORMATION
Data for the invoice of the administrative management of the agreement |
Data for the invoice of visits and study tests |
|
|
The following breakdown of payments per visit is established (Refer to Appendix II):
EXTRAORDINARYTESTS (Not included in the price per visit) (required by the protocol and falling outside of common clinical practice, if clinically indicated, etc.)- Refer to Appendix II
OTHER PAYMENTS (screening failures, startup costs extraordinary visits, preparation and shipment of samples, etc.) - Refer to Appendix II
REIMBURSEMENT to patients - Refer to Appendix II
If new patients are recruited to the trial, the SPONSOR shall notify the SITE of the amendment to the protocol and the financial report shall be revised by means of an Appendix to the same stating the updated items.
The sponsor Haga clic aquí para escribir texto. agrees to deliver to the financial management of the Fundación de Investigación del Hospital Clínico Universitario de la Comunidad Valenciana, INCLIVA, once the clinical trial with code Haga clic aquí para escribir texto. and titled ”Haga clic aquí para escribir texto.” is concluded, a copy of the statement of expenses corresponding to said trial.
The Sponsor Entity states that no other agreements have been or will be executed with the Principal Investigator, his collaborators or any other institution involved directly or indirectly with the conduction of the present Clinical Trial, from which additional economic payments or considerations in kind result. In the event that for any reason the execution of an additional agreement is necessary, it shall be attached in accordance with the template of Appendix IV herein.
SIXTH. DUTIES OF THE TRIAL SPONSOR
Those referred to in the current legislation regarding clinical trials.
The sponsor shall notify to the DREC and the Site Management of the start of the clinical trial in the site.
The sponsor shall conduct startup visit to the Pharmacy Department in order to agree on the details of the conduction of the clinical trial with drugs.
SEVENTH. DUTIES OF THE MONITOR
Those referred to in the current legislation regulating clinical trials.
EIGHTH. DUTIES OF THE PRINCIPAL INVESTIGATOR
The Principal Investigator shall ensure that the trial meets the requirements and conditions laid down in the corresponding administrative authorization, in accordance with the obligations set forth in the current legislation regulating clinical trials.
NINTH. DUTIES OF THE PHARMACY DEPARTMENT
a) To keep updated a file in which the Trial drugs used shall be detailed until the termination of the Trial. Upon termination of the trial, any remaining medication of the trial, master file, and the control of the provided quantities and the respective issue dates can be transferred to the Sponsor.
b) If agreed with the sponsor, the Pharmacy Department of Pharmacy shall ensure that the randomization codes are kept in an accessible place in case of emergency.
c) It shall be accountable for the correct handling and conservation of the medication, that is to say: control in the reception of the drug, correct storage, drug dispensing and return to the sponsor of the remaining medication.
d) The Pharmacy Department shall take part in the decision of starting any clinical trial requiring their collaboration. If the investigator does not notify the Pharmacy Department of the start of the trial, this may not provide the trial drug, and therefore, the agreement may be cancelled.
TENTH. CLINICAL TRIAL DOCUMENTATION FILE
a) The trial sponsor and the Principal Investigator are accountable for the trial documentation file in accordance with the current applicable legislation.
b) The investigator shall ensure that identification codes of subjects are kept in accordance with the provisions of current applicable legislation.
c) Medical histories of patients and other original data shall be kept in accordance with the current legislation.
d) The sponsor or data owner shall keep the remaining trial-related documentation during the period of validity of the drug according to the current legislation regulating clinical trials and the internal rules of the site.
e) Any change in relation to data ownership shall be documented.
f) All data and documents shall be made available to the competent authorities at their request.
g) Confidentiality of data and documents contained in the file shall be ensured at all times.
h) In all cases, the parties agree to adapt to the ICH guidelines (International Conference on Harmonization Guideline) for Good Clinical Practices (GCP).
i) The Committees shall keep all the essential documents related with each clinical trial, in accordance with the provisions of current applicable legislation.
ELEVENTH. REPORTS AND OWNERSHIP OF RESULTS
11.1. – Reports. The parties agree to cooperate and reciprocally inform of any issues relating to the Trial, its follow-up, and the results arising from the same, abiding by Articles 30 y 31 of the Royal Decree 1090/2015. Within one year after the termination of the trial, the Sponsor shall send a summary of the final report concerning the trial results to the Agencia Española de Medicamentos y Productos Sanitarios and the involved Clinical Research Ethics Committees.
11.2. – Ownership of results. The parties agree that all rights, data, results and discoveries or inventions, patentable or not, made, obtained or generated in connection with the Trial shall be the exclusive property of the SPONSOR.
In the case of agreements that have a zero sum financial report, the parties agree that the intellectual and industrial property of the results arising from the trial herein shall be shared, in proportion to the contribution of each of the parties to the research herein., This circumstance of co-ownership shall be expressly stated in the instruments of protection of the knowledge generated. The necessary expenses arising from the protection of such property shall be borne by the parties in the same terms.
TWELFTH. INSURANCE AND LIABILITY
12.1.- The Sponsor of the present trial has taken out a civil liability insurance policy that covers legal responsibilities in the legal terms set forth in the clinical trials regulations and the rules for insurance contracts in our country. The insurance policy certificate is attached to this agreement as Appendix IV.
The Sponsor agrees to maintain insurance coverage throughout the duration of the trial.
In the event of including more patients, the sponsor agrees to extend the corresponding insurance coverage.
12.2.- In all cases, the SITE agrees to notify the SPONSOR whenever it receives a complaint, claim, or legal action, actual or potential if known.
THIRTEENTH. REPRESENTATION OF THE PARTIES
The SITE holds no representation of the SPONSOR towards third parties.
The Sponsor agrees to notify the site, through the Clinical Research Ethics Committee of any modification to the protocol arisen from the performance of the same, such as extensions of the recruitment period, renewal of the civil liability insurance policy, renewal of the authorization of the investigational medicinal product, etc., as well as the final report upon trial termination, containing the number of included patients and the final number of samples (used samples and returned samples).
No information about the trial data may be disclosed by the site or the investigator to the media or any staff associated with entities operating in the financial market. The Principal Investigator, on his own behalf and on behalf of his collaborators, undertakes not to use privileged information from his participation in the trial for his own benefit.
FOURTEENTH. AUDITS AND MONITORING INSPECTIONS
The SITE and the PRINCIPAL INVESTIGATOR and their collaborators and the Sponsor shall enable health authorities to inspect their trial Records and Clinical Trial-related sources, upon request.
The SITE and the PRINCIPAL INVESTIGATOR and its collaborators shall enable to the monitor appointed by the SPONSOR, to inspect their study Records and Clinical Trial-related sources, upon request.
FIFTEENTH. REGULATION AND JURISDICTION
15.1. - Contractual. Both parties agree that their relations are governed exclusively by the contents of this agreement, without prejudice to the regulations contained in the Protocol and any other concordant documents signed in relation to this document, and any other prior agreement shall be declared null and void, express or tacit, documented or not, from which financial consideration other than what is established in this Agreement arises. The present agreement shall be considered modified or amended only by written agreement of the parties and as set forth in section 2.1 herein.
15.2. - Legislative. The present agreement is subject to the Spanish Laws and regulations.
15.3. - Jurisdiction. To the extent permitted by law, the parties, with express waiver of any other jurisdiction to which they might have recourse, agree to submit to the jurisdiction of the Community of Valencia.
SIXTEENTH. GROUNDS FOR SUSPENSION AND TERMINATION
The following shall be grounds for termination:
16.1.- Ordinary. The agreement terminates upon completion of the Clinical Trial.
16.2.- Extraordinary. This agreementmay be cancelled or terminated in the event that any of the causes stated in section 2 of article 59 of Royal Legislative Decree 1/2015, of July 24, approving the revised text of the Law on guarantees and rational use of medicines and medical devices. Moreover, it may be terminated or modified for the following causes:
Failure to include a minimum number of patients that allows for the final assessment of the trial in a reasonable time.
Duly justified cause
If the total number of patients to be included in the trial by different Investigators participating in the same in a competitive and multicentertrial is achieved.
In case of cancelation or early termination of the agreement, the Sponsor will pay only the amount corresponding to the work effectively carried out based on the number of visits made byevaluable patients so far.
Once the trial is suspended or terminated, the Principal Investigator and/or the Site shall return to the Sponsor the supplied material and any unused medication in their possession.
16.3. - Conclusion of the Agreement. The conclusion of the agreement entails the liquidation of the economic relations between the parties, notwithstanding the ensured liability in clause 12 herein.
In the event the trial is suspended, the PRINCIPAL INVESTIGATOR shall return to the SPONSOR all the material provided by the latter and any unused medication that remains in his possession.
The SPONSOR shall be bound to pay for all the services carried out up to the date of termination, except for:
To the SITE, those services that were performed defectively, having caused the suspension of the trial.
To the PRINCIPAL INVESTIGATOR, if the suspension arises from the breach of his duties and obligations.
The Clinical Trial may be suspended before its estimated completion date, during whatever phase it is currently in, if any of the following circumstances occur:
If available data suggests that continuing to administer to the study drug and/or the comparative drug or the placebo to the patients is not safe or justified.
Due to failure by the Principal Investigator to comply with any of the terms set forth in the present agreement and/or Protocol.
If the contracting parties come to mutual agreement, expressed in writing, to suspend the trial.
In the case of early termination, the Principal Investigator shall hand over to the Sponsor a report of the results obtained up to the date of termination of the research.
For all the aforesaid, the Sponsor shall reimburse the Department/Site, the trial subjects and the Foundation if applicable the amounts corresponding to the work effectively carried out.
SEVENTEENTH. CONTRACT SUBSCRIPTION
This Contract may be executed in one or more copies, all of which will be considered original and will constitute, as a whole, a single and same document.
The Contract may be signed by electronic signature, not being necessary in this case to grant and exchange documents with the original signatures.
The parties accept that the effective date of the agreement is the date of last signatory.
ANEXO I / APPENDIX I
MEMORIA TÉCNICA/ TECHNICAL REPORT
DATOS DE IDENTIFICACIÓN DEL ENSAYO CLÍNICO:
CLINICAL TRIAL IDENTIFICATION DATA:
Título ensayo clínico/ Clinical Trial Title:
“Haga clic aquí para escribir texto.”
“Haga clic aquí para escribir texto.”
Promotor/ Sponsor: Haga clic aquí para escribir texto.
Investigador Principal/ Principal Investigator: Haga clic aquí para escribir texto.
Código de Protocolo/ Protocol Code: Haga clic aquí para escribir texto.
Nº EUDRACT/ EUDRACT No: Haga clic aquí para escribir texto.
Versión del Protocolo/ Protocol Version: El Ensayo se realizará, en todo momento, conforme a la última versión del Protocolo debidamente aprobada por las autoridades pertinentes. The trial will always be performed according to the latest version of the Protocol duly approved by the relevant authorities.
Versión de la Hoja de Información al Paciente y Consentimiento Informado/ Patient Information Sheet and Informed Consent Version: El Ensayo se realizará, en todo momento, conforme a la última versión de la Hoja de Información al Paciente y del Consentimiento Informado debidamente aprobados por las autoridades pertinentes. The trial will always be performed according to the latest version of the Patient Information Sheet and Informed Consent duly approved by the relevant authorities.
CEIm / DREC: Haga clic aquí para escribir texto.
Fecha de Aprobación CEIm/ DREC Approval Date: El ensayo no se realizará sin la obtención de la preceptiva aprobación. The trial shall be conducted after obtaining the required approval.
XXXXX XX/ APPENDIX II
MEMORIA ECONÓMICA / FINANCIAL STATEMENT
Todos los pagos se realizarán Haga clic aquí para escribir texto. a las instituciones especificadas más abajo, en el plazo máximo de 60 días desde la presentación de la correspondiente factura correctamente emitida al PROMOTOR en función de las visitas efectivamente realizadas, tras la entrega de los formularios totalmente cumplimentados y después de haber superado el control de calidad realizado por el Promotor. Se abonará el 100% por cada factura emitida.
All payments shall be made Haga clic aquí para escribir texto. to the institutions specified below, within a maximum period of 60 days as of the submission of the invoice properly issued to the SPONSOR based on visits actually carried out, after the delivery of the fully completed forms and after passing the quality control performed by the Sponsor. 100% will be paid for each invoice issued.
PRESUPUESTO TOTAL DEL ENSAYO: TOTAL BUDGET OF THE TRIAL: |
COSTE POR PACIENTE / COST PER PATIENT |
TOTAL Haga clic aquí para escribir texto. PACIENTES/ PATIENTS |
|
X. |
Xxxxxx extraordinarios al centro y a pacientes Extraordinary costs to the site and patients |
0,00-€ |
500,00-€ |
|
I.a. Gestión administrativa ensayo clínico I.a. Administrative management of xxxxxxxx xxxxx |
0x,00x-€ |
500,00.-€ |
I.b. Compensación a la Institución (pruebas extraordinarias) I.b. Compensation to the Institution (extraordinary tests) |
0,00-€ |
0,00-€ |
|
I.c. Compensación a los pacientes (si procede) I.c. Compensation to patients (if applicable) |
0,00-€ |
0,00-€ |
|
II. |
Costes ordinarios del ensayo (paciente reclutado) Ordinarycosts of the trial (recruited patients) |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto.-€ |
|
II.x. Xxxxxx indirectos/ II.a. Indirect Costs (20% del paciente) / (20% of the patient) [budget] |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto.-€ |
|
II.b. Compensación para Investigador, Colaboradores y Servicio II.b. Compensation to Investigator, Collaborators and Department |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto.-€ |
|
Investigador principal y colaboradores (cantidad no superior al 45% de la aportación total por paciente)
Principal investigator and collaborators (Amount not exceeding 45% of the total amount per patient) |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto. -€ |
|
Servicio de Haga clic aquí para escribir texto. (cantidad calculada mediante la diferencia entre el importe total por paciente y los gastos consignados en el resto de los apartados)
Haga clic aquí para escribir texto. Department (Amount calculated by the difference between the total amount per patient and the expenses recorded in the rest of the sections) |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto. -€ |
|
Compensación a otros servicios Compensation for other departments |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto. -€ |
|
Otros costes de personal Other staff costs |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto. -€ |
|
II.c. compensación para el servicio de farmacia, en caso de ensayos clínicos, y otros II.c. Compensation to the Pharmacy Department, in the case of Clinical Trials, and others |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto. -€ |
|
Servicio de Farmacia (cantidad equivalente al 8% de la retribución al estudio clínico por paciente)
Pharmacy Department (Amount equivalent to 8% of the remuneration to the clinical study per patient) |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto. -€ |
|
Servicio de Laboratorio (cantidad equivalente al 4% de la retribución al estudio clínico por paciente)
Laboratory Department (Amount equivalent to 4% of the remuneration to the clinical study per patient) |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto. -€ |
III. |
Pacientes que no finalizan el estudio Patients not completing the xxxxx |
0x,00x -€ |
0,00 -€ |
TOTAL PRESUPUESTO ENSAYO TOTAL BUDGET OF THE TRIAL |
Haga clic aquí para escribir texto. -€ |
Haga clic aquí para escribir texto. -€ |
|
ESTAS CANTIDADES NO INCLUYEN IVA/ THESE AMOUNTS DO NOT INCLUDE VAT
Se establece el siguiente desglose de pago por visitas:
The following breakdown of payments per visit is established:
Haga clic aquí para escribir texto.
PRUEBAS EXTRAORDINARIAS (No incluidas en el precio por visita) (por protocolo fuera de la práctica clínica habitual, si están clínicamente indicadas, etc.)
EXTRAORDINARYTESTS (Not included in the price per visit) (required by the protocol and falling outside of common clinical practice, if clinically indicated, etc.)
Haga clic aquí para escribir texto.
OTROS PAGOS (Fallos de selección, Puesta en marcha, Visitas extraordinarias, Preparación y envío de muestras…)
OTHER PAYMENTS (screening failures, startup costs, extraordinary visits, preparation and shipment of samples ..., etc.)
Haga clic aquí para escribir texto.
REEMBOLSO A PACIENTES/ REIMBURSEMENT to patients
Haga clic aquí para escribir texto.
InformaciOn Adicional / ADDITIONAL INFORMATION
Datos para la facturación de la tasa de gestión administrativa del contrato / Data for the invoice of the administrative management of the agreement |
Datos para la facturación de visitas y pruebas del estudio / Data for the invoice of visits and study tests |
|
|
XXXXX XXX / APPENDIX III
RELACIÓN DEL EQUIPO INVESTIGADOR/ RESEARCHTEAM LIST
Promotor / Sponsor: Haga clic aquí para escribir texto.
Título / Title:
“Haga clic aquí para escribir texto.”
“Haga clic aquí para escribir texto.”
Código de protocolo/ Protocol Code: Haga clic aquí para escribir texto.
Dr. Haga clic aquí para escribir texto. del Servicio de Haga clic aquí para escribir texto., Investigador principal del estudio
Dr. Haga clic aquí para escribir texto. of the Department of Haga clic aquí para escribir texto., Principal Investigator of the study,
Hace constar/ Herein states:
|
|
Nombre y apellidos / Name and surname: Haga clic aquí para escribir texto.
D.N.I. / D.N.I (National Identity Card): Haga clic aquí para escribir texto.
Categoría profesional / Professional category: Haga clic aquí para escribir texto.
Centro-Organismo / Site-Institution: Haga clic aquí para escribir texto.
Servicio / Department: Haga clic aquí para escribir texto.
Función a realizar / Tasks to be performed: Haga clic aquí para escribir texto.
Dedicación (horas.) / Dedication (hours.): según Protocolo / according to Xxxxxxxx x
XXXXX XX/ APPENDIX IV
DOCUMENTACIÓN COMPLEMENTARIA / ADDITIONAL DOCUMENTATION
Adjuntar la documentación complementaria a este anexo en caso de que por algún motivo sea necesaria la firma de un contrato complementario/
Additional documentation should be attached to this appendix in the event that for any reason the signing of an additional agreement is required.
Documento 1 Certificado póliza del seguro
Document 1 Insurance policy certificate
Documento 2 Acuerdo de tratamiento de datos personales
Document 2 Personal Data Processing Agreement
Documento 3 Acuerdo de procesamiento de muestras Biobanco INCLIVA
Document 3 Sample Processing Agreement – Biobank INCLIVA
Documento 4 Haga clic aquí para escribir texto.
Document 4 Haga clic aquí para escribir texto.
Documento 5 Haga clic aquí para escribir texto.
Document 5 Haga clic aquí para escribir texto.
Documento 1 Certificado póliza del seguro
Document 1 Insurance policy certificate
Documento 2 Acuerdo de tratamiento de datos personales
Document 2 Personal Data Processing Agreement
I.- PARTES INVOLUCRADAS EN EL TRATAMIENTO DE DATOS:
El Hospital actúa como responsable del tratamiento de las historias clínicas de los pacientes con fines asistenciales. Este tratamiento se lleva a cabo en aplicación del artículo 6.1.c del REGLAMENTO (UE) 2016/679 DEL PARLAMENTO EUROPEO Y DEL CONSEJO de 27 xx xxxxx de 2016 relativo a la protección de las personas físicas en lo que respecta al tratamiento de datos personales y a la libre circulación de estos datos (en adelante, RGPD o Reglamento General de Protección de Datos) y está amparado por la previsto en la Ley 14/1986, de 25 xx xxxxx, General de Sanidad, Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica y resto de normativa del sector sanitario.
El Promotor actúa como responsable del tratamiento de los datos recogidos para el Estudio, y en particular de los datos codificados del mismo, según la normativa de aplicación mencionada en el párrafo precedente.
El Investigador Principal designado por el Hospital es responsable de la realización práctica del Estudio clínico.
En la realización del Estudio, actúan terceras entidades por cuenta de cada uno de los responsables del tratamiento. Estas entidades tendrán la consideración de sus encargados del tratamiento de acuerdo con lo regulado en el artículo 28 del RGPD y el artículo 33 de la Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales (en adelante, LOPDGDD).
Estas entidades no tienen acceso a los datos personales para fines propios, sino que los tratan exclusivamente siguiendo las instrucciones de los responsables del tratamiento respectivos.
II.- OBJETO DEL PRESENTE ANEXO
El presente Anexo tiene por objeto establecer el marco en el que el Hospital y el Promotor, como responsables respectivos del tratamiento de los datos de los pacientes participantes en el Estudio correspondiente y en el ejercicio de las funciones que les son propias, determinan el tratamiento de datos personales realizado a través de la recogida de información clínica del Estudio en cumplimiento con los requisitos legales.
III.- FINALIDAD DEL TRATAMIENTO DE DATOS
El tratamiento de datos regulado a través del presente Anexo tiene como finalidad la realización del Estudio que se llevará a cabo conforme a lo estipulado en el RGPD, la LOPDGDD, el Reglamento (UE) n.º 536/2014 del Parlamento Europeo y del Consejo, de 16 xx xxxxx de 2014, sobre los Ensayos clínicos de medicamentos de uso humano y normativa de desarrollo, el Protocolo y el contrato principal del Estudio. En este sentido, las entidades participantes se comprometen a que el tratamiento de datos se realizará únicamente para y por las necesidades del Estudio.
Así mismo, las siguientes entidades encargadas del tratamiento efectuarán el tratamiento de datos por cuenta de las entidades responsables con las siguientes finalidades:
Estas entidades, así como cualquier otra que tenga la condición de encargada del tratamiento, se regirán por lo estipulado en sus respectivos contratos que deberán en todo caso respetar las previsiones del presente acuerdo y del artículo 28 del GDPR, en particular, no contratarán a otro encargado de tratamiento sin la autorización previa del responsable respectivo y sin un acuerdo escrito como se establece en el artículo 28.2 y 28.4 del GDPR;
IV.- GARANTÍAS APORTADAS POR LAS PARTES
Todas las partes participantes en el presente Estudio declaran que tanto ellas como los encargados de tratamiento designados ofrecen garantías suficientes para aplicar las medidas técnicas y organizativas apropiadas, de manera que el tratamiento de datos sea conforme con los requisitos del RGPD y otras leyes aplicables en materia de Protección de Datos, y garantice la protección de los derechos de los interesados.
A estos efectos, cada una de las entidades participantes manifiestan que:
Delegado de Protección de Datos de la Generalitat Valenciana Xxxxx xx xx Xxxxxxx, 00. 00000 Xxxxxxxx
Haga clic aquí para escribir texto.
V.- CONDICIONES RELATIVAS AL TRATAMIENTO
Las entidades intervinientes en el Estudio realizarán el tratamiento de datos conforme a la normativa aplicable, códigos de buenas prácticas, el Protocolo de investigación y cualquier otro en materia de investigación y protección de Datos de carácter Personal.
Cada encargado deberá informar inmediatamente a su respectivo Responsable si, en su opinión, una instrucción infringe cualquier regulación de protección de datos aplicable.
Sin perjuicio de los artículos 82, 83 y 84 del RGPD, si un encargado infringe las disposiciones del RGPD al determinar las finalidades y los medios del tratamiento, este encargado se considerará un responsable con respecto a ese tratamiento.
Así mismo, cada una de las entidades participantes se comprometen al tratamiento de Datos Personales de acuerdo con las siguientes directrices:
Es el Responsable del tratamiento de los datos relativos al Estudio, y en particular de los datos codificados de los pacientes participantes en el mismo. En el desarrollo de sus funciones realizará el tratamiento según las siguientes condiciones:
El Hospital (a través del investigador principal) es responsable de la realización práctica del Estudio, y como tal, del tratamiento de datos siguiendo las siguientes condiciones:
VI.- DEBER DE COLABORACIÓN
a) Con carácter general, las entidades participantes colaborarán entre ellas en el cumplimiento del RGPD y resto de normativa aplicable, poniendo a disposición del resto de entidades, según la normativa de aplicación y los distintos roles de las partes, la información necesaria para facilitar y demostrar su cumplimiento.
b) El Investigador principal colaborará con el promotor o entidad en la que delegue (monitor) para que pueda ejercer sus funciones relacionadas con el aseguramiento de que el Estudio se está realizando conforme a lo exigido en la normativa de aplicación y el protocolo, incluyendo la comprobación de las medidas de seguridad adoptadas, para lo que podrá realizar cuantas comprobaciones o auditorías considere necesarias pudiendo acceder a datos personales identificativos con esta finalidad.
En ningún caso, el promotor o monitor podrán obtener copia de información o documentos que contengan datos que puedan identificar directamente a los sujetos del Estudio.
c) En el caso de que cualquiera de las entidades participantes tenga sospechas de incumplimiento de la normativa de protección de datos personales, dentro de las 24 horas posteriores a su conocimiento, lo comunicarán al resto de entidades y a sus delegados de protección de datos, como corresponda según las circunstancias del caso, que determinarán qué partes deben intervenir en la investigación de los hechos.
d) Así mismo, las entidades participantes, en relación con el tratamiento de datos derivado del Estudio, se comprometen a informar al resto de entidades de:
VII.- EJERCICIO DE DERECHOS DE LAS PERSONAS INTERESADAS
El ejercicio de los derechos regulados por la normativa sobre protección de datos y la retirada del consentimiento al tratamiento de los datos serán ejercidos ante el investigador principal quien tiene la obligación de informar al responsable del tratamiento (si es necesario de forma pseudoanonimizada) correspondiente para su resolución en el tiempo y la forma legalmente establecidas.
En el caso de que un sujeto participante en el Estudio ejerza sus derechos ante una entidad o persona distinta del investigador principal esta entidad o persona deberá instruir al sujeto a que contacte con el investigador principal del Estudio.
VIII.- COMUNICACIÓN DE BRECHAS DE SEGURIDAD
Serán los respectivos responsables del tratamiento, el promotor y el hospital, quienes deban dar cumplimiento al deber de notificación en los casos en que se produzca alguna brecha o violación de la seguridad de los datos personales cuando reúna las circunstancias que determinen la necesidad de su comunicación a la autoridad de control.
IX.- TRANSFERENCIAS INTERNACIONALES
En el caso de que el Estudio requiera la realización de transferencias internacionales de datos a países que estén fuera del Espacio Económico Europeo deberá cumplirse y aportar garantías de cumplimiento del régimen jurídico establecido para las mismas en el RGPD y la LOPDGDD. A estos efectos, se entiende que existen garantías para la realización de transferencias internacionales cuando:
En el resto de casos, queda prohibida las transferencias internacionales de datos salvo que sean autorizadas por la autoridad de control competente.
X.- INFORMACIÓN A LAS PERSONAS FIRMANTES Y EQUIPO DE INVESTIGACIÓN
Los datos personales facilitados para la firma del presente contrato (“Datos Contractuales”) y la gestión del Estudio serán tratados de conformidad con el reglamento (ue) 2016/679 del Parlamento Europeo y del Consejo de 27 xx xxxxx de 2016 relativo a la protección de las personas físicas en lo que respecta al tratamiento de datos personales y a la libre circulación de estos datos y por el que se deroga la directiva 95/46/CE (RGPD) y la Ley Orgánica 3/2018, de 5 de diciembre, de Protección de Datos Personales y garantía de los derechos digitales (LOPDGDD).
Los datos del investigador y del personal del estudio serán tratados por el Promotor como se indica en “Aviso de privacidad para el equipo investigador estudio clínico”, que se proporcionó (o se proporcionará) al Hospital / investigador principal y a todos los investigadores principales, subinvestigadores y personal de investigación actuales y futuros.
Los Datos Contractuales serán tratados con fundamento en las siguientes condiciones:
Todo ello, en relación con lo establecido en el Real Decreto 1090/2015, de 4 de diciembre, por el que se regulan los Estudios clínicos con medicamentos, los Comités de Ética de la Investigación con medicamentos y el Registro Español de Estudios Clínicos.
Puede acceder a la guía del procedimiento en la siguiente dirección: Guía procedimiento: xxxxx://xxx.xxx.xx/xx/xxxxxx/xxxxxxxxxxxxxx?xx_xxxxx00000&xxxxxxxxxxx
Xx. Xx xx Xxxxxxx, 00. 00000 Xxxxxxxx Dirección de correo electrónico: xxx@xxx.xx
XI.- RESPONSABILIDAD
Cada una de las entidades participantes será responsable de sus acciones en relación con el incumplimiento de las obligaciones impuestas por el RGPD y el resto de la normativa sobre protección de datos, así como de las obligaciones derivadas del protocolo, el contrato o acuerdo de investigación y sus anexos. |
I.- PARTIES INVOLVED IN DATA PROCESSING
The Hospital acts as the data controller of the patients’ medical records for care purposes. This processing is conducted in application of Article 6.1.c of REGULATION (EU) 2016/679 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27th April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (hereinafter, GDPR or General Data Protection Regulation) and is protected by the provisions of Law 14/1986 of 25th April, General Healthcare Law, Law 41/2002, of 14th November, basic law regulating patient autonomy and the rights and obligations on information and clinical documentation and all other healthcare industry regulations.
b) Data controller of the Study Data
The Sponsor acts as data controller for the data collected for the purpose of the Study, and in particular the coded data thereof, as per the applicable regulation mentioned in the paragraph above.
The Principal Investigator designated by the Hospital is responsible for the practical conduct of the clinical Study.
c) Data processors
For the purpose of the Study, third parties shall act on behalf of each of the Data Controllers and shall be considered as their data processors according to Article 28 of the GDPR and Article 33 of Organic Law 3/2018 of 5th December on the Protection of Personal Data and Guarantee of Digital Rights (hereinafter, the LOPDGDD [Ley Orgánica de Protección de Datos Personales y Garantía de los Derechos Digitales]).
These entities have no access to personal data for their own purposes, but they are processing the data following the instructions of their respective data controllers.
II.- PURPOSE OF THIS ANNEX
This Annex is intended to establish the framework in which the Hospital and the Sponsor, as respective controllers of the data of patients participating in the corresponding clinical Study and in the performance of their own duties, determine the processing of personal data conducted via the collection of clinical information of the Study in compliance with legal requirements.
III.- PURPOSE OF THE DATA PROCESSING
The purpose of the processing of the data regulated through this Annex is the conduct of the clinical Study which shall be conducted pursuant to the GDPR, the LOPDGDD, Regulation (EU) No. 536/2014 of the European Parliament and of the Council, of 16th April 2014, on clinical Studies on medicinal products for human use and implementing legislation, the Protocol and the main clinical Study agreement. In this regard, the participating entities agree that the processing of data shall be performed only for and as a result of the needs of the Study.
The following data processors shall also carry out the processing of the data on behalf of the controllers with the following purposes:
a) CRO/Monitor: Responsible for the direct follow up of the conduct of the Study in accordance with Sponsor’s internal procedures and provisions of article 40 of RD 1090/2015.The monitor acts, in any case, on behalf of the sponsor. b) Foundation: Administrative, legal, economic and technical management, related to the Study. They act on behalf of the Hospital to support the Study.
These entities, as well as any other entities that are designated as data processors, shall be governed by the provisions in their respective contracts which must in any case respect the provisions of this Agreement and of article 28 GDPR. In particular: they shall not engage another processor without prior authorisation of their respective controller and without a written agreement as set forth in article 28.2 and 28.4 of GDPR;
IV.- GUARANTEES PROVIDED BY THE PARTIES
All parties participating in this Study declare that they and their appointed processors offer sufficient guarantees to apply the appropriate technical and organisational measures, so that the processing of data complies with the requirements of the GDPR and other applicable Data Protection laws, and ensures the protection of the data subjects’ rights.
For these purposes, each of the participating entities states that:
They will each keep an up-to-date record of the processing activities. They have designated a Data Protection Officer (“DPO”), whose details are as follows:
a) Hospital Data Protection Officer of the Generalitat Valenciana Xxxxx xx xx Xxxxxxx, 00. 00000 Xxxxxxxx b) Sponsor: Haga clic aquí para escribir texto.
Prior to the processing of Personal Data, the following has been completed: Analysing this data processing according to the principles of data protection from the design and by default, having analysed in particular compliance with the principles regarding processing regulated in Art. 5 of the GDPR and the lawfulness thereof in accordance with Art. 6 of the GDPR. The conduct of a risk analysis and, if necessary, an impact assessment regarding data protection. Applying, based on the risks, appropriate technical and organisational measures to ensure the appropriate level of safety for the risk.
V.- CONDITIONS REGARDING PROCESSING
The entities involved in the Study shall carry out the data processing according to the applicable regulations, codes of good practices, the research Protocol and any others regarding research and the protection of Personal Data.
Each Processor shall immediately inform their respective Controller if, in its opinion, an instruction infringes any applicable data protection regulation.
Without prejudice to article 82, 83 and 84 of GDPR, an if a processor infringes GDPR provisions by determining the purpose and means of processing, this processor shall be considered to be a controller in respect of that processing.
Each of the participating entities is also committed to the processing of the Personal Data according to the following guidelines:
The sponsor is the data Controller of the data pertaining to the Study, and in particular of the coded data of patients participating in it. As part of their duties, they shall carry out the processing under the following conditions:
They shall guarantee that the individuals authorised to process coded personal data, have committed to respecting the confidentiality thereof. The individuals who only need to have access to coded data shall also commit not to perform any activity to re-identify the participants of the Study. Taking into account the state of the art, the application costs and the nature, scope, context and purposes of the processing, as well as the risks of varying likelihood and severity for the rights and freedoms of natural persons, they shall guarantee the application of appropriate technical and organisational measures to ensure an appropriate level of security commensurate to the risk, which may include the following, among others: - encryption of pseudonymised personal data; - the capability to ensure the confidentiality, integrity, availability and permanent resilience of the processing systems and services; - the capability to restore the availability and access to personal data under their control promptly in the event of any physical or technical incident; - a process of regular verification, assessment and evaluation of the efficacy of the technical and organisational measures to guarantee the safety of the processing.
In the event of transferring data internationally, they must provide the guarantees provided for in the GDPR and the LOPDGDD. In the event of any security breach, they shall notify the competent control authority in the manner and within the deadlines set forth in the regulations and they shall communicate it, as applicable, to all other entities involved in the Study. In the event of receiving a request to exercise the data protection rights, they shall act according to the instructions outlined in the section “Exercising the rights of the data subjects”. They shall store the content of the Master File for at least 25 years from the end of the clinical Study. In the event of entering into a contract with a data processor, especially with a monitor (CRO), they shall only be able to choose an entity that offers guarantees of compliance with the GDPR, LOPDGDD and other related regulations and they shall establish the instructions for the data processing carried out by them by signing a contract that complies with the requirements of Article 28 of the GDPR.
Hospital (through Principal Investigator) is responsible for the practical conduct of the Clinical Study, and as such, for the processing of the data under the following conditions:
- They shall provide the data to the sponsor or shall verify that the rest of the investigators do so, in coded form according to the provisions in the research Protocol. - They shall ensure that only those required to do so in order to carry out their duties related to the Study shall have access to Personal Data, and that they and the other investigators have agreed, in writing, to respect the confidentiality of the Personal Data they have access to. - They shall look after and retain the subject identification codes, the informed consent forms granted by the subjects and the data protection information document in accordance with the regulations, protocols or contracts which establish how to conduct them and the timelines for doing so. - They shall apply the technical and organisational measures to ensure compliance with the GDPR and the appropriate level of security for the risk, which in any case must be those established by the National Security Plan. - They shall collaborate with the Sponsor or, if applicable, with the Monitor designated by the Sponsor with regard to the access to data with the sole purpose of carrying out the checks necessary to that the clinical Study is being conducted in compliance with the requirements provided by the applicable laws, regulations, ICH-GCP and the Protocol. - They shall store site’s part of the the content of the Master File for at least 25 years from the end of the clinical Study. - In the event of any security breach or violation, they shall notify the competent control authority in the manner and within the deadlines set forth in the regulations and they shall communicate it to all other entities involved in the Study. - They shall respond to requests of patients to exercise their data protection rights in a timely manner. - In the event that queries are raised with regard to compliance by the Protocol with the data protection regulations, this must be reported immediately to the Sponsor. - In the event of entering into a contract with a data processor, they shall only be able to choose an entity that offers guarantees of compliance with the GDPR, LOPDGDD and other related regulations and they shall establish the instructions for the data processing carried out by them by signing a contract that complies with the requirements of Article 28 of the GDPR.
VI.- DUTY OF COOPERATION
a) In general, the participating entities shall cooperate with each other in the compliance with the GDPR and other applicable regulations, providing to the other entities the information required to facilitate and demonstrate compliance, according to the applicable regulations and the distinct roles of the parties.
b) The Principal Investigator shall cooperate with the Sponsor or entity they delegate (monitor) to perform their duties related to ensuring that the clinical Study is being conducted as required by the applicable regulations and the Protocol, including checking the security measures taken, for which it may carry out as many checks or audits as it is deemed necessary, being able to access identifying personal data for this purpose.
In no case can the Sponsor or Monitor obtain a copy of information or documents containing data that may directly identify the Study subjects.
c) In the event that any of the participating entities suspects a lack of compliance with the personal data protection regulations, within 24 hours of finding out, they shall report this to the other entities and their data protection officers, as applicable depending on the circumstances of the case, who shall determine which parties must be involved in the investigation of the events.
d) The participating entities, with regard to the processing of the clinical Study data, also agree to inform the other entities of:
- The start of any investigation or opening of an inquiry by the data protection control authority. - Any administrative, legal or preparatory process related to the protection of personal data, as well as any decision, order or resolution issued in this regard. - Any incidents affecting the right to data protection of subjects and/or people participating in the Study, including the accidental or unauthorised access, modification, loss, damage, destruction or anything else affecting the personal data.
VII.- EXERCISE OF THE RIGHTS OF THE DATA SUBJECTS
The exercise of the rights regulated by the data protection regulations and the withdrawal of consent to the processing of the data shall be exercised with the Principal Investigator who is obliged to inform the corresponding Data Controller (if necessary in pseudonymised form) to resolve it promptly and in the manner established by law.
In the event that a subject participating in the clinical Study exercises its rights through an entity or person other than the Principal Investigator, this entity or person shall instruct the patient to contact the Principal Investigator of the Study.
VIII.- REPORTING SECURITY BREACHES
It shall be the respective data controllers, sponsor and hospital who must fulfil the reporting duty in cases where there is a personal data security breach or violation, when circumstances requiring it to be reported to the control authority are met.
IX.- INTERNATIONAL TRANSFERS
In the event that the clinical Study requires international transfers of data to countries outside of the European Economic Area, the legal regimen established for such transfers in the GDPR and LOPDGDD shall be complied with and guarantees shall be provided in that regard. For this purpose, it is understood that there are guarantees for making international transfers when: a) They are made to a country, territory, specific industry or international organisation that has been declared to have an adequate level of protection by the European Commission. b) They are made between companies of the same group and binding corporate standards have been approved according to Art. 47 of the GDPR. In this case, these standards or the web address where they can be accessed shall be attached as an appendix. c) The data protection standard contractual clauses adopted by the Commission or adopted by a control authority and approved by the Commission have been signed. A copy of the signed clauses shall be attached as an annex. d) The entities carrying out the transfer of data adhere to a code of conduct or mechanism of certification, along with binding commitments enforceable by the data controller or processor in the third country to apply adequate guarantees, including those regarding the rights of the data subjects. A copy of the code of conduct or certification or website where it can be accessed shall be provided as an annex.
In all other cases, international transfers of data are prohibited unless authorised by the competent control authority.
X.- INFORMATION TO THE SIGNATORIES AND RESEARCH TEAM
The personal data provided for the signing of the present Agreement (“Contractual Data”) and the management of the clinical Study shall be processed in accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27th April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (GDPR) and Organic Law 3/2018 of 5th December on the Protection of Personal Data and Guarantee of Digital Rights (LOPDGDD).
Investigator and Study Personnel’s data shall be processed by Xxxxxxx as stated in “Privacy notice for the clinical study research team” , which was provided (or will be) to Hospital/Principal Investigator and all current and future Principal Investigators, sub-investigators, and research staff.
The Contractual Data shall be processed based on the following conditions:
Data controllers: Hospital. Sponsor Purpose: Management of the clinical Study contracts. Legal basis: On the part of the Hospital: ▪ Article 6.1.b) GDPR: processing is necessary for the performance of a contract to which the data subject is party. .▪ Article 6.1.e) GDPR: processing is necessary for the performance of a task carried out in the public interest or in the exercise of public powers granted to the controller; On the part of the sponsor: ▪ Article 6.1.b) GDPR: processing is necessary for the performance of a contract to which the data subject is party. ▪ Article 6.1.f) GDPR: the processing is necessary to satisfy the legitimate interests pursued by the data controller.
The foregoing, in relation to the provisions in Royal Decree 1090/2015, of 4th December, regulating clinical drug Studys, Drug Research Ethics Committees and the Spanish Clinical Studys Registry.
Storage period: The data shall be kept for the time required to fulfil the purposes for which it was collected and to determine the possible responsibilities that may result from this purpose and the processing of the data. The provisions in the regulations on filing and documentation for clinical Studys shall apply.
Categories of personal data: First name and surnames, DNI (Documento Nacional de Identidad [National Identity Card])/NIF (Número de Identificación Fiscal [Tax Identification Number])/Identification document, address, signature and telephone number. Data on employment details: position held and qualification of staff and, if applicable, documents on national insurance contributions.
Category of recipients: Agencia Española de Medicamentos y Productos Sanitarios - AEMPS.
Security measures: The security measures implemented are consistent with those contained in Annex II (Security Measures) of Royal Decree 3/2010 of 8th January, which regulates the National Security Scheme in the area of Electronic Administration.
Exercise of the rights: The data subjects of this processing have the right to request access to their personal data, the rectification or deletion thereof, the limitation of processing or to oppose it, in writing, with proof of identification, addressed to the data controller.
You can access the procedure guide at the following web address: Procedure guide: xxxxx://xxx.xxx.xx/xx/xxxxxx/xxxxxxxxxxxxxx?xx_xxxxx00000&xxxxxxxxxxx
Contact details of the Data Protection Officer of the Generalitat Xx. Xx xx Xxxxxxx, 00. 00000 Xxxxxxxx Email Address: xxx@xxx.xx
Complaint to the Agencia Española de Protección de Datos: If the data subjects believe that they have been adversely affected by the processing or in exercising their rights, they can file a complaint with the Agencia Española de Protección de Datos at the website xxxxx://xxx.xxxx.xx/
XI.- RESPONSIBILITY
Each of the participating entities shall be responsible for their actions with regard to the failure to comply with the obligations provided by the GDPR and the other data protection regulations, as well as the obligations arising from the protocol, the contract or study agreement and its annexes. |
Documento 3 Acuerdo de procesamiento de muestras Biobanco INCLIVA
Document 3 Sample Processing Agreement - Biobank INCLIVA
El presente Acuerdo tiene como fin establecer los términos y condiciones en virtud de los cuales el BIOBANCO INCLIVA realizará el procesamiento y conservación de muestras biológicas asociadas al Haga clic o pulse aquí para escribir texto. (en adelante las Muestras) bajo la dirección del Dr./Dra. Haga clic o pulse aquí para escribir texto.
Tendrán consideración de Muestras, las muestras biológicas (Haga clic o pulse aquí para escribir texto.) obtenidas directamente de las participantes en el Haga clic o pulse aquí para escribir texto. y los productos derivados de las mismas.
Estas muestras se procesarán siguiendo el manual de laboratorio del promotor del ensayo.
Además, el Biobanco se encargará de cumplimentar el documento de trazabilidad aportado por el promotor.
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The purpose of this Agreement is to establish the terms and conditions under which, BIOBANCO INCLIVA, will carry out the processing and conservation of biological samples associated with the Haga clic o pulse aquí para escribir texto. (hereinafter the Samples) under the direction of Dr. Haga clic o pulse aquí para escribir texto.
Biological samples (Haga clic o pulse aquí para escribir texto.), obtained directly from the participants in the Haga clic o pulse aquí para escribir texto., and the products derived from them will be considered Samples.
These samples will be processed following the laboratory manual of the trial sponsor.
In addition, the Biobank will be responsible for completing the traceability document provided by the sponsor. |
Se adjunta a continuación, el presupuesto estimativo:
The estimated budget is attached below:
Haga clic o pulse aquí para escribir texto.
Se facturarán los servicios efectivamente realizados desde la formalización de la prestación del servicio hasta el momento de la facturación, con una periodicidad semestral.
Se contactará con la responsable del Biobanco INCLIVA, Dra. Xxxxxx Xxxxx, (xxxxxxxx@xxxxxxx.xx) para la facturación de los servicios prestados por el Biobanco.
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The performed services will be invoiced from the formalization of the provision of the service until the moment of invoicing, with a biannual periodicity.
For the invoced of the provided services, it should be contacted with Xx. Xxxxxx Xxxxx (xxxxxxxx@xxxxxxx.xx), person in charge of the Biobank INCLIVA. |
Y en prueba de conformidad, las partes suscriben el presente contrato de ensayo clínico, sus anexos y el acuerdo relativo al tratamiento de datos, mediante firma electrónica y a un sólo efecto. |
And in proof of conformity, the parties sign this clinical trial contract, its annexes and the agreement regarding data processing, by electronic signature and for a single effect. |
Por Hospital / By Hospital Hospital Clínico Universitario de Valencia |
Por la Fundación / By Foudantion Fundación de Investigación del Hospital Clínico Universitario de Valencia |
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Name/Nombre: Xx. Xxxx Xxxxxx Xxxxx Xxx |
Name/Nombre: X. Xxxxxxx de Xxxx Xxxxxx |
Title/Titulo: Director Gerente / Site Manager |
Title/Titulo: Director Gerente / Managing Director |
Por el Promotor / By Sponsor |
Por el Investigador / By Investigator |
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Name/Nombre: Haga clic o pulse aquí para escribir texto. |
Name/Nombre: Haga clic o pulse aquí para escribir texto. |
Title/Titulo: Haga clic o pulse aquí para escribir texto. |
Title/Titulo: Haga clic o pulse aquí para escribir texto. |
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