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Information for clinical trial sponsors

To offer an ICO L'Hospitalet researcher participation in a trial, you must send the following information:

  • Types of therapy
  • Sponsor
  • CRO, if applicable
  • Target population of the therapy
  • Contact details

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

If it is possible to carry out the trial at ICO L'Hospitalet, after analysing the aforementioned information, the CRU researcher or manager will send the confidentiality agreement to the sponsor or the CRO representative. Next, the trial implementation process will begin.

 

Once the centre has manifested its desire to participate in the trial, the implementation procedure 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). You cannot advance the procedure with only a synopsis.
  • Financial report.
  • Procedures questionnaire (you can find it at the end of the 'Implementing a trial at ICO L'Hospitalet. Logistic assessment' section. 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.

Of all the documents requested by the CREC (Clinical Research Ethics Committee) of Bellvitge, there are three that are processed directly by the CRU:

  • Authorization from the head of the department the lead researcher belongs to.
  • Partnership agreements with the services involved.
  • Financial and administrative budget for the study, and an analysis of cost based on the financial report sent by the clinical trial sponsor.


The delivery time does not apply for these procedures, and the CREC of Bellvitge will assess the trial independent of the state of the internal processes.

The CREC of Bellvitge will provide the documentation that must be presented by the sponsor or representative. However it is not necessary to present the three aforementioned documents (authorization from the head of department, partnership agreements with other services, and the financial and administrative budget for the study), because this procedure is done internally.

The documents that have to be signed by the lead researcher 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.

You must mention the centre by the following name: Institut Català d'Oncologia-L'Hospitalet. You must also mention the department the lead researcher belongs to: Clinical Haematology, Medical Oncology, Radiotherapy and Oncology, etc.

 

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 included in the trial proposal scientific assessment questionnaire.

This assessment will be carried out jointly by the researcher, the head of department, and the head of the Clinical Research Unit, and will be included in a questionnaire. At times, the Management of the centre can also assess this interest.

 

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:

Cost study
A cost study will be performed for each specific trial, based on the most accurate application of the protocol possible. The principles detailed in the protocol acceptance policy will generally be followed. This document provides for the following areas:

• Material resources: real cost = usual cost - extra cost.
• Human resources.
• CRU cost (in certain studies in which the structure supports the whole development of the study).

Creation of the financial and administrative budget for the study
The financial and administrative budget is the document that accounts for the amount that will be received per patient or per visit, and details the internal distribution. 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
Fundamentally, the trial contract will have the following details:

• Payments 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 will not be accepted for tests carried out, given that it is not a method that recognizes the role of research as such, and 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 good clinical practice standards, the sponsor will be responsible for supplying medication for the study.

If there is a control line (or lines), it must be specified a priori who and how this is supplied or financed.

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 ‘bonotaxis’.

 

This assessment serves to assess the technical viability and to adapt the protocol to the centre'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, the fact that the ICO does not have its own radiological service must be taken into consideration. Radiological tests are outsourced, mainly to the IDI of the Hospital Duran i Reynals. This means that, because the ICO cannot make static images, the sponsor must hire (contract independent of ICO L'Hospitalet) an external company (IDI-Duran, CETIR, Hospital Quirón, Clínica Sagrada Família, etc.) to perform and send the tests for central review.

You will find information about the different people involved in the implementation of a trial at the foot of this document.

Once the centre's participation in the clinical trial has been agreed, the clinical trial start-up procedure of ICO L'Hospitalet must be followed (see document in the section 'Implementing a trial at ICO L'Hospitalet). Procedures and documents').

In the section 'Resources information', you will find information about the facilities and resources at the hospital for performing the tests.

 

  • 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 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, especially in cash.
  • 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 curiosity 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, query etc. collection logbooks.
  • Protocol procedures: Record screenings, randomization procedures, restocking medication.
  • Administrative support for the head researcher: Administrative documents and amendments.


Visits to begin the trial cannot be made unless the trial contract has been signed or is in the process of being signed. The centre 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.

Recruitment invoicing:
Before issuing the invoice, the sponsor or his or her representative must contact IDIBELL by email, copying in the CRU Financial and Administrative Management, 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) that you wish 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 finalising the invoice.

 

CRU facilities

Monitoring Room (holds 4 monitors)

Freezers

-80° Nuaire freezer details. Model: UN-6512E / Serial Nº: 00302234 /
Volts AC 230V 50Hz / Voltage N: serie B /Rated Input: 1065W / Amperage: 6.0A / Refrigerate R-412A (TP5R):R-508 (TP5R3) / Charge 550:245g

-20° freezer details. Rodiber SA. / Model: GS-105 / Voltage: 220V /
Power: 200W / Temperature: -30º / Frequency: 30 Hz / Refrigerate: 600a / GRS charge 59 / Serial Nº: 1005-434846489

Centrifuge: JOUAN BR4i model 0221475603 / Catalogue Nº 11175603
Passive archive

At the end of this section, you will find the calibration certificates for the different pieces of equipment at the CRU.

Treatment administration
The 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.

Laboratory ranges
The ICO will perform the 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.


Contact details

- OTRI-OSRC (Clinical Research Support Office) Administration - IDIBELL
Research building.
 Hospital de Bellvitge. Av. Feixa Llarga, s/n
08907 L'Hospitalet de Llobregat
Creation of contracts and appendixes: Pilar Roca Altimira -
 proca@idibell.cat
Issuing invoices and charging CREC (Clinical Research Ethics Committee) taxes: Trinidad Sánchez
 - tsanchez@idibell.cat

- Clinical Research and Ethics Committee
Research building. Hospital de Bellvitge. Av. Feixa Llarga, s/n
08907 L'Hospitalet de Llobregat
Contact: Inés Sánchez, Montse Cruz and Maite Valdeolivas -
 presidenciaceic@bellvitgehospital.cat

- Clinical Research Unit
Tel.: 932 607 332 / 333 / 822
Clinical Research Unit
3rd floor, main building
Catalan Institute of Oncology - L'Hospitalet
Av. de la Granvia de l'Hospitalet 199-203
08907 L'Hospitalet de Llobregat (Barcelona)
Contact:
 uicico@iconcologia.net
Financial and Administrative Management, Clinical Trials on Therapies: Cristina Feliu -
 cfeliu@iconcologia.net

 

Update:  03.11.2011