Clinical Study Agreement
CLINICAL TRIAL AGREEMENT
This clinical trial Agreement is made and entered into on this xx day of xx, 20xx in Barcelona, between
Fundació de Gestió Sanitària de l’Hospital de la Santa Creu i Sant Pau(hereinafter referred to as the “RESEARCHCENTER”), with VAT No. G-59.780.494, with its principal offices at Sant Antoni Maria Claret, 167, 08025 Barcelona, represented by its Chief Executive Officer Dr. Albert Salazar Soler duly authorized to execute this Agreement.
AND
XXXXXXXX (hereinafter referred to as “SPONSOR”), with VAT No.XXXXXXX, with its principal officesat XXXXXXXXXXX, represented by its XXXXXXX, Dr. /Mr. XXXXXX who isduly authorized to execute this Agreement.
,
WITNESSETH
WHEREAS, the SPONSOR desires to promote the clinical trial of the product described in the Protocol; and
WHEREAS, the RESEARCHCENTER desires to perform the clinical trial according to the terms and conditions described hereafter;
NOW, THEREFORE, in consideration of the foregoing premises contained herein, the parties hereby agree as follows:
1. SCOPE OF WORK
RESEARCHCENTER agrees to conduct the clinical trial (hereinafter referred to as “STUDY”) proposed by the SPONSORin accordance with the Protocol entitled XXXXXXXXXX, with protocol code XXXXXXXX and EudraCt. No.XXXXXXX. The PRINCIPAL INVESTIGATOR shall be responsible for conducting this clinical trial.
RESEARCHCENTERagrees to cause thePRINCIPAL INVESTIGATOR to comply with all applicable ethical laws and regulations relating to the conduct of drug clinical trials and to cooperate with the trialMonitor during the site visits or in case of inspections/audits, if any, required by Regulatory Authorities.
2. INVESTIGATIONAL product
3. CLINICAL study PLAN
4. PRINCIPAL INVESTIGATOR AND studyMONITOR
The STUDYunder this Agreement will be performed by the XXXXXXXXXXX Department. The PRINCIPAL INVESTIGATOR appointed is XXXXXXXX, ID Number XXXXXXXXXX. The Laboratory or CRO XXXXXXXXX through XXXXXXXXXXX, ID Number XXXXXXXXXXX shall be responsible of the monitoring of this STUDY.
5. STUDY DESIGN
6. NUMBER OF cases
The number of healthy patients / volunteers proposed by the SPONSOR to be enrolled in this RESEARCHCENTER is XXXX. The total number of subjects to be enrolled in the STUDYis XXXXX.
7. SAMPLE SUPPLY SYSTEM
SPONSOR shallprovide theRESEARCHCENTERat no costwith a sufficient quantity ofthe study medication to achieve the objectives of the STUDY. The Pharmacy Department of the RESEARCHCENTER will be in charge of distributing thisstudymedication. This department should be informed aboutthe storage and preservation conditions of this medication, as well as about its codification.
Moreover, the SPONSORshallensure that the products used in the STUDYhave been manufactured and/or prepared in strict accordance with the Good Manufacturing Practice guidelines (GMP), as well as labelled in accordance with allapplicable laws and regulations.
8. period of performance
SPONSOR will not initiate any activity related to the enrollment of studypatients in the RESEARCH CENTERwithout the prior written approval of the Clinical Research Ethics Committee (CEIC) and the corresponding authorization of theSpanish Agency for Drugs and Health Products (Agencia Española del Medicamento y Productos Sanitarios).
StartDate:End Date:
This Agreement shall become effective uponsignature by both parties and shall continue in full force and effect during the period of performance of the study. The termination of this Agreement will be notified to the Clinical Research Ethics Committee by the SPONSOR.
9. CONFIDENTIALITY AND PROPriETarY RIGHTS
PRINCIPAL INVESTIGATOR andtheresearchCENTERare committed to treatall documents, information, results and data related to the STUDYin a confidential manner. They will ensure that the above mentioned information will not be disclosed to third parties and will be kept in a safe place with limited access. The ResearchCenter guarantees that personnel involved in the study will act accordingly.
All data and results arising from this STUDY shall be the sole property of the SPONSOR, without affecting the statutory rights of investigators.
SPONSOR reserves the right to submit the Study outcomesto the health authorities of any country.
PRINCIPAL INVESTIGATOR must provide the SPONSORwith all test results and all data derived from the Study.
10. PUBLICATIONs
SPONSOR agrees to publish the STUDYresults, whether they are positive or negative, in public media after the study completion.
PRINCIPAL INVESTIGATOR has the right to publish the results of the STUDYin scientific journals/publications and to disseminate these results in scientific conferences only trough prior written agreementbetween both parties. PRINCIPAL INVESTIGATOR will provide theSPONSOR with a copy of such manuscript or materials for comments and revision.
SPONSOR will have thirty (30) days from the receipt of such materials to object in writing to publication or presentation. If the PRINCIPAL INVESTIGATOR has not received any comments from the SPONSOR within suchthirty (30) days period,the PRINCIPAL INVESTIGATOR may proceed to make the publication.
SPONSOR shall obtain prior written authorization from the RESEARCHCENTER,before using the name of investigator/participating institutions in scientific publications or public media, for commercial purposes or other.
11. PERSONAL DATA ProtecTION
SPONSOR of this STUDYensures that the Protocol establishes the provisions to protect personal data contained in the files of patients participating in the STUDY.
Moreover, theSPONSOR is bound to comply and to enforce the provisions stated in the Spanish constitutional law regarding Personal Data Protection (Ley Orgánica 15/1999, de 13 de Diciembre de Protección de Datos de Carácter Personal) applicable to all personal data used in the STUDY.
12. INSURANCE
SPONSOR declares to have aninsurance policy currently in force to cover any civil liability derived from the Study. This insurance policy will be maintained and up-dated during the development of the Study and will cover, at least, the provisions of the Spanish law (Real Decreto 223/2004, article 8). The details of the insurance policy are:
Insurance Company:Insurance Policy Number:
Address:City:
13. STUDY cost
Cost per complete and evaluable patient:
+ 20% Institut de Recerca:
+...... % Pharmacy Department:
Total:
(See Exhibit I: Budget breakdown).
If any patient withdrew from the TRIAL,the SPONSOR will pay the performedactivities according to the visit program included in this EXHIBIT.
14. PAYMENT CONDITIONS
Payments will be made payable to the Institut de Recerca del Hospital de la Santa Creu i San Pau,whose accounts department will issue the corresponding invoices.
15. EARLY TERMINATION of STUDY
The STUDYmay be terminatedbeforecompletion byprior written notice if any of the following conditions occur:
a)Available data suggest that it is not safe or justified to continue administering the study drug and/or comparable drug or placebo to the patients.
b)PRINCIPAL INVESTIGATOR is in breach ofany of the terms and conditions of this Agreement.
c)Observance of Protocol is inadequate or study data is repeatedly incomplete or inaccurate.
d)
d)Both parties agree to terminate this Agreement by mutual written consent.
In the event of termination of this Agreement andthe ongoing clinical studies,the RESEARCHCENTER and the SPONSOR will cooperate with each other to ensure the safety and treatment continuity of the study subjects,and to comply with all applicable laws, rules and regulations.
In any of the above mentioned cases, a report including the reasons leading toSTUDY/Agreement termination must be prepared and signed by both parties.
PRINCIPAL INVESTIGATOR shallreturn to the SPONSOR the materials and any unused study drugs provided by the SPONSOR for the performance of the Study.
PRINCIPAL INVESTIGATOR will inform, in writing, the SPONSOR and the Research Ethics Committee about any action taken towards Study termination.
In the event of early termination of the STUDY, the SPONSOR will make payment to the RESEARCHCENTERfor all services properly rendered by the RESEARCHCENTER prior to the date of termination.
16. ArbiTRATION
Any doubts or disputes which may arise due to interpretation, observance, rescission or terminationof this Agreement will be resolved if possible through arbitration with three referees. Each party will nominate a referee within 15 days of giving written notice of the doubt/dispute to the other party; the third referee will be the President of the Colegio Oficial de Médicos de Barcelona(the Barcelona College of Physicians) or a person delegated by him/her.
Arbitration will take place in Barcelona and the arbitrators will announce their binding decision for both contracting parties within three months of being named and accepting the task.
Should the dispute remain unresolved, it will be dealt with in accordance with the competence and jurisdiction of courts and tribunals of Barcelona, with express waiver of any other jurisdiction or residence.
IN WITNESS WHEREOFF, this Agreement has been executed in duplicate by the duly authorized representatives of the parties hereto as of the date and xx first written above.
Fundació de Gestió Sanitària de l’Hospital de la Santa Creu i Sant Pau
By:
______Signature______
Dr. Albert Salazar Soler
Chief Executive Officer
XXXXXXXXXXXXXXX (SPONSOR)
By:
______Signature______
Dr. XXXXXXXXXXXXXXXX
Title:......
EXHIBIT 1. CLINICAL TRIAL BUDGET BREAKDOWN