CONTRACT FOR CONDUCTING OBSERVATIONAL NON POST-AUTHORISATION STUDIES
Title: (complete title of study)
Protocol code: (code of protocol assigned by Sponsor)
In _____, on _____ of _____ 201_,
- By and between
(Centre)Mr/Ms(name of the legal representative of the centre), as the General Manager of the Healthcare Facility(name of the centre where the study is to take place ) and in representation of said Organisation with address at (complete address of the centre) with Post Code (add postcode)in(add the city) and TIN (add tax identification code), (hereinafter, the Centre).
(Foundation) And Ms. Susana Belaustegui Ituarte, on behalf of and in representation of the FUNDACIÓN VASCA DE INNOVACIÓN E INVESTIGACIÓN SANITARIAS (hereinafter, “BIOEF)”, with company address at Torre del BEC (Bilbao Exhibition Centre) Ronda de Azkue 1, 48902 Barakaldo (Bizkaia) and TIN G-01341353. By virtue of the powers granted by the Public Deed of Powers of Attorney executed in favour of same by said body before the Notary Public of Mondragón/Arrasate, Mr. Antonio Román de la CuestaGáldiz, on 8 September 2015 with number 710 of his notary's records.
(Sponsor) And Mr/Ms. (name of the legal representative of the Sponsor), on behalf of and in representation of (add name of company ) (hereinafter, “Sponsor”), with company address at (add complete address )and TIN (add tax identification code)with the legal capacity to sign this contract.
(Principal Investigator) And, (name of Principal Investigator), with National Identity Card number (add ID number) and with address for the purposes of notifications at the (add the service he/she belongs to) Service of the Centre. He/She acts on his/her own behalf and in his/her own representation, as the Principal Investigator, (hereinafter, also called the “Principal Investigator”).
If available, details of the body that acts in representation of the Sponsor:
(C.R.O) Mr/Ms.(name of legal representative of the company/organisation) as (add status) of the company (name of company) y and in representation of said Organisation with address at (complete address of the company) and with TIN (add tax identification number), the purpose of which is (define the role it will play in the study), (hereinafter, the “CRO”), in accordance with Annexe IV: Powers to sign on behalf of the Sponsor.
All the parties recognise each other's necessary capacity to enter into this contract.
- They Manifest and Declare
- That the Sponsor is interested in conducting an observational Non-POS study, the identification details of which are described in the heading, and whose objective and purpose are described in the following terms (add objective).
- That for his/her part, the Principal Investigator, after receiving a proposal from the Sponsor, wishes to exercise the roles that legislation currently in force attributes to him/her.
- That BIOEF is a foundation created by the General Administration of the Autonomous Community of the Basque Country as a body designed to lead and coordinate healthcare innovation and research in the Basque Health Service or Osakidetza.
- That the Centre is willing to carry out the study under the terms and conditions agreed to by the Sponsor and BIOEF.
Therefore, and in compliance with the foregoing, the parties enter into this Contract for the carrying out of an observational Non-POS study (hereinafter also called the “Contract”), based on the following.
- Terms and Conditions
- Purpose
1.1.The purpose of this Contract is to develop, on behalf of and in the name of the Sponsor, the observational Non-POS study with identified as (complete title of study)with code (add protocol code)(hereinafter, the “Study”), that shall be carried out on the premises of the Centre, under the direction and responsibility of the Principal Investigator and the management of BIOEF.
1.2.The estimated number of patients to be included shall be (add estimated number of participants) patients at this centre.
1.3.The Sponsor tasks the Principal Investigator with the recruitment procedures of the patients required for the study to be adequately conducted. The patients that shall be subjected to the study should be selected in accordance with the criteria and deadlines established in the Protocol, without prejudice to the option of the parties extending the initially agreed period.
- Terms governing implementation.
2.1.Protocol
2.1.1.The Study shall be conducted subject to the conditions and requirements of the protocol attached to this Contract as Annexe l (hereinafter the “Protocol”), respecting legislation currently in force.
2.1.2.The parties shall comply with the terms and conditions of the Protocol, including any amendments or modifications, in accordance with the provisions of Order SAS/3470/2009, of 16 December.
2.2.Commencement and duration of Study.
2.2.1.Commencement of the Study shall be determined by acquisition of classification/authorisation from the Spanish Agency of Medicines and Health Products (hereinafter, the AEMPS) if applicable, the favourable opinion of the Ethics Committee for Clinical Research (hereinafter, the CEIC)andthe agreement of the centre with the signature of this contract by all the parties.
2.2.2.The duration of the Study shall be established in the Protocol (add number of months) and shall be calculated as starting from the signing of this Contract or a favourable opinion from the CEIC.
2.2.3. The Sponsor undertakes to report the authorisation received to the AEMPS and the CEIC as soon as possible.
2.3.Modifications.
2.3.1.Any modification of the Protocol should be agreed on by the Sponsor and the Principal Investigator and should be communicated to the CEIC and the AEMPS for their approval. If said amendment is applicable to the contract, it should also receive approval from the centre and BIOEF. If said modification or amendment is regarded as important, the parties concerned shall assess if it is necessary to make changes to the Contract and/or annexes of same by means of addenda.
2.3.2.Any change of the persons participating in the study should be reported for approval to the Sponsor, the CEIC and BIOEF.
2.4.Legal ethical standards.
The Study shall be conducted subject to the regulations applicable at the time of signing this Contract and for the duration thereof, in particular the following:
2.4.1.Royal Decree 1720/2007, of 21 December, approving the implementing Regulations of Organic Law 15/1999, of 13 December, on Protection of Personal Data.
2.4.2.Law 41/2002, of 14 November, on the autonomy of the patient and rights and obligations with regard to clinical information and documentation.
2.4.3.Decree 3/2005 (Basque Country), of 11 January, creating the Ethics Committee for Clinical Research of the Autonomous Community of the Basque Country.
2.4.4.Decree 102/2005, of 26 April, regulating observational post-authorisation studies with medicines in the Basque Country.
2.4.5.Royal Decree 577/2013, of 26 June, regulating pharmacovigilance of medicines for human use.
2.4.6. Order SAS/3470/2009, of 16 December, publishing the guidelines on observational post-authorisation studies on medicines for human use.
2.4.7.It is agreed that the study shall be conducted in accordance with the Ethical Principles contained in the Helsinki Declaration in its most recent version.
2.5.Informed consent.
2.5.1.If the Study requires interviews with the subject or if it found that it is not possible to adopt a safe disassociation procedure that ensures that the information being managed does not contain personal data when using other sources of information, informed consent shall be required as per Order 9/3470/2009, of 16 December.
2.6. Access.
2.6.1.The CEIC shall have access at all times to documentation about the study, so as to monitor the studies as established in the regulatory legislation, especially informed consent of the patients that participate in same, if this is necessary.
2.6.2. The competent Health Authority and the monitors and/or auditors appointed by the Sponsor may have access to data for monitoring purposes and to verify the accuracy of the data facilitated by the Principal Investigator about the participants in the Trial and the clinical information and documentation about them that is in the Centre to verify the accuracy and reliability of same. The appointed monitors and/or auditors shall work in accordance with the provisions of art. 6 of Order SAS/34/70/2009.
2.6.3.The Principal Investigator should ensure that the monitors, auditors and CROs respect the standards of confidentiality with regard to any information about the participants of the Study.
2.6.4.The Centre shall facilitate access to said data to the CEIC and the inspectors of the competent health authorities and monitors and/or auditors.
2.7.Publication of results.
2.7.1. The Sponsor is obliged to publish the results of the study, whether they are negative or positive, and shall assume the responsibility for preparing final or partial reports, as well as for informing the relevant parties. To this end, the Principal Investigator shall give the Sponsor the clinical data obtained during the study and stipulated in the Protocol for preparing the final report with the signature of the Principal Investigator.
2.7.2. The results of the study may not be published by BIOEF, the Principal Investigator or the Centre until it has been completely terminated, and they should be authorised beforehand in a document prepared for this purpose by the Sponsor.To this end, a copy of the proposed publication should be sent to the Sponsor for review by same no later than forty five (45) days prior to issue for publication. If within said period no reply is received from the Sponsor, the proposed publication shall be regarded as approved.
2.7.3. Any lack of authorisation to publish the Results shall not impede BIOEF, the Principal Investigator or the Centre from using said Results in their professional activities.
2.7.4. If the final Results of the study (which are understood in the case of multi-centre studies as overall results) have not been published by the Sponsor within twenty four (24) months after receiving the final report, the Principal Investigator may make public said Results for professional purposes in scientific journals and publications. However, he/she should send a copy of the proposed publication to the Sponsor for review within forty five (45) days prior to publication so that the Sponsor may propose modifications that should be included when the purpose of same is to suppress commercial, technical or scientific information of a confidential nature.
2.7.5. When the results are presented in meetings or are published in scientific journals, the rights of the authors or inventors to appear as such shall be respected at all times. Mention shall also be made of the Centre as the place where the Study was carried out, and of the Sponsor as the financier of the Study.
2.7.6.The participation of the Principal Investigator or his/her collaborators as authors in multi-centre publications shall be determined in accordance with the policy of the Sponsor generally accepted standards of authorship.
2.7.7.If the study is multi-centre, publication of the Results shall not take place before the six (6) months of the first multi-centre publication.
2.8.Confidentiality and protection of data
2.8.1.The parties to this Contract undertake to treat the documents, information, results and data relating to the study as confidential and secret, ensuring restricted circulation of said information, and shall be responsible for ensuring that said obligation is complied with by all the persons that require access to same in accordance with the agreements in this Contract. The exceptions to said undertaking of confidentiality include information that: (i) the receiving party knew at the time the disclosing party when it was received; (ii) is currently or later shall become known or generally available information and where said process is not the result of an act or omission of the receiving party; (iii) disclosure is required by law or order of a court, tribunal or the administration.
2.8.2.The Centre, Principal Investigator and the monitors and/or auditors appointed by the Sponsor, shall undertake to ensure that the personal data of the participants in the study shall be treated in accordance with the provisions established in Law 15/1999, of 13 December, on protection of personal data and the regulations implementing same, Law 2/2004, of 25 February, on publicly owned personal data files and on the creation of the Basque Agency of Data Protection, as well as Law 41/2002, of 14 November, on the autonomy of the patient and rights and obligations with regard to clinical information and documentation, and special care shall be taken to ensure that any personal data of the patients that is communicated to the Sponsor shall be previously disassociated in such a way that the information that is obtained from same cannot be associated with with an identified or identifiable person.
2.8.3.BIOEF undertakes to ensure that the regulations on data protection are respected by the persons or bodies that it contracts to conduct said Study.
- Participants
3.1.Participants
3.1.1. Sponsor
Contact details:
Organisation: (add name of company)
Address: (complete address of company)
Contact person: (first name and surname)
Telephone number: (telephone number)
Electronic mail: (electronic mail address)
3.1.2. Principal Investigator:
THE PRINCIPAL INVESTIGATOR shall oversee and ensure that all the participants in the study, and especially the collaborators, shall faithfully comply with this contract and the annexes of same, and that they have been sufficiently informed of same.
3.1.3. Collaborators
3.1.3.1.The Principal Investigator shall be responsible for proposing the members of the research team and the support staff for the Study. In this regard, the Principal Investigator has proposed the following persons as collaborative researchers:
- Mr/Ms. (Complete name of the collaborator).
- Mr/Ms. (Complete name of the collaborator).
- Mr/Ms. (Complete name of the collaborator).
3.1.4.Other staff
3.1.4.1.BIOEF may contract the other professionals and material resources required to conduct the study, according to the needs indicated by the Principal Investigator, the Centre and the Sponsor.
3.1.5. BIOEF
BIOEF shall coordinate the tasks, financial and administrative management to support the Centre and the Principal Investigator in the correct implementation of the study.
3.1.6.Research Organisation
3.1.6.1.(Optional clause) To carry out the Study, the Sponsor has contracted the services of (add company name), which is a contract research organisation with business address at (add complete address )and TIN (add tax identification code). (hereinafter, the “CRO”), to carry out the following functions:
- (add function to be carried out by the CRO).
- (add function to be carried out by the CRO).
- (add function to be carried out by the CRO).
- Monitor
The Sponsor has appointed (add complete name) as monitor of the Trial (hereinafter, the “Monitor”) with National Identity Card Number (add ID number) In the event of a change of monitor, notification of same sent by the Sponsor to BIOEF shall be sufficient.
- Place of study.
- The Study should be conducted at (name of Centre and Service/Unit, where applicable).
- The Centre shall make available for the purposes of conducting the study whatever human resources are used in its daily activities.
- Financial aspects of the Study (Annexe III).
5.1.BIOEF shall invoice the Sponsor for all the costs incurred by the study, except for payment to the research team, (if there is no express indication by the Principal Investigator). The financial aspects shall be described in the financial memorandum that appears in Annexe II of the contract, as an inseparable part thereof. It shall therefore include:
5.1.1. Costs of management of the contract.
The sum of (add figure in accordance with table of rates) €+ VAT is established, payable for management of the contract, and payment shall be made against the presentation of the relevant invoice, after assessment of the study by the CEIC. One single payment shall be made for this item in the multi-centre studies. The amount of the sums shall be calculated as per the table published by BIOEF. (Table I of ANNEXE II).
5.1.2. Costs of execution of the Study.
The sum of (sum per concluded patient )€, plus tax, shall be made effective per concluded patient. (Table II of ANNEXE II).
5.2.BIOEF shall distribute the income in the following manner:
5.2.1.10% of the total of the Study shall be allocated to BIOEF to defray the expenses caused by managing the execution of same.
5.2.2.The other expenses shall be distributed in the following manner:
- 30% shall be allocated to the research centre to promote the research. (Table II of Annexe II).
- 70% shall be allocated to the research team. On the instructions of the Principal Investigator, said amount or …..% thereof , shall be paid directly to BIOEF to be reinvested in the R+D+i activities of the Researcher and/or the Research Team” (Table II of Annexe II).
- In the case of Studies of certain dimensions or others whose field makes them an area of special interest or impact for the Healthcare System of the Basque Autonomous Community, BIOEF reserves the right to adapt or adjust the distribution of billable sums.
5.3.Methods of payment
5.3.1.Calculation of the level of execution of the study for the purposes of invoicing shall be reported to the BIOEF by the Sponsor and in parallel by the Principal Investigator, so that BIOEF may issue the appropriate invoices after contrasting the data.
5.3.2.The Sponsor shall effect payment of the invoice issued by BIOEF within thirty (30) days dating from the date of issue of each invoice, in the account number given by the foundation.
5.3.3.The first payment shall be made when the contract is signed and shall correspond to the 20% maximum of the total forecast invoice, when the study is expected to last 12 months or less, and shall be 10% of the total cost when said duration is more then 12 months. In the event that performance of the study does not reach the percentage already paid, BIOEF undertakes to return the amounts collected and not used, and shall always respect the provisions in this regard.
- Obligations
- The Sponsor shall bear those obligations attributable to him in compliance with RD 577/2013 and Order SAS/3470/2009.
- The Sponsor shall also be responsible for obtaining the necessary permits from the CEIC and the AEMPS prior to commencement of the Study.
- The Principal Investigator shall conduct the Study in accordance with the provisions of RD 577/2013 and Order SAS/ 3470/2009:
- The Centre shall facilitate provision of the work of the professionals who participate in the Study, in particular that of the Principal Investigator, the Monitor and other research staff.
- BIOEF shall be responsible for the financial and administrative management of the funds for developing the Study.
- Ownership and use of Results
- The Sponsor should report the effective date of commencement to the CEIC, and to BIOEF.
- The Sponsor should inform the Ethical Committee of the end of the study within 90 days. Said period shall be reduced to 15 days in the event of early termination.
- Suspension of Study
- The Study may be suspended in the following circumstances:
- As a result of a breach of the obligations borne by the Parties in accordance with this contract, if said breach is not amended by the breaching Party within 15 days, calculated from reception of a written notification in which the complying Party demands compliance with said obligations.
- If compliance with the Protocol is deficient or the data is repeatedly inexact or incomplete.
- By mutual agreement between the contracting parties, which should be established in writing.
- The Sponsor of the study reserves the right to interrupt the inclusion of patients in any of the following circumstances:
- If the Principal Investigator does not include, without justification accepted by both parties, the agreed number of patients during the designated period.
- If the total number of patients that should be included in the study by the researchers participating therein in a multi-centre study is reached.
- In the event of early termination of the study, the Sponsor shall only pay the provisions made up to the date of the early termination.
- In the event of patients that leave for other reasons, the amount to be paid shall be calculated in proportion to the patients recruited.
- Applicable legal system and jurisdiction
9.1.The provisions of this Contract shall be regulated and interpreted in accordance with applicable legislation on studies and in particular in accordance with the provisions of RD 577/2013 and Order SAS/3740/2009.