Protocol Code
CONTRACT TO PERFORM THE CLINICAL TRIAL ENTITLED “____name____”
Protocol code:
Foundation code:
In Majadahonda, ______20YY.
BY AND BETWEEN
The party of the first part, Mr/Mrs/Ms. ______(name of the SPONSOR’S legal representative), with National Identity Document nº ______acting in the name and in representation of ______(the PROMOTING entity’s full address - pharmaceutical laboratory, scientific society, legal entity), (hereinafter, the “SPONSOR”), with headquartersin ______(the SPONSOR’S full address) in ______(town/city and post code)with Tax ID nº ______and duly authorized to that effect, in accordance with the powers of attorney issued in ______, dated ______, before the notary Mr/Mrs/Ms. ______.
Party of the second part, Mrs. María Codesido López, with Tax ID nº 33.236.014-W, acting in the name and in representation of “FUNDACIÓN PARA LA INVESTIGACIÓN BIOMÉDICA DEL HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA”, (hereinafter, the “FOUNDATION”)and in the capacity of President of the same, with headquarters in Majadahonda - Madrid (28222), calle Joaquín Rodrigo, 2, and Company Registration Number (C.I.F.)G83726968.
Mrs. María Codesido Lópezalso acts in the name and in representation of the “Hospital Universitario Puerta de Hierro Majadahonda” (hereinafter, “THE HOSPITAL”), by virtue of and in conformity with the agreements between the FOUNDATION and the HOSPITAL.
And party of the second part, Dr. ______(the PRINCIPAL INVESTIGATOR’S name),withNational Identity Document nº ______, acting in their own name and in their own right (hereinafter, the “PRINCIPAL INVESTIGATOR”), with address for the purpose of notifications in the ______Service of the HOSPITALsituated in calle Joaquín Rodrigo nº 2, 28222 Majadahonda(Madrid), withCompany Registration Number (C.I.F.) Q-2877005-E.
The Parties declare to be of legal age and to have sufficient legal capacity to be bound to the terms and conditions of the present Contract (hereinafter, the Parties).
DO HEREBY STATE
That the SPONSORis interested in carrying out the CLINICAL TRIAL described in the first clause of this contract.
That in agreement with that determined in the current agreement signed between IMSALUD and the FOUNDATION on 17th June 2009, the management of all Clinical Trials carried out in the Puerta de Hierro University Hospital corresponds, among other functions, to the FOUNDATION. The agreement signed between the Puerta de Hierro Hospital and the FOUNDATION on 24th February 2005 similarly ratifies that those Clinical Trials which are carried out within the installations of the Puerta de Hierro Hospital must be contracted and implemented by the FOUNDATION.
On the basis of the above, the Parties have determined to formalize the present Contract in accordance with the following:
CLAUSES
FIRST.-OBJECT
1.1.The object of the present Contract is the performance of the TRIAL entitled “______” (hereinafter, the TRIAL) protocol code “______”(hereinafter, the PROTOCOL), which shall be fundamentally carried out within the dependencies of the HOSPITAL identified in the Description of this Contract, under the management and responsibility of Dr. ______who shall act as PRINCIPAL INVESTIGATOR of the same. The TRIALshall be carried out in agreement with the content specified in the PROTOCOL, of original version ______and date ______, notified to the Clinical Research Ethics Committee (hereinafter, the CEIC) of the Puerta de Hierro University Hospital, Majadahonda, and with a Favourable Decision from the Reference CREC (reference CREC data) (Annex III).
SECOND.-COMMENCEMENT AND DURATION
2.1.- Under no circumstancesshallTHE TRIALcommence until the mandatory authorization been granted by the Spanish Drug and Health Product Agency (Agencia Española de Medicamentos y Productos Sanitarios)(hereinafter, AEMPS), the corresponding Clinical Research Ethics Committee, the Consent of the HOSPITAL Management (Annex IV), and any other authorization which, where appropriate, is required by applicable legislation or regulations. The parties shall commit themselves to safeguard that the TRIAL is carried out in accordance with that specified in the PROTOCOL and, especially, that the TRIAL is not commenced without prior authorization from the AEMPS.
2.2.- The TRIAL is predicted to last a total of ______months, a period which shall be counted from the time that authorization is obtained from the AEMPS in accordance with the terms indicated in the PROTOCOL. In the event of competitive recruitment, the number of subjects recruited may vary with respect to the initial forecast.
THIRD.-APPLICABLE REGULATIONS
3.1.The Parties shall undertake, at all times, to respect and comply with all current legislation which is applicable to the signing of this Contract and throughout its term, as well as to expressly adhere to the principles and ethical standards, and of particular importance, the following:
3.1.1.Act 29/2006, dated 26th July, Guarantees and Rational Use of Drugs and Healthcare Products.
3.1.2.Royal Decree 223/2004, dated 6th February, which regulates clinical drug trials (hereinafter, RD 223/2004).
3.1.3.Decree 39/1994, dated 28th April, which regulates the responsibilities in relation to clinical drug trials within the Community of Madrid.
3.1.4.Order SCO/393/2006, dated 8th February, and Order SCO/326/2008, dated 4th February, which modify the above laying down the principles and detailed directives for good clinical practice and the requirements to authorise the manufacture or importation of drugs for clinical trials in humans.
3.1.5.The Helsinki Declaration in its latest version issued in October 2008.
3.2.The Parties shall ensure compliance with the regulation regarding incompatible activities corresponding to staff employed in the Public Administration, pursuant to Act 53/1984, dated 26th December and Royal Decree 598/1985, dated 30thApril
FOURTH.-OBLIGATIONS OF THE PARTIES
4.1.The Parties shall bebound to fully implement the provisions provided for in this Contractin accordance with the terms of the same and the PROTOCOL. Each Party shall perform its specific obligationsin compliance and in accordance with the regulations stated in the Third Clause. The obligations, duties and functions stipulated in RD 223/2004 establish, to all intents and purposes, obligatory content in this contract in such a way that failure to comply with the same shall be considereda breach of the same.
4.2.The obligations of the Parties:
4.2.1.To collaborate in the TRIAL monitorial visits that are carried out by: (i) the CREC, (ii) monitors and auditors acting on behalf of the SPONSOR, and (iii) competent authorities when carrying out inspections. Notification of these visits must be given at least one week prior to the same except where other periods are agreed between the Parties. During these follow-up, monitorial and audit visits, the necessary technical and organisation measures must be taken to guarantee the maximum respect for the regulations concerning personal data protection.
4.2.2.The INVESTIGATOR, the SPONSOR, the monitors and auditors will observe the rules of internal procedure established by the HOSPITAL and the FOUNDATION, as well as any indications regarding the development of the TRIAL that are given by the CREC responsible for its follow-up.
4.2.3.Not make,in relation to carrying out the TRIAL, any agreements or other terms or exceptions to this Contract or which contravene the same. To this effect, each individual Party shall declare that, on the date of this Contract, they do not form part of any agreement or contract which may contravene the same. In particular, by virtue of this Clause the Parties accept that they shall not agree to nor pay the PRINCIPAL INVESTIGATOR, nor any of their collaborators, compensation of any type other than those stipulated in this Contract. The expenses for any meetings held with the aim of organizing or supervising the TRIAL are excluded from this prohibition, as well as those aimed at analyzing or making known the results of the same (scientific presentations or publications).
4.3.In addition to that set out in the applicable legislation, the SPONSORshall also be under the obligation to give the PRINCIPAL INVESTIGATOR continuous support and provide the same and the CREC with any new, relevant information which arises in relation to the drug undergoing investigation.
4.4.The FOUNDATION shall be under the obligation to manage all the financial matters related to the current TRIAL, to receive the payments made by the SPONSOR and distribute the same in accordance with that stipulated in Annex I.
4.5.The PRINCIPAL INVESTIGATOR shall undertake to safeguard the identification codes related to the participating patients. The SPONSOR and the PRINCIPAL INVESTIGATOR shall undertake to retain the essential documents related to the TRIAL for the time and under the conditions established by current legislation.
4.6.It shall also be incumbent on the PRINCIPAL INVESTIGATOR to select the members of the TRIAL investigating team and support personnel, which may be comprised of individuals or business entities or of any other nature, which have the material and personal resources required to carry out the same.
FIFTH.-FINANCIAL ASPECTS
5.1.The initial estimated cost of this TRIAL amounts to ______EUROS (______€) (hereinafter, the Trial Budget). This amount has been calculated through the application of the cost of ______EUROS (______€) per evaluable subject, in accordance with that established in the Financial Report of the TRIAL (Annex I) in which all the financial aspects of the same are specified.
5.2.The amount to be paidby the SPONSOR during the period of the TRIAL shall be determined through the application of Annex I and shall be paid to the FOUNDATION in accordance with the following terms:
5.2.1.0% of the TRIAL Budget shall be paid at the moment that this Contract is signed.
5.2.2.The TRIAL Budget shall be paid, at a minimum, half-yearly in accordance with that specified in the table of amounts per visit and recruited patients included in Annex I, until the full payment of the amount which constitutes the said Budget. To this effect, the SPONSOR and the PRINCIPAL INVESTIGATOR shall keep the FOUNDATION informed on a quarterly basis.
5.2.3.These payments shall be deemed payments on account, subject to the settlement of the final amount of the TRIAL.
5.3.The final amount payable by the SPONSOR or carrying out the TRIAL shall be determined according to the activity effectively carried out during the period of the TRIAL (hereinafter, the Final Amount). The Final Amount shall be calculated as follows:
5.3.1.In a maximum period of three (3) months from the termination of the TRIAL in the HOSPITAL, the SPONSOR and the PRINCIPAL INVESTIGATOR shall notify the FOUNDATION in writing of: (i) the subjects recruited and evaluated, (ii) thevisits actually made, (iii) the incidents that occurred, as well as (iv) any extraordinary test, analysis, examination, consultation or hospital admittance that occurred whether or not reflected in the Financial Report (Annex I).
5.3.2.As soon as possible after the submission of the information referred to in the previous paragraph, the FOUNDATION shall calculate the Final Amount for the TRIAL and notify the Parties involved and, where applicable, any amounts pending payment by any of the same. This Final Amount settlement shall determine the amounts due for each Party and shall be paid by the resulting creditors within a period of one (1) month without any further correspondence being required.
5.4.All payments shall be based on the submission of an invoice to which VAT will be applied in accordance with the legislation in effect on the date of issue of the same, and in the name of the SPONSOR. Payments shall be made by bank transfers, with all charges to be borne by the originator, to:
Name.“Fundación para la Investigación Biomédica del Hospital Universitario Puerta de HierroMajadahonda”
Bank.“BANCO DE SANTANDER”
Account number.0049 1976 32 2610000382
IBAN CODE. ES0400491976322610000382
SWIFT.BSCHESMMXXX
Invoicesshall be issued in the name of: (include name, address and fiscal identification number)
And shall be sent to: (include postal address and contact department/person).
5.5.Payments made by the SPONSOR to the FOUNDATION shall be totally final for the former, the FOUNDATION shall be responsible for the payment of the amounts, where applicable, that correspond to the Investigators or subjects involved in the TRIAL.
SIXTH.-INSURANCE AND RESPONSIBILITIES
6.1.The SPONSORshall hold a Civil Responsibility Insurance Policy which complies in all aspects with that established in RD 223/2004. The said policy, number ______, which has been drawn up with the ______insurance company, covers the damages that could arise to subjects through their participation in the TRIAL covered by this Contract; the SPONSORshall maintain the validity of the said policy through the payment of all due premiums. Within its scope of cover, the said policy shall also include, and specify, the PRINCIPAL INVESTIGATOR and their collaborators, the HOSPITAL and the FOUNDATION (a copy of the policy or certificate of the same is attached as Annex II).
SEVENTH.-CONFIDENTIALITY AND PERSONAL DATA PROTECTION GUARANTEES
7.1.With respect to Personal Data Protection, this Contract shall be governed by the clauses contained within the same or, in their absence, according to the provisions of Organic Law 15/1999, dated 13th December, of Personal Data Protection (hereinafter, the LOPD), the RD 1720/2007, dated 21st December, which approved the Regulation for the development of the Act (hereinafter, the RDLOPD), its complementary legislation.
7.2.All the Parties, insofar as they access and manage personal data related to the subjects included in the TRIAL, shall take opportune measures to protect and avoid access to the same by any unauthorized third party. The Parties shall strictly observe the terms established by the Organic Personal Data Protection Act 15/1999, dated 13th December, and its development Regulation RD 1720/2007, Act 8/2001, dated 13th July, of Personal Data Protection in the Community of Madrid, and Act 41/2002, dated 12th November, basic regulator of the freedom of the patient.
7.3.The Parties shall undertake to use all measures at their disposal to guarantee the confidentiality of the information supplied to carry out the TRIAL and that obtained during the performance of the same, as well as the personal data related to the subjects recruited for the same, with the aim of complying with all the requisites established by current legislation. The following shall remain excluded from this commitment to confidentiality, any information which: (i) is in the public domain, (ii) was previously known to the PRINCIPAL INVESTIGATOR or the FOUNDATION at the time of its disclosure, or (iii) was divulged due to legal requirements.
7.4.In accordance with the definitions established by the RDLOPD:
7.4.1.The HOSPITALshallbe responsible for the personal data files used during TRIAL.
7.4.2.The FOUNDATION, by virtue of its objective and the services provided by the HOSPITAL, shall require access and management of personal data files belonging to the HOSPITAL for research purposes within the conditions laid down by current legislation, and shall therefore be responsible for their management.
7.4.3.The SPONSORand the PRINCIPAL INVESTIGATOR shall require access to personal date belonging to the HOSPITAL, and accessed and managed by the FOUNDATION, which corresponds exclusively to the subjects recruited for the TRIAL. For these data, provided by the FOUNDATION, both the SPONSOR and the PRINCIPAL INVESTIGATOR shall be considered jointly responsible for their management.
7.5.The access and subsequent management of the data belonging to the HOSPITAL and processed by the FOUNDATION on behalf of those responsible for the processing to carry out the TRIAL which is the subject matter of this contract, shall under no circumstances be considered a surrender of data between the said entities and those responsible for its processing.
7.6.In accordance with that established, with respect to responsibility for the processing of personal data corresponding to the subjects recruited for the TRIAL, both the SPONSOR and the PRINCIPAL INVESTIGATOR shall undertake:
7.6.1.To process the data files in accordance with the instructions issued by the HOSPITAL or the FOUNDATION through both verbal and written negotiations, agreements, contracts and pre-contracts.
7.6.2.Not to use such data files for purposes other than to carry out the TRIAL, nor to disclose the same, even for safekeeping, to third parties except in cases where it is necessary to subcontract any of the services covered by this contract which those responsible for their processing render to the FOUNDATION.
7.6.3.To takeall the technical and organizational measures which, pursuant to Article 9 of the LOPD and RDLOPD, ensure the security of personal data and avoid their alteration, loss, unauthorized access or processing, in accordance with security levels applicable to the processing of personal data corresponding to the subjects recruited for the TRIAL (HIGH level).
7.6.4.To maintain,pursuant to Article 10 of the LOPD, the due professional secrecy with respect to the personal data which is processed for the purpose of performing this Contract, both during the TRIAL and after its termination, undertaking to use the data files solely for the agreed purpose and to demand the same level of commitment from any collaborator who participates in any phase of personal data treatment within their organization.
7.6.5.After the completion of the TRIAL,to destroy or return all personal data to the FOUNDATION in accordance with its instructions, together with any support or documentation that contains any personal data related to the treatment.
7.6.6.That the HOSPITAL, being responsible for the data files, or the FOUNDATION, being responsible for processing the same, may audit the SPONSOR and the PRINCIPAL INVESTIGATOR, being the bodies responsible for processing the TRIAL data, with the aim of checking compliance with this Contract and especially with respect to the technical and organizational security measures that these are bound to comply with.
7.6.7.That should those responsible for processing the data use the data for other purposes, disclose or use the same in breach of the stipulations of thisContract, they shall also be considered responsible for the processing, shall personally answer for the breaches incurred, meet any liabilities arising from their failure to comply with the legislation and regulations, indemnify and hold harmless the HOSPITAL and the FOUNDATION from any liability or damages to third parties which may arise from such a failure.
7.6.8.If thenegligent or culpable act or omission on the part of the SPONSORand/or the PRINCIPAL INVESTIGATOR result in the imposition on the HOSPITAL and/or the FOUNDATION of any penalty, fine, administrative sanction, criminal conviction or any other coercive measure, theHOSPITAL and/or the FOUNDATION shall have the right to compensation from the SPONSORand/or the PRINCIPAL INVESTIGATOR, for damages caused due to their conduct, and without prejudice to exercising any other corresponding legal remedies.