Clinical Trials Platform
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.
The platform has the following locations:
- 5th Floor Virgen de las Nieves University Hospital (Early Phases Unit)
- 5th Floor External Consultation Building Hospital Virgen de las Nieves (Consultations and extraction rooms)
- 6th Floor External Consultations Hospital Universitario Clínico San Cecilio (Consultations and extraction rooms)
La Clinical Trials Platform 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.
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The Early Phase Unit is located on the 5th floor of the General Building of the Virgen de las Nieves University Hospital in Granada. It has an area of 250 m2 and can serve up to 10 test subjects simultaneously.
It has been designed, built and equipped taking as a reference the standards set by the Andalusian Health Quality Agency (ACSA) for Early Phase Clinical Trials Units. This guarantees the involvement of the Unit in the safety of the facilities it uses, in the management of its equipment, in emergencies, in the safe control of hazardous materials and waste, as well as in the identification of occupational hazards and occupational safety, thus contributing to the provision of quality services in a safe working environment.
Access to the entire Unit is restricted through the use of an identification card. Access permissions are defined according to the personnel who will use each room. It has a direct connection with the Intensive Care Unit through two elevators.
The following areas can be defined: filing room, offices and meeting rooms, consultations, day hospital (five recliners with oxygen connection, fluid therapy and multichannel monitoring), hospitalization area (5 rooms fully equipped for a comfortable stay for the patient as well as all the electromedical, gas and serum therapy devices necessary for continuous monitoring of the subject), rest area and pharmacy area (administrative area, medicine storage room, sample processing room).
Circuits for the use of the facilities, services and operation of the EECC Unit in early phases
Guide for reserving resources for the Clinical Trials Unit in early stages
