The fundamental purpose of the Clinical Research Platform (CRP) is to create the infrastructure that will support clinical research at hospitals that can promote the population’s health and well-being, through the management of patient-based clinical research, consolidating clinical trials without commercial interest and boosting privately-promoted clinical studies in the search for excellence in both fields.
The Biodonostia HRI Clinical Research Unit forms part of the Clinical Research and Clinical Trials Units Platform at the Carlos III Health Institute, associated to the European network ECRIN (European Clinical Research Infrastructure Network). It has now renewed its membership of the new ISCIII Platform lending support to R&D&I in Biomedicine and Health Sciences – Support for clinical research.
Included in the Clinical Trials Unit’s scope of action are trials with medication, health products and those that study other therapeutic health operations. Also included are randomized clinical trials with intervention for diagnostic, preventive or service purposes.
The Donostialdea IHO services that have traditionally been more active in this area, according to number of clinical trials (2015), are:
The Clinical Research Unit is also responsible for coordinating and monitoring clinical trials and other clinical research studies, mainly of an independent nature, as well as providing support for those services that need assistance due to lack of personnel. For this purpose, the Biodonostia HRI coordinates the personnel involved in the clinical trials at our hospital, setting a common objective for Monitors, Study coordinators y Data Managers: to safeguard the rights and safety of patients taking part in a clinical trial to improve their care and quality of life as far as possible.
Through this Unit, the Institute offers advice and support in matters related to regulation and processing, economic aspects, medication management and performance of the clinical trial.
The advice and support offered includes those areas that are the promoter’s responsibility and also particularly specialised areas such as those related to documentation, filing, monitoring and follow-up of clinical trials.
The Unit is located on the ground floor of the Biodonostia HRI and is equipped with facilities to support the clinical research, a meeting room, a room for drawing samples for the patients taking part in the clinical trials, and a centralised sample collection point/laboratory.
OBJETIVES
The objectives of the Clinical Research Unit are:
To increase the volume and quality of clinical trials activity, in line with the R+D+i plan.
To promote the transfer of the results from clinical research to clinical practice, which will have an effect on the innovation and quality of healthcare.
To increase clinical trials research without commercial interest, whether promoted by Health System researchers or by external bodies.
To carry out smooth and efficient management based on optimising the time and procedures involved in setting up a clinical trial.
To foster transparency in the flow of information related to the clinical study.
To develop all clinical studies in accordance with international guidelines on ethical and scientific quality – Good Clinical Practice (GCP).
Clinical Research Platform´s Members
Clinical Trials´ Coordinators
The platform manages its processes according to the guidelines of Standard UNE-EN ISO 9001:2015, while its Quality Management System is certified by AENOR. This lends added value to the work carried out by the Platform, particularly with a view to external applicants for its services, and fosters trust regarding the extent of the Quality applied to the processing of their requests.
The Unit offers advice and support in aspects related to protocol design, DCL and Patient Information Sheet (PIS), regulatory and processing aspects, economic matters, medication management, performance of the trial and data management. The advice and support offered includes aspects that are the promoter’s responsibility and also particularly specialized aspects such as those related to documentation, filing, monitoring and follow-up of clinical trials.
Support in protocol design, DCL, PIS and implementation of different clinical studies.
Support in the Management of Documentation for assessment by the CREC and Regulatory Authorities (AEMPS [Spanish Agency for Medicines and Health Products] and Autonomous Communities).
Advice, management and support in the preparation and follow-up of administrative documentation associated with the project.
Coordination and follow-up of approvals and implementation of the Study (logistics and operations).
Advice on medication management and on performing the clinical trial (selection of CRO).
Advice on the management of contracts with suppliers.
Coordination of the study/patient.
Monitoring of study data.
Management of the Clinical Trials documentation files.
Drawing and processing of biological samples (per unit)
Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies.
The Unit’s support will depend on the resources available at any given time, and the promoters will have to guarantee the clinical trial’s viability, having suitably funded resources. Advice and support will be prioritised according to the type of promoter, the complexity of the design and the performance of the trial, the objectives, number of centres involved, and the difficulty its development entails.
Support for independent clinical trials will be given using the resources granted to the head researcher for these services in public aid schemes or through other sources, and will be formalised in a service provision agreement according to the set internal rates, which will be updated periodically. Support services provision agreements may also be formalised with private promoters, based on the corresponding external rates.
Contract management
To speed up the process of setting up a clinical trial or an observational study, we offer the chance to start processing the contract at the same time as it is assessed by the Clinical Research Ethics Committee (CREC).
The Biodonostia HRI deals with the contracts’ processing when only the Donostia University Hospital takes part from the entire Basque Country. In cases in which there is more than one centre in the Basque Country, all the processing will be centralised at the Basque Foundation for Health Innovation and Research (BIOEF).
TYPE OF CONTRACTS
There are different contract models depending on the typology of the clinical study.
For each type of contract, the documents listed in this section will be required. Said documents must be submitted by the Promoter of the study and their submission will be mandatory for signing of the contract.
Models for carrying out clinical studies in Donostialdea IHO (San Sebastian University Hospital and Primary Healthcare Centres belonging to the Donostialdea Integrated Health Organisation) and the Gipuzkoa Mental Healthcare Network contracts.
Rates valid for management of the contract at public centres in the Basque Autonomous Community for all clinical trials carried out.
A single invoice will be issued per study and the amount will vary according to the type of study and number of participating centres, according to the list of rates.
The Clinical Trials Unit, in collaboration with the Financial-Administrative Unit, will be responsible for processing all the invoices for the researchers who have requested that the BioDonostia HRI manage their funds, providing support in the following aspects:
Invoicing of the amounts corresponding to each clinical study.
Claims, wherever necessary.
Monitoring of recruited patients.
Monitoring of invoiced patients.
Answering researchers and promoters’ queries.
To make it easier for the head researchers to see the costs and income generated by the clinical studies and trials, they can use a very useful tool with web access which will make all the financial information available to them.
The Clinical Research Unit offers advice to researchers on the definition of profiles for hiring personnel or other service contracts that may be necessary to carry out the trials in question:
Site study coordinator
Data Manager.
Monitor.
Nursing staff.
Medical staff.
To do so, they can allocate the funds obtained by the clinical studies for that purpose.
The Clinical Research Unit, in collaboration with the Human Resources Unit at the Biodonostia HRI, will be responsible for advising on the selection process management. Any researchers who are interested in these processes should contact the Unit.
In relation to the Translation of knowledge to clinical practice, the Clinical Practice Guidelines (CPG) are identified, the aim of which is to transfer scientific knowledge and the improvement of care practice in order that the results may be applied with the final recipients being men and women patients and society in general.
Below is list of the principal data of the CPGs drawn up with the participation of research personnel at the Biodonostia HRI in recent years. CPGs are considered to be those published in peer-reviewed journals or drawn up on commission (by scientific companies or the administration), meaning that the CPGs drawn up by the Institution and intended for their professionals are not considered in this section.
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