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Information for clinical trial sponsors (ICO L'Hospitalet)

Any Sponsor interested in the participation of an ICO l'Hospitalet Investigator in a study must follow the following steps:

Preliminary information: Type of therapy, target population, Sponsor, CRO, if applicable and contact details

The investigator and the Clinical Research Unit (CRU) will analyze this information, and a preliminary contrast with the clinical trial acceptance policy will take place (you can consult the acceptance policy below).

After this previous evaluation, the investigator or CRU will return signed the confidentiality agreement sent by the sponsor or the CRO representative. Then, the trial implementation process will begin.

 

The main requirement is to send the following documents to uicico@iconcologia.net:

  • Trial protocol in Catalan, Spanish or English (whichever is presented to the Ethics Committee). Note that only a synopsis is not enough to advance in the procedure.
  • Study budget.
  • Procedures questionnaire (you can find it attached. See also the logistic assessment).

The first two documents are important because without them, the procedures cannot be completed. If you would like more information, check the start-up procedure (you will find it at the end of the section) and the assessment criteria.

As part of the internal process of evaluation of any type of clinical study, the ICO l'Hospitalet requires the Sponsor to contact its Ethics Committee (CEIm of the University Hospital of Bellvitge) to manage the document of “idoneidad de las instalaciones” (suitability of the facilities).

The management of the study contract is carried out through the IDIBELL Foundation and can be initiated from the first contact with the center, in parallel with the ethical evaluation process of the study. ICO and IDIBELL will negotiate the agreement with the sponsor in parallel to CEIm and AEMPS. A suspension clause may be included in case of completing the agreement before CEIm or AEMPS approval. In the button that appears next to this text you can see the median time of signature of the center contracts automatically updated.

The center should be mentioned by the following name: Institut Català d'Oncologia-L'Hospitalet. You must also mention the department the lead investigator belongs to: Clinical Haematology, Medical Oncology, Radiotherapy and Epidemiology.

Contacts:

The documents that have to be signed by the principal investigator for the trial have to be sent, preferably by email (uicico@iconcologia.net), to 'Gestió Econòmica de la UIC ICO L'Hospitalet' (CRU ICO L'Hospitalet Financial Management). Please send the documents in modifiable Word format so that any potential errors can be corrected.

Please see “Resources  information” to see contact details.

A systematic initial assessment of the clinical trials will be performed, which will primarily assess criteria of scientific interest, design and clinical interest. It will also consider recruitment possibilities, technical and practical difficulties, and economic interest. 

This assessment will be carried out jointly by the Principal Investigator, the Head of Department, and the Head of the Clinical Research, and will be included in an internal questionnaire.

ICO L'Hospitalet carries out an assessment of financial viability. After a study of direct and indirect costs of protocol activity, the trial is classified as:

• It fully covers the direct/ indirect costs, the work of the researchers, the nursing staff and data management.
• It covers the cost of the drug.
• It does not cover the costs derived from its application, or the drug, or the work of the researchers.

The financial assessment creates two internal documents:

1. A cost study, performed for each specific trial, based on the most accurate application of the protocol. The principles detailed in the protocol acceptance policy will generally be followed. This document provides for the following areas:
• Material resources: Total cost = usual cost + trial specific procedure costs.
• Human resources.
• CRU cost (in certain studies in which the structure supports the whole development of the study).

2. A financial and administrative budget for the study
The financial and administrative budget is the document that accounts for the amount that will be received for carrying out protocol tasks per patient or per visit, and in which details about its internal distribution to collaborating services is specified. If there is a standard line not supplied by the sponsor, it also states the repayment formula. The financial and administrative budget serves as a base for detailing the economic areas that will be included in the trial contract.

Financial details to be included in the trial contract
• Payments for carrying out protocol tasks per patient and/or visit.
• Distribution of payments among the different partner services and the hospital costs.
In the contract It will be requested that the contributions are made sequentially (quarterly, twice a year), to continually cover the costs derived from implementing the protocol.

The payment concepts accepted will be:
• Per whole patient (the breakdown is accepted in percentages).
• Per visit made (100% payment of the visit. Breakdown is not accepted in percentages).
Payments by tests method are not an approach that recognizes the role of investigator as such. Furthermore the level of thoroughness required for checking the invoices cannot be borne by the institution.

The internal distribution of the amounts is based on pre-defined collaboration agreements, which will only be modified under exceptional circumstances and always in favour of the collaboration services.
As required by Law and Good Clinical Practice standards, the sponsor will be responsible for supplying medication for the study.

Compensation for patients
Although patients cannot receive money for taking part in clinical trials, they can receive compensation for travelling to the Centre or expenses. If the sponsor wishes to include such compensation, it must be included in the contract.
Where travel compensation is to be awarded, we recommend using taxi vendors.

 

 

This duty serves to assess the technical viability and to adapt the protocol to the center’s infrastructures and procedures. This assessment is carried out using the procedures questionnaire.

External suppliers and central reviews of radiological tests:
If the protocol requires central review independent of the radiological tests or any other requirement different from the clinical practice, the sponsor must hire (contract independent of ICO L'Hospitalet) an external company to perform and send the tests for central review. The official provider is IDI DiR. However the decision about which company will be in charge of this task belongs to the sponsor considering options that will be comfortable to participants.

 

  • A systematic initial assessment of the clinical trials will be performed, which will primarily assess criteria of scientific interest, design and clinical interest, as well as the recruitment possibilities, technical and practical difficulties, and economic interest.
  • The different studies in these neoplastic pathologies will not overlap, to ensure there is no bias when recruiting patients.
  • The main quality of the study must be a fundamental interest in the performance of the researchers.
    Financial payments for the contributions made to the researcher will fall under research duties, through research accounts by individual departments, managed by IDIBELL a foundation and jointly controlled by the researcher and the institution.
  • The patient's interest will always prevail, even if there are problems of competing with scientific interest. All ethical principles will be respected, and gaining informed consent will be pursuant to internationally defined legislation.
  • No subsidized protocol should incur extra costs for the hospital.
  • Any kind of remuneration that may lead to treating more patients for extra economic gain will be avoided, as will encouraging recruitment based on rewards for the researcher.
  • The equal distribution of financial remuneration between all the services involved in implementing the protocol will be promoted.
  • It will be of great interest to boost interdepartmental and multidisciplinary collaboration, balancing the workloads and the scientific benefit expectations for each study.
  • The scientific interest of different members of staff at the institution will be encouraged, aimed at developing individual work lines.

Before the start-up visit, the CRU will assign a clinical research technician to the trial, who will be in charge of carrying out the administrative and technical tasks, which may include:

  • Data management: Filling data, queries, logbooks.
  • Protocol procedures: Record screenings, randomization procedures, restocking medication.
  • Administrative support for the head researcher: Administrative documents and amendments.

An initiation visit cannot be made unless the trial contract has been signed or is in the process of being signed. The center will return any material related to the clinical trial while it does not have the signed contract or while it is not aware that the contract is in the process of being signed.

Site clinical trial tasks invoicing:

Before issuing the invoice, the sponsor or his or her representative must contact issuing invoices section of OTRI-OSCR office from IDIBELL (please see contact details section) by email, copying in the CRU Financial and Administrative Management (see contact section), to check the terms and conditions. Financial Management will verify that:

• The terms of the invoice have been correctly detailed pursuant to the provisions of the contract.
• The information about patients (or visits) to invoice corresponds to the execution of the trial.
• The amounts invoiced adjust to the provisions of the contract.
• Once the invoice proposal has been verified and is correct, Financial Management will inform the IDIBELL invoicing party.
• Issuing invoices is the exclusive responsibility of IDIBELL, and therefore IDIBELL must not issue any invoice that has not first been checked by the CRU Financial Management.
• The termination visit will not take place until all site clinical trial tasks had been paid and charged.

CRU facilities
1. Monitoring Room (holds 10 monitors) with computers.
2. Access to Electronic Medical Records for trial monitors.
3. Freezers:
• Freezer -86º : NIRCO NU-9668-E.
• Freezer -20°. Rodiber S.A. / Model: GS-105
4. Electrocardiogram EQUIMED CP150 WIFI.
5. Centrifuge: EPPENDORF 5804 R, 230 V/5060 HZ with ROTOR S-4-72 .
6. Treatment administration: clinical trial patients are treated at the same ICO L'Hospitalet facilities. You will find information in the On-Call Care Section. ICO L'Hospitalet.

UFF1 facilities (Functional Phase I unit)
On this link you will find specific facilities information about UFF1 unit (Functional Phase I Unit)

Laboratory ranges
The ICO staff performs the sample extractions but they are processed and analysed in the Bellvitge Laboratory. By clicking on the following link, you will find documents such as the regular laboratory ranges and the certifications http://www.bellvitgehospital.cat/cat/usuaris/serveis/bioquimica/webiq.html.

Treatment administration.
Clinical trial participants are treated at the same facilities from ICO-L’Hospitalet, except for phase I clinical trials. You will find more information on

OTRI-OSRC (Clinical Research Support Office) Administration - IDIBELL

Address: Research building. Hospital de Bellvitge. Av. Feixa Llarga, s/n08907 L'Hospitalet de Llobregat
Head of Legal department:  Elisenda Batlle
Clinical Trials Contract Specialist: Laura Villagrasa Contact e-mail:  legal@idibell.cat
Issuing invoices and charging Local CREC (Clinical Research Ethics Committee) taxes: Trinidad Sánchez Contact e-mail:  facturacio@idibell.cat

Ethics Committee (Local CREC)

Address: Research building. Hospital de Bellvitge. Av. Feixa Llarga, s/n08907 L'Hospitalet de Llobregat. Barcelona. Spain. Contact: Montse Cruz, Maite Valdeolivas and Elisa Giménez. Contact e-mail: presidenciaceic@bellvitgehospital.cat

Clinical Research Unit

Address: 2rd floor, main building ICO L’Hospitalet Av. de la Granvia de l’Hospitalet, 199-203 / 08908 L’Hospitalet de Llobregat . Barcelona. Spain
Tel.: +34.93.260.73.59
Financial and Administrative Management, Clinical Trials on Therapies: Cristina Feliu - Contact e-mail: uicico@iconcologia.net

 

Update:  03.11.2011