Roadmap

Unit / Area involved:

• Principal Investigator (PI)
• Area of Promotion and Development of Clinical Research (PDRC, for its acronym in Catalan)
• Clinical Trials Pharmacy Unit (UFAC, for its acronym in Catalan)
• Legal Unit

General information:

Feasibilities are a series of questions that allow the sponsor/ Clinical Research Organization (CRO) to identify and select the most suitable sites to carry out a clinical trial. In order for the sponsor to obtain all the information necessary to fill in this questionnaire for clinical trials carried out at the Vall d'Hebron University Hospital (HUVH) and managed by the Vall d'Hebron Research Institute (VHIR) please contact the principal investigator (PI), the Clinical Research Promotion Area (PDRC) and the Clinical Trials Pharmacy Unit (UFAC).

Before filling in the questionnaire, the sponsor must send the confidential disclosure agreement (CDA) to the legal team to obtain the institutional signature, which will allow the promoter to release the necessary documentation so that the research team can determine the recruitment capabilities.

The research team must provide the data related to:

• The research team's general experience in clinical research.
• The experience of the Principal Investigator (PI) and the site in similar trials.
• Technological experience (IWRS, EDC, data capture in clinical trials, etc.).
• The recruitment capacity of the research team through the identification of possible patients who may fulfil the inclusion/exclusion criteria.

The Clinical Trials Pharmacy Unit must provide information on its opening hours, support staff, medication storage and temperature control, monitoring and close-out visits.

Through the Clinical Research Promotion and Development Area (PDRC), it is possible to obtain all other information about the site's infrastructure and capacity, resources and equipment, clinical history system, approval time of the site's Ethics Committee, contract negotiation and signing deadlines, as well as estimated times for the site to be activated.

Contact email:

• Principal Investigator: according to each study/service
• Feasibility Management: recerca.clinica@vhir.org
• Clinical Trials Pharmacy Unit (UFAC): farmacia.uac@vhir.org
• Legal Unit: legal@vhir.org

Contact phone:

• Principal Investigator (PI): according to each study/service
• Clinical Research Promotion Area (PDRC): +34 93 489 30 00 Ext. 2757
• Clinical Trials Pharmacy Unit (UFAC): +34 93 274 62 39

Related documents:

Below you will find documents related to this phase:

Information for pre-study and initiation visits

PDF 0.83 MB

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Unit / Area involved:

• Quality, Processes, and Document Management Unit
• Research Team

General information:

The suitability of facilities is a document requested from the sites according to current regulations (Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014), which allows the Research Ethics Committee for Medicines (CEIm) to determine that the facilities in which the clinical trial will be conducted are adequate and comply with these regulations.

The management of the suitability of the facilities is applicable to clinical trials that are carried out at the Vall d'Hebron University Hospital (HUVH) managed by the the Vall d'Hebron Research Institute (VHIR). The Sponsor/Clinical Research Organization (CRO) must fill in the eligibility form published on the VHIR website (or request it from the Document Management Unit).

Subsequently, the sponsor/CRO must contact the research team and send them the document so that the head of department can review and sign it. Lastly, the sponsor/CRO must send the document to the document management department, which will be responsible for ensuring that the document is signed by the Vall d'Hebron Research Institute Management.

Contact email:

• Document Management: gestio.documental@vhir.org
• Research team: according to each study/service

Contact phone:

• Document Management: +34 677 273 328 Ext.: 29706 
• Research Team: according to each study/service

Related documents:

Below you will find documents related to this phase:

Suitability of the facilities

DOC 0.07 MB

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Unit / Area involved:

• Legal unit

General information:

One of the requirements for conducting the clinical trial at the Vall d'Hebron University Hospital (HUVH) and for it to be managed by Vall d'Hebron Research Institute (VHIR), in accordance with Good Clinical Practice (GCP), Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014, is the agreement of the Site's Management, which must be expressed through the signing of a contract between the Sponsor/Clinical Research Organization (CRO) and the site. In this case, the contract will be signed by the principal investigator (PI) and the directors of the VHIR and the HUVH. In this case, the contract will be signed by the principal investigator (PI) and the directors of the VHIR and the HUVH.

The negotiation of the contract may begin in parallel with the approval of the regulatory bodies and will become effective when it has been approved by the Spanish Agency of Medicines and Medical Devices (AEMPS) and the favourable opinion of the Research Ethics Committee for Medicines (CEIm) is available to carry out the clinical trial at our site, in the case of drug clinical trials. Clinical trial contracts, observational studies with drugs for human use and clinical research with medical devices conducted at HUVH consist of two documents:

1. Our official contract templates containing legal clauses and provisions.
2. Our official financial memorandum template, containing the study budget and the form detailing medication-related aspects.

These documents form part of a single contract, in which the table with the breakdown of the costs of the budget, and the description of the drug, must be attached as Appendix I of each contract at the time of its signature.

Legal (contractual) and financial approval (financial report) are required to sign the contract.

A fixed fee of 1,500 euros has been established for administrative management and the management of contracts for clinical studies, observational studies with drugs for human use and clinical research with medical devices. This non-reimbursable fee (VAT not included) is reflected in the financial report of the contract and is an amount independent of the fees of the CElm and is not subject to the evaluation of the study.

The amount for the administrative management and the management of the contracts will be invoiced from the moment the contract is signed, and its collection is not conditional on the effective completion of the study or its approval by the CEIm and/or the AEMPS.

Contractual review

The following steps must be taken regarding the management of the contract and the financial report of clinical trials, observational studies with drugs for human use and clinical research with medical devices:

• Acquiring, filling in and processing the signatures of the facility suitability document (only applicable to clinical trials and clinical research with medical devices). For more information on this document, please refer to the Facility Suitability section of our roadmap.
• Acquiring and filling in the contract, addendum, and financial report forms The contract, addendum and financial report forms can be found in the Forms section of our website. If you have any queries or doubts about these models, you can contact us at:
  • Queries about contract models: legal@vhir.org
  • Queries about the financial report models and the application for subsidies for administrative and management expenses: budgetCT@vhir.org.
• Legal review of the models:
  • Legal review: Send an email to legal@vhir.org and to gestiorecercaclinica@vhir.org, with the study protocol code in the subject line, attaching the completed form and the following study documentation:
    • The facility suitability document for our center, signed by the head of the service involved in the study.
    • The study protocol and, if available, a protocol summary should be attached.
    •  The civil liability Insurance certificate (covering HUVH Centre, the VHIR Foundation, the PI and their research team).
    • Documentation providing the contractual delegation of study powers from the sponsor to the CRO, if applicable.
    • Documents certifying the favorable opinion of the CEIm and the AEMPS approval, when available.
    • Once the contract and/or completed addendum and the documents listed above are received, the legal review will commence and so the appropriate legal negotiation, if required.

Contact email:

• Legal unit: legal@vhir.org

Contact phone:

• Legal unit: +34 934 89 49 68

Related documents:

Below you will find documents related to this phase:

Clinical trial contract with medicinal products

DOCX 0.15 MB

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Unit / Area involved:

• Area of Promotion and Development of Clinical Research (PDRC, for its acronym in catalan)

General information:

In accordance with Good Clinical Practice (GCP), Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014, the financial aspects of the clinical trial must be documented in a contract between the Sponsor/Clinical Research Organization (CRO) and the principal investigator (PI)/institution.

Negotiations regarding the budget for clinical trials, observational studies and clinical research with commercial medical devices carried out by the Vall d'Hebron University Hospital (HUVH) and managed by the Vall d'Hebron Research Institute (VHIR) should be handled by the Area of Promotion and Development of Clinical Research  (PDRC) of the latter. The sponsor/CRO can download the financial memorandum template published in the related documents section below or request it by emailing the department.

The initial study budget must specify the indirect costs that the centre will apply to the direct trial costs. It must include:

• Protocol-required analysis and examinations plus any additional complementary ones.
• Changes in the duration of care for patients included in the clinical trial.
• Reimbursement of patient expenses.
• Purchase of equipment and compensation for trial subjects and researchers.
• Payment terms and conditions.
• Any other subsidiary responsibilities undertaken by the parties, in accordance with the conditions established by each centre.

A fixed fee of 1,500 euros has been established for administrative management and the management of clinical trial contracts, observational studies with drugs for human use and clinical research with medical devices (VAT not included). This non-reimbursable fee is outlined in the contract’s financial report. This amount does not include the fees of the Drug Research Ethics Committee for Medicines (CEIm) and is not conditional on the assessment of the study.

The fee for the administrative management and the managing of the contracts will be invoiced from the moment the contract is signed, and its collection is not conditional on the effective completion of the study or its approval by the CEIm and/or the Spanish Agency of Medicines and Medical Devices (AEMPS).

In exceptional circumstances, to promote and facilitate independent clinical research, the foundations may partially or fully subsidise this fee if all the following circumstances apply:

1. The sponsor is a university, hospital or public scientific organisation, not-for-profit organisation, patient association or individual researcher.
2. The researchers conduct the study, without the participation of the pharmaceutical industry or medical device companies.
3. The study does not foresee any direct or indirect payments to the researchers.
4. The design, conduct, recruitment, data collection and results communication of the research remain under the control of the sponsors who meet the specified conditions, and they own the research data.
5. There are no agreements between the promoter and third parties that allow them to use the data for regulatory uses or to generate industrial property rights, and the study does not form part of a programme to develop the marketing rights of a product.

If all these circumstances are met,* the administrative fee subsidy application form found in the downloads section below must be submitted together with the request for a contractual review of the study. This document should be sent by email to budgetCT@vhir.org so that it can be approved.

For the review of the financial report, the promoter/CRO must send an email to budgetct@vhir.org, indicating the code of the study protocol in the subject line and attach the duly completed budget. Once the financial report is received, the financial review and subsequent validation by the research team will be performed.

Contact email:

Review of the financial report:

• Vall d’Hebron Research Institute (VHIR) + Vall d'Hebron University Hospital (HUVH): Send an email to budgetct@vhir.org, indicating the study protocol code in the subject line and attaching the completed financial report (available in the Templates section).
• Vall d’Hebron Institute Oncology (VHIO) + Vall d’Hebron Research Institute (VHIR) + Vall d'Hebron University Hospital (HUVH): Send an email to ybernabe@vhio.net, indicating the study protocol code in the subject line and attaching the completed financial report (available in the Templates section). Once the financial report is received, the financial review and subsequent validation by the research team will be carried out. If the application form for the administrative and management fee grant (available in the Templates section) is submitted, it must be sent to budgetCT@vhir.org for evaluation.

Contact phone:

• Promotion and Development of Clinical Research (PDRC): +34 93 489 30 00 Ext. 2757 

Related documents:

Below you will find documents related to this phase:

Economic memory models

XLSX 0.13 MB

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Administrative expense subsidy model

DOC 0.13 MB

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Unit / Area involved:

• Regulatory authorities

General information:

In order for a clinical trial to be conducted at the Vall d'Hebron University Hospital, Good Clinical Practice requires that the Sponsor/Clinical Research Organization (or the Sponsor/CRO and the Principal Investigador if required by law) must send the clinical trial authorisation request to the regulatory authority for the necessary review, acceptance and approval (in accordance with the relevant legal requirements) to begin the study.

To be approved by the regulatory authorities, Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014 stipulate that from 31 January 2023, all new clinical trial applications must be submitted through the European CTIS system. Applications submitted through CTIS will receive an opinion that will be notified to the sponsor and will be fully valid in accordance with Regulation 536/2014 without the need for additional resolutions at the national level.

In order to include the Vall d'Hebron University Hospital (HUVH) as a participating site through the CTIS portal, please use the following identifier:

ORG-100030781 - Hospital Universitari Vall d'Hebron. With the address Passeig de la Vall d’Hebron, 119-129. Barcelona. Postcode 08035. Spain.

The sponsor/CRO must notify the centre, by means of the respective documentation, that the appropriate authorisation has been obtained from the regulatory authorities prior to conducting the site initiation visit in accordance with current legal requirements. This notification should be sent to gestiorecercaclinica@vhir.org.

Related documents:

Below you will find documents related to this phase:

Clinical Trials

Link

Unit / Area involved:

• Ethics Comittee Support Unit (USCE, for its acronym in catalan)

General information:

If the Vall d'Hebron University Hospital (HUVH) Research Ethics Committee for Medicines (CEIm) is responsible for evaluating the trial, contact the HUVH Ethics Committee Support Unit, which is responsible for evaluating clinical trials with drugs and medical devices, observational drug studies (ODS) and other research projects. It is also responsible for monitoring these studies until they are completed.

The Sponsor/Clinical Research Organization (CRO) must request the initial assessment before the start of the clinical trial and, in the case of samples, must make another request by filling in a new form at any stage of the trial.

In the event of notification of the close-out of a clinical trial, the sponsor must send the notification in digital format to the HUVH CEIm when this is the evaluating CEIm through the CTIS portal.

CEIm fees:

Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014 establish the payment of a fee for the evaluation of a clinical trial. The sponsor must pay this fee to the Spanish Agency of Medicines and Medical Devices, which is responsible for transferring the part corresponding to its evaluation to the CEIm (payment will be made through the online portal: "Payment of Fees").

For all other evaluations not involving clinical trials with drugs and their amendments, please contact the finance department regarding fees.

Contact email:

• Ethics Committee Support Unit (USCE): ceic@vhir.org

Contact phone:

• Ethics Committee Support Unit (USCE): +34 93 489 40 10

Related documents:

Below you will find documents related to this phase:

For the initial evaluation and amendments

Link

Fee CEIm

Link

Payment of fees

Link

Unit / Area involved:

• Genetically Modified Organisms (GMO) Monitoring Committee
• Legal unit

General information:

According to Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014, the covering letter of the application for initial assessment of a clinical trial must state whether the investigational medicinal product consists of one or more genetically modified organisms, in accordance with Law 9/2003, of 25 April, and Directive 2001/18/EC of the European Parliament and of the Council.

In the case that it is a genetically modified organism, this information must be notified to the Vall d'Hebron Research Institute (VHIR) Legal Department, which will begin the procedures with the GMO Monitoring Commission of the Vall d'Hebron University Hospital (HUVH). One of the functions of this committee is to determine that all clinical trials with GMOs carried out at HUVH comply with GMO regulations and are carried out under adequate biosafety conditions. In order to obtain the biosafety certificate, the sponsor/CRO must provide the Biosafety Committee with the following documentation:

• Identification of the Principal Investigator of the clinical trial at the Vall d'Hebron University Hospital.
•  Clinical Trial Protocol
• Clinical Trial Pharmacy Manual
• Authorisation of the clinical trial by the Ministry for Ecological Transition and the Demographic Challenge
• CEIm approval letter
• Approval from by the Spanish Agency of Medicines and Medical Devices (AEMPS)

The OMG Monitoring Committee will then draw up a report (the OMG certificate) indicating the authorisation of the clinical trial by the Ministry for the Ecological Transition and the Demographic Challenge, as well as a whole series of biosafety recommendations to be followed by the personnel in charge of handling the drug under investigation. This report will be delivered to the Legal Department at the Vall d'Hebron Research Institute and to the principal investigator of the clinical trial at the Vall d'Hebron University Hospital.

Contact email:

• Legal unit: legal@vhir.org
• GMO Monitoring Committee: ubprevencio@vallhebron.cat

Contact phone:

• GMO Monitoring Committee: +34 934 89 42 49 

General information:

Before activating the centre, all the steps described in this roadmap must be completed in accordance with Good Clinical Practice, Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014.

The clinical trial may begin once notification of approval from the Spanish Agency of Medicines and Medical Devices (AEMPS), the favourable opinion of the Research Ethics Committee for Medicines (CEIm) and the signature on the contract have been obtained. For clinical trials conducted at the Vall d'Hebron University Hospital (HUVH) and managed by the Vall d'Hebron Research Institute (VHIR), contract signing must be arranged with the VHIR's legal department once the parties have reached an agreement. Contracts must be signed electronically.

Unit / Area involved:

• Principal Investigator (PI)  
• Research Team  
• Clinical Trials Pharmacy Unit (UFAC for its acronym in catalan)

General information:

According to Good Clinical Practice, the Royal Decree 1090/2015, of 4 December and the Regulation (EU) no. 536/2014, in order to carry out the centre initiation visit, it will be necessary to have:

1. The favourable opinion of the evaluating Clinical Research Ethics Committee (CEIm).
2. The resolution of the authorisation of the Spanish Agency of Medicines and Medical Devices (AEMPS).
3. The signature on the contract indicating the agreement of the principal investigator (PI), the Management of the Vall d'Hebron Hospital Research Institute Foundation (VHIR) and the Management of the Vall d'Hebron University Hospital (HUVH).

The management of the site initiation visit is applicable to clinical trials conducted at the Vall d'Hebron University Hospital (HUVH) and managed by the Vall d'Hebron Research Institute (VHIR). It is essential to carry out the initiation visit for all trials before including the first patient. This visit will take place once approval has been obtained from the regulatory authorities and the contract with HUVH/VHIR has been signed.

The sponsor/CRO will contact the PI/research team and the Clinical Trials Pharmacy Unit (UFAC) directly. The sponsor/CRO must request and coordinate the centre initiation visit with all areas involved.

During the trial centre initiation visit, the sponsor must define, establish and assign all the obligations and functions related to the trial to the principal investigator and their staff, hereinafter referred to as the research team. The review of trial procedures with the participating research team must be documented in the trial initiation monitoring report.

Contact email:

• Research team: according to each study/service
• Clinical Trials Pharmacy Unit (UFAC): farmacia.uac@vhir.org

Contact phone:

• Research team: according to each study/service
• Clinical Trials Pharmacy Unit (UFAC): +34 932 74 62 39

Related documents:

Below you will find documents related to this phase:

Information for pre-study and initiation visits

PDF 0.83 MB

Download

Unit / Area involved:

• Principal Investigator (PI)
• Research Team

General information:

The principal investigator is the head of a team of investigators conducting a clinical trial at the Vall d'Hebron University Hospital (HUVH). According to Good Clinical Practice, Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014, the principal investigator (PI) must assign tasks to the members of the research team in such a way that the safety of the subjects involved in the trial and the reliability and robustness of the data obtained are not compromised.

Each person participating in the performance of a trial should be competent to carry out their tasks based on their qualifications, training and experience. The principal investigator must ensure that their collaborators are informed about the protocol, the investigational medicinal product, and their functions in the study.

The investigating team must conduct the trial in accordance with the conditions established in the protocol and in the contract signed with the promoter, the current applicable legislation and Good Clinical Practice. They will be responsible for the inclusion and follow-up of patients in accordance with the regulations and procedures necessary to ensure the integrity of the tasks carried out, of any data generated and the safety of the patient recruited in the clinical trial.

The sponsor/Clinical Research Organization (CRO) will contact the investigating team to request the respective screening, initiation, monitoring, auditing/inspection and close-out visits.

Contact email:

• Research Team: according to each study/service

Contact phone:

• Research Team: according to each study/service

Unit / Area involved:

• Clinical Trials Pharmacy Unit (UFAC, for its acronym in catalan)

General information:

According to Good Clinical Practice guidelines, the management of investigational medicinal product at the centre is the responsibility of the investigator/institution. The custody, conservation and dispensation of medicines will correspond exclusively to the Clinical Trials Unit of the Pharmacy Unit of the Vall d'Hebron University Hospital (HUVH), in accordance with Royal Decree 1/2015, of 24 July, and is applicable to all clinical trials managed by the Vall d'Hebron Research Institute (VHIR).

The sponsor is responsible for supplying the researcher/institution with the investigational medicinal product, as well as sufficient quantities of the medicinal product. Furthermore, it must ensure that the written procedures include the instructions that the researcher/institution will have to follow to handle and store the investigational medicinal product during the trial and all related documentation. The procedures must indicate the proper and safe receipt, handling, storage, dispensing, recovery of unused medication and the return of unused investigational medication to the sponsor (or alternative procedures if the promoter authorises and complies with the relevant legislation).

The sponsor must document the dispatch dates, the batch number and the dispatch method of the investigational medicinal products and trial-related materials, so as to facilitate the site's traceability of the production batch, the review of dispatch conditions and accountability (reconciliation).

The sponsor/Clinical Research Organization (CRO) will contact the Clinical Trials Unit of the Pharmacy Service to request operational information and the respective initiation, monitoring, audits and/or inspection visits.

Contact email:

• Clinical Trials Pharmacy Unit (UFAC): farmacia.uac@vhir.org

Contact phone:

• Clinical Trials Pharmacy Unit (UFAC): +34 932 74 62 39

Related documents:

Below you will find documents related to this phase:

Fundanet manual

PDF 0.5 MB

Download

Request access to Fundanet

PDF <0.01 MB

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Information for pre-study and initiation visits

PDF 0.83 MB

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Unit / Area involved:

• Clinical Trials Management Unit (UGAC)

General information:

According to Good Clinical Practice, Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014, the sponsor must adequately monitor the conduct of a clinical trial to ensure the reliability and robustness of the results and also contribute to the safety of the subjects. The monitor has a responsibility to visit the investigator before, during and after the trial, and to verify that the investigator complies with the procedures, the protocol and any approved amendments.

The Clinical Trials Management Unit (UGAC) is responsible for monitoring the commercially sponsored clinical trials conducted at the Vall d'Hebron Hospital (HUVH) and managed by the Vall d'Hebron Research Institute (VHIR). It provides support in the monitoring of clinical trials by providing spaces for monitoring and granting monitors, auditors and inspectors access to the electronic clinical records of patients included in clinical trials through the ASSCLI platform.

To request access for electronic and remote monitoring, the monitor, auditor or inspector must fill in a document with an information clause and send it to the research team, who must contact the UGAC to register them in the HUVH computer systems and assign them to the clinical trial. In addition, they will have to sign a confidentiality agreement with HUVH/VHIR.

Contact email:

• Clinical Trials Management Unit (UGAC): monitoringCT@vhir.org

Contact phone:

• Clinical Trials Management Unit (UGAC): +34 667 20 73 90

Related documents:

Below you will find documents related to this phase:

Confidentiality agreement

DOCX 0.03 MB

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Electronic monitoring information clause

PDF 1.88 MB

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Instructions Manual for electronic monitoring access

PDF 1.87 MB

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Frequent Issues Resolution Manual

PDF 1.87 MB

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Unit / Area involved:

• Clinical Trials Pharmacy Unit (UFAC, for its acronym in catalan)
• Research Team
• Clinical Trials Management Unit (UGAC, for its acronym in catalan)

General information:

For the centre to close out the clinical trials with medicinal products conducted at the Vall d'Hebron University Hospital (HUVH) and managed by the Vall d'Hebron Research Institute (VHIR), contact the research team and the Clinical Trials Pharmacy Unit (UFAC) to request a site close-out visit.

When the centre close-out visit is confirmed, the date of the site close-out must be notified to the Clinical Trials Management Unit (UGAC).

Contact email:

• Research Team: according to each study/service
• Clinical Trials Pharmacy Unit (UFAC): farmacia.uac@vhir.org
• Clinical Trials Management Unit (UGAC): monitoringCT@vhir.org

Contact phone:

• Research Team: according to each study/service
• Clinical Trials Pharmacy Unit (UFAC):  +34 932 74 62 39
• Clinical Trials Management Unit (UGAC): +34 667 20 73 90

Related documents:

Below you will find documents related to this phase:

Information for pre-study and initiation visits

PDF 0.83 MB

Download

Unit / Area involved:

• Regulatory Authorities

General information:

According to Good Clinical Practice, Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014, the end of a clinical trial consists of the last visit of the last trial subject or a later moment as defined in the protocol. In this case, the sponsor, through the EU portal, must notify each Member State involved of the completion of a clinical trial in relation to that Member State and the corresponding regulatory authorities. This notification must be made within 15 days of the completion of the clinical trial.

In the event of early termination of a clinical trial, which is the premature ending of a clinical trial for any reason before the conditions specified in the protocol are met, the Member States involved, and the corresponding regulatory authorities must be notified through the EU portal. This notification must be made without undue delay within 15 days from the date of temporary suspension or early termination and must state the reasons for this action and specify any follow-up measures.

Related documents:

For notifications of trials not transferred to CTIS (only valid until December 2024), the notifications must be managed through the AEMPS portal:

AEMPS

Link

Unit / Area involved:

• Quality, Processes, and Document Management Unit

General information:

In accordance with Good Clinical Practice, Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014, the sponsor and the investigator/centre must retain the contents of the master file in paper or digital format for at least 25 years from the end of the clinical trial, unless other acts of Union law require it to be retained for longer. However, the clinical histories of the subjects must be archived in accordance with national law. The contents of the master file must be kept in such a way that it can be made easily available to the competent authorities and that they can access it when requested.

The management of the custody of the researcher's file for clinical trials conducted at the Vall d’Hebron University Hospital (HUVH) and managed by the Vall d’Hebron Research Institute (VHIR) must be sent to a passive archive once the clinical trial has been closed, in accordance with the provisions agreed in the contract with the sponsor/Clinical Research Organization (CRO) and the legal requirements for the preservation of documentation for at least 25 years after the closure of the trial or for a longer period if so required by other applicable legal requirements.

This is managed internally by the HUVH-VHIR and the sponsor/CRO. At the link below you can download the SOP of the passive transfer, which details the location where the researcher's files will be stored.

Contact email:

• Document Management Unit; arxiuassaigs@vhir.org

Related documents:

Below you will find documents related to this phase:

Custody Standard Procedure for Closed Clinical Trials

PDF 1.96 MB

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Unit / Area involved:

• Accounting and Revenue Unit (UCI, for its acronym in catalan)

General information:

In accordance with Good Clinical Practice, Royal Decree 1090/2015, of 4 December, and Regulation (EU) 536/2014, the initial budget of the trial must specify the indirect costs to be applied by the site, as well as the extraordinary direct costs, the payment terms and any other subsidiary liability that the parties may incur, in accordance with the conditions of each centre. The financial aspects of the trial must be documented in a contract between the sponsor and the researcher/institution.

The activity related to commercial clinical trials conducted at the Vall d’Hebron University Hospital (HUVH) and managed by the Vall d’Hebron Research Institute (VHIR) will be invoiced before the centre closes. Confirmation must be obtained from the Accounting and Revenue Unit (UCI) that payment has been made for all clinical trial activities carried out by the research team. The sponsor/Clinical Research Organization (CRO) can send the request for an invoice to the Unit's email address.

Contact email:

• Accounting and Revenue Unit (UCI): facturacion@vhir.org

Related documents:

Below you will find documents related to this phase:

Invoice request model

XLSX 0.04 MB

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Unit / Area involved:

• Invoicing and Payments unit (UCI, for its acronym in catalan)

General information:

The invoicing of the activity related to the performance of any commercial clinical trial conducted at the Vall d’Hebron University Hospital (HUVH) and managed by the Vall d’Hebron Research Institute (VHIR) will be carried out through the Accounting and Revenue Unit (UCI). The sponsor/Clinical Research Organization (CRO) can send the request for an invoice to the Unit's email address.

Contact email:

• Accounting and Revenue Unit (UCI): facturacion@vhir.org

Related documents:

Below you will find documents related to this phase:

Invoice request model

XLSX 0.04 MB

Download