Clinical research
The Platform for Clinical Trials fulfills a double function. The first of these is to advise researchers to conduct a non-commercial clinical trial. The second is to direct all the testing activity of the hospital center, either with direct contact with the Ethical Committee for Clinical Research (CEIC) of Granada, as well as with the monitors and data managers of commercial clinical trials. The Drug and Cytostatic Manufacturing Units are coordinated in the same way, when required or necessary for the trial.
The following units are included in this platform:
- Clinical Trials Support Unit, Virgen de las Nieves University Hospital.
- Clinical Trials Support Unit, San Cecilio Clinical University Hospital.
Since 2017, the Platform of Clinical Trials has been part of the SCReN (Spanish Clinical Research Network) Platform of Clinical Research Units and Clinical Trials. SCReN is a support structure for clinical research and, in particular, multicenter trials, made up of 31 research units (UICECs) distributed by hospital centers throughout the National Health System, which provides methodological support services , pharmacovigilance, statistics and data management, as well as in global project management, monitoring and administrative management.
Location
The platform has the following locations:
- 4th Floor Virgen de las Nieves University Hospital (early phase unit)
- 5th Floor Building External consultations Hospital Virgen de las Nieves (Consultations and extraction rooms)
- Ground Floor External Consultations Hospital Universitario San Cecilio (Consultations and extraction rooms)
On the 4th floor of the Virgen de las Nieves University Hospital are the specific facilities of the Early Phase Clinical Trials Unit. It is an area of about 116 m2
On the 5th floor of the External Consultation Building, the Clinical Trials unit has a space of 106 m2
On the ground floor of Hospital San Cecilio, this unit is located within the space designated for the Institute, with a total area of 110,7 m2
Services
La Clinical Trials Unit in early phases of the Virgen de las Nieves University Hospital fulfills a double function:
- Advising investigators facing the difficult challenge of conducting a non-commercial clinical trial. Much research is of no commercial interest, even though it is of great value to medical society. These investigations in many cases promoted by the same investigators, are now defenseless before the level of demand that a promoter must assume.
- Promote all the clinical trials activity of the center, either with direct contact with the Granada Provincial Research Ethics Committee (CEIP), or with contact with the monitors and study coordinators of commercial clinical trials. In the same way, the performance of the Processing and Cytotoxic Units is coordinated, when they are required or necessary for the test.
These functions can be summarized as:
- Encourage the development of early-stage clinical trials within the ibs.GRANADA
- Promote the development of clinical research programs and clinical trials, generated internally and carried out in a network.
- Guarantee the maximum excellence, effectiveness and efficiency in the clinical research programs generated internally or in the network.
- Collaborate with other key agents in clinical research, both with commercial and non-commercial interest.
- Support the center's researcher in the face of tangible and non-tangible problems involved in facing a clinical trial. Make the personnel trained in the unit available to him and his investigative team.
La Clinical Trials unit located on the 5th floor of the Outpatient Office Building, distributes its services based on the activities they provide:
- Medical Activity: signature of the informed consent, collection of medical history and concomitant medication, assessment of adverse effects, SAEs and / or endpoint, assessment of results of analytical studies, dispensing of study medication, patient follow-up according to the protocol.
- Nursing Activities: extraction, processing and shipment of samples, perform ECG, vital signs, anthropometric measurements.
- Coordinator activity: Data entry, including reporting AEs and SAEs, in CRF, resolution of queries, collection of study medication from the Pharmacy, coordination of documentation between laboratory and Principal Investigator, attendance at monitoring visits and / or remote monitoring, accounting of the medication returned from the study, processing and shipment of biological samples, maintenance of the stock of consumables.
Contact us
- Responsible for the Platform
Dr. Jose Cabeza Barrera
Email: jose. head.sspa@juntadeandalucia.es - Doctor: Pilar Jimenez Lopez
Email: pjimenez@ibsgranada.es
Phone: 958 895 428 - data manager: Elizabeth Garcia Penalver
Email: egarcia@ibsgranada.es
Phone: 958 895 426 - data manager: Isabel Merida Fernandez
Email: imerida@ibsgranada.es
Listening: 958 895 430 / 958 840 937 - Nurse: Mª Luz Abarca Martínez
Email: labarca@ibsgranada.es
Listening: 958 895 429 / 958 840 937 - Contract management: Juana Maria de Haro Castilian
Email: jdeharo@fibao.es
Phone: 958023136 - Invoicing: Maria Jose Jimenez Fernandez
Email: mjimenez@fibao.es
Phone: 958023298 - Responsible EECC and EEOO: Soraya Santana Martinez
Email: ssantana@fibao.es
Phone: 958023158