CONTRATO DE ENSAYO CLÍNICO

Transcription

1 CONTRATO DE ENSAYO CLÍNICO Protocol No.: Title: EUDRACT no.: Clinical Research Ethics Committee (CEIC) approval Fundació St Joan de Déu (FSJD) Code No... date Reference CEIC Report:. dated: Authorisation from the Spanish Agency for Health and Medicinal Products (AEMPS):. Esplugues de Llobregat, (date) On the one hand, PARTIES HOSPITAL SANT JOAN DE DEU, with address at Pg. Sant Joan de Déu, 2, Esplugues de Llobregat, and Corporate Taxpayer s Code (CIF) No. R C (hereinafter, the HOSPITAL ), represented herein by its Managing Director Mr Manuel del Castillo Rey. The HOSPITAL is a non-profit entity whose activities turn around maternal and child services. It is classified as a high complexity hospital, and its aims include research and dissemination activities relating to the area of health. FUNDACIÓ SANT JOAN DE DEU, with address at Calle Santa Rosa, 39-57, 3rd floor, Edificio Docente, Esplugues de Llobregat (Spain), and Corporate Taxpayer s Code (CIF) No. G (hereinafter, the FOUNDATION ), represented herein by its Director Mr. Emili Bargalló Angerri. The FOUNDATION is a non-profit entity created with the founding goals contained in Article 3 of its By-laws, and one of its aims is to promote research in the healthcare and/or social areas of the centers belonging to the Hospital Order of St. John of God and other institutions which may be interested Dr.., the holder of Tax Identification Number (NIF), in his capacity as Principal Investigator of the Clinical Trial to which this contract relates; hereinafter, the INVESTIGATOR. And, on the other,., with registered address at., and Corporate Taxpayer s Code (CIF) No..., represented by its..l, hereinafter, the SPONSOR.

2 The appearing parties acknowledge each other s full capacity to enter into contracts and be bound. WHEREAS I. The OBJECT of this agreement is to regulate the terms under which the trial referred to in the heading is to be carried out. The Trial shall be conducted in accordance with the Project Protocol which, in spite of not being attached to this contract, forms an integral part hereof, to the extent that all parties are acquainted with it and agree to it. The said Protocol is filed with the FOUNDATION S CEIC. II. The PRODUCT(S) to be trialled is/are: III. The SPONSOR wishes to conduct the Clinical Trial, under the management of the appearing INVESTIGATOR, who has been chosen by the SPONSOR without any intervention or involvement from the HOSPITAL or the FOUNDATION. The SPONSOR declares that it is familiar with, and accepts, the INVESTIGATOR s commitment and responsibility in connection with the conduct of the Clinical Trial in the terms of Articles 35, 37 and 43 of Spanish Royal Decree 223/2004 of 6 February IV. The appearing INVESTIGATOR accepts the management of the Clinical Trial in accordance with the terms of its Protocol and the provisions of Articles 8.3, 37 and 42 of Spanish Royal Decree 223/2004 of 6 February In addition, the INVESTIGATOR is responsible for selecting the members of the research team and support personnel for the Trial, which may be comprised of both natural persons and commercial or other entities with the necessary human and material resources to carry it out. V. The FOUNDATIONS s CEIC (Clinical Research Ethics Committee) has approved the content of the Trial reflected in the Protocol provided by the SPONSOR in the specific terms of the said Protocol and on the date stated in the above mentioned heading hereof. For the purposes of this agreement, the content of the Protocol shall also be deemed to include any amendments thereto which may be formally approved by the FOUNDATIONS s CEIC from this date. VI. The SPONSOR undertakes to refrain from under any circumstances commencing the trial until the mandatory authorisation from the Spanish Agency for Health and Medicinal Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) has been issued.

3 VII. The Trial affects. completed SUBJECTS and has an expected DURATION of months in the form and under the terms contained in the Protocol which describes it. The subjects who decide to take part in the Trial shall receive all information which may be necessary to know, without qualification, the details and characteristics of the study, including any effects it may have and its intended benefit; they shall not submit to it without their express signed authorisation, in accordance with the terms of Chapter II of Spanish Royal Decree 223/2004. VIII. Once the trial has begun, any MODIFICATION to the Protocol of the Trial to which this agreement relates, regardless of its nature, must be expressly approved by the FOUNDATION S CEIC. If it results in changes affecting any clause of this agreement, an ADDENDUM must be drawn up and attached hereto. IX. The FOUNDATION is responsible for the financial management of this Trial, receiving the SPONSOR s payments and distributing them as provided in Annex I. In view of the foregoing, the appearing parties agree to enter into this agreement, which shall be governed by the following: 1. Applicable Legislation CLAUSES The Trial shall be carried out strictly in accordance with the rules applicable to the treatment of trials both applicable internationally and issued by the Spanish central and Catalonian (Generalitat de Catalunya) governments, and especially with Royal Decree 223/2004 of 6 February 2004 regulating clinical trials with drugs. The Guidelines for Good Clinical Practice (CPMP/ICH/135/95) published by the Spanish Ministry of Health and Consumption (Ministerio de Sanidad y Consumo) shall mandatorily be referred to in the conduct of the Trial. In addition, the trial shall be subject to the ethics criteria contained in the professional Code of Ethics and rules of this nature which may be issued by the CEIC which validates the trial and, in any event, to the indications which may be issued by the FOUNDATION s CEIC. 2. Drugs under Investigation The SPONSOR shall supply, free of charge, the drugs, medical supplies, apparatus, devices and any other elements whose use is not contemplated in habitual clinical practice, and shall be responsible for the costs of analyses or other types of diagnostic tests not envisaged for the treatment of the ailment but necessary to achieve the goals of the Trial.

4 The drugs shall be delivered to the centre s pharmacy department, which shall be responsible for their distribution, preservation and dispensing in accordance with the provisions of the protocol, and which shall be privy to the type of coding and unblinding. On completion of the Trial, the Pharmacy Department shall return to the sponsor any samples not used in the trial. In addition, the SPONSOR shall ensure that the products for conducting the trial are manufactured and/or prepared in accordance with Good Manufacturing Practices and labelled in accordance with the current legislation. 3. Insurance for the Trial With regard to any liability which may arise, either vis-à-vis third parties or vis-àvis the FOUNDATION, the HOSPITAL, the INVESTIGATOR and his/her collaborators, and the subjects of the Clinical Trial, the SPONSOR has taken out a Civil Liability insurance policy with at least the cover specified in Article 8 of Royal Decree 223/2004 of 6 February 2006 and shall be up to date with the premium payments. The details of the policy taken out are: Insurer: Policy no.:. If this is insufficient to cover the damages, the SPONSOR shall be jointly and severally liable with the INVESTIGATOR, the FOUNDATION and the HOSPITAL with any other contracted policies which may have been taken out. 4. Suspension of the Trial The conduct of the Clinical Trial may be cancelled on one party s request or by mutual agreement, in the following circumstances: a) On any of the grounds set out in Article 26 of Royal Decree 223/2004 of 6 February b) If it is not possible to include a minimum number of subjects to enable the final assessment of the Clinical Trial to be carried out in a reasonable time according to the characteristics of the Clinical Trial. c) If an interim analysis of the data leads to the conclusion that continuing to administer the medication under study to the Clinical Trial subjects is either unsafe or unwarranted. d) Breach of either party s obligations assumed hereunder. e) Mutual agreement of the parties. f) At the instance of one of the parties, following at least one month s written notice. In any of these cases a report stating the reasons for the suspension of the trial shall be drawn up and signed by both parties.

5 The SPONSOR shall, within a maximum of three (3) months following the completion of the Trial at the HOSPITAL, inform the FOUNDATION, in writing, of the total number of: 1) Subjects who have been recruited and assessed; 2) Visits actually carried out; 3) Incidents; 4) Any extraordinary test, analysis, exploration, consultation or hospital stay regardless of whether or not such event is stated in the Financial Report (Annex 1). In the event of early termination of the clinical trial, the sponsor shall be under an obligation to pay for all services carried out in connection with the trial until the date of termination. The termination of the clinical study in progress shall require the parties to hold discussions and coordinate with each other to guarantee the safety of subjects, the continuity of treatment and compliance with the current applicable legislation. 5. Financial Aspects In return for conducting a clinical trial, the sponsor will pay, the amount of plus VAT applicable, for evaluable patients, for the same budget and whose details are set out in the financial report, Annex 1, attached hereto. Payments must be made upon presentation of invoice by the FOUNDATION, to which VAT will be applied in accordance with applicable law at the date of issuance of the same name as the SPONSOR. Payment will be made by bank transfer, the costs borne by the originator, to: Fundació Sant Joan de Déu Banking Institution: La Caixa Account No.: IBAN: ES SWIFT: CAIXESBBXXX The SPONSOR shall pay the invoice, within 30 days of the date thereof. For subjects who were included but did not complete the study, the amount to be paid shall be calculated pro rata to the number of visits and tests carried out until that date. The SPONSOR hereby states for the record that no agreements relating to the conduct of this study at the HOSPITAL, resulting in additional financial remuneration or other types of consideration, have been or will be concluded outside this contract with the INVESTIGATOR or with collaborating investigators of the FOUNDATION or the HOSPITAL. This clause does not apply to expenses relating to Trial organisation meetings if the study includes multiple centres, or to any facilities which may in future be arranged by the SPONSOR for the dissemination of the results of the Trial in scientific publications and meetings.

6 Once the contract is signed, the FOUNDATION will send and invoice to the SPONSOR, for the amount of 400 as fees for contract management. This fee will be invoiced to: PROMOTOR name: Direction: VAT number: And will be sent to: 6. Confidentiality and Personal Data Protection The investigator and the hospital is committed to ensuring that all documentation, information, results and data related to the study are treated in accordance with its confidentiality and secrecy, ensuring the restricted circulation of such information and taking responsibility for this obligation to be fulfilled for all staff having access to it. The SPONSOR warrants that the Trial protocol establishes the necessary mechanisms to break any association between the personal data contained in the centre s patient file and the subjects taking part in the trial. Access to the trial subjects' clinical documentation shall be in accordance with the provisions of Law 41/2002 of 14 November 2002 (the basic law regulating patients autonomy and rights and obligations regarding clinical documentation and information) and its developing legislation. The Parties warrant that the study subjects' personal data shall be treated in accordance with the provisions of the Spanish Data Protection Law (Ley 15/1999 de protección de datos de carácter personal) and developing regulations; the subjects included in the study shall remain anonymous and their identities shall be protected; and no personal data relating to the study subjects shall be released to third persons not involved therein except where permitted by law. This confidentiality undertaking shall not apply to information which: (i) is in the public domain; (ii) was already known to the PRINCIPAL INVESTIGATOR or the FOUNDATION when it was disclosed; or (iii) had to be disclosed pursuant to a legal requirement. If any Party is required by a governmental or court entity to disclose part of the confidential data provided, the said Party must notify the other party sufficiently in advance to enable it to take any steps, and put in place any procedures, which may be necessary to protect itself against the consequences of releasing such information. The HOSPITAL shall allow inspectors from the competent healthcare authorities to access these data. At the end of the contractual performance, the SPONSOR shall destroy or return all personal data to which it may have had access, as well as any media on which they may be recorded, pursuant to Article 12.3 of the Spanish Data Protection Law (Ley Orgánica de Protección de Datos de Carácter Personal).

7 7. Intellectual Property The INVESTIGATOR undertakes to furnish the SPONSOR with the full results of the tests and all data obtained during the Trial. The results of the Trial, discoveries, inventions and methods, as well as all work and reports carried out and the industrial property rights arising there from belong to the SPONSOR, which may therefore fully and freely dispose of them, and the Parties shall be subject to the applicable legal provisions. This is without prejudice to the rights granted by law to investigators to use the results in their professional activities. In the event that ownership of aspects resulting from the trial is registered or recorded, the HOSPITAL and the INVESTIGATOR shall facilitate any procedural steps which may be necessary to that end, without prejudice to any share of profit which may be established. The SPONSOR reserves the right to use the results of this Trial to submit them to the health authorities of any country. 8. Publications In accordance with Royal Decree 223/2004, the SPONSOR undertakes to publish the results obtained, regardless of whether they are positive or negative, once the TRIAL has been completed. Such publication shall take place in publicly accessible scientific media. Sponsor may make study results public by posting a summary of the results in Sponsor s online Clinical Trial Register before or after publication by another method. The publication of results in scientific books or journals by the INVESTIGATOR shall be carried out with the SPONSOR s agreement; the SPONSOR must be given a copy of the manuscript or original to enable it to see its contents and carry out any appropriate verifications. The SPONSOR must tell the INVESTIGATOR whether or not it agrees with its content within a maximum of 30 days. If no written reply from the SPONSOR is received within this time, it shall be deemed to have agreed, and the INVESTIGATOR may publish the content. In the case of posters, abstracts or other limited texts, the deadline shall be 15 days. In the event of a trial involving multiple centres, no publication shall be permitted until the final results of the study have been published. The SPONSOR shall request express authorisation from the FOUNDATION, the HOSPITAL and the principal INVESTIGATOR to use their names in scientific publications or any other media for commercial or dissemination purposes. 9. Arbitration

8 The parties agree to comply and continue this contract in the spirit that has made possible a commitment to resolving disputes that may arise in terms of equity. All disputes that may arise concerning the interpretation and enforcement of this contract shall be submitted to the Courts and Tribunals of Esplugues de Llobregat (home of the FOUNDATION and the HOSPITAL), whose jurisdiction expressly submit all signatories expressly waive their own jurisdiction if different. If this Contract is also signed in another language, the interpretation of Spanish version shall prevail. For the proper record of all agreed and proof of compliance, the Parties have signed this document in quadruplicate, and a single effect in the city and date specified at the beginning. THE HOSPITAL THE SPONSOR Mr Manuel del Castillo Rey Managing Director Mr THE FOUNDATION THE INVESTIGATOR Mr Emili Bargalló Angerri Director Dr..