Clinical Trials Unit of the Hospital Pharmacy Service
The Unidad de Ensayos Clínicos del Servicio de Farmacia hospitalaria UEC-FH (Hospital Pharmacy Clinical Trials Unit, HP-CTU) provides support for conducting clinical drug trials at all stages of research. This unit carries out all support activities relating to the management, prescription, preparation-packaging and dispensing of all investigational medicinal products involved in the different arms of the clinical trial.
The objective of the UEC-FH is to collaborate with researchers from the hospital and the IIS Puerta de Hierro on all aspects related to the management and activation of samples, storage and preparation, as well as all logistical aspects required to ensure that studies are carried out in accordance with the quality and safety standards required by Good Clinical Practice (GCP) Standards.
The UEC-FH provides support activities to researchers from the Instituto de Investigación Sanitaria Puerta de Hierro-Segovia de Arana for conducting clinical drug trials at all stages of research.
- Start-up: includes the activities required by the sponsor to initiate the drug CT at the hospital. These include:
- Site pre-selection visit
- Initiation Visit: adapting the conditions for receiving and activating medication to the sponsor's requirements.
- Managing the protocol in the hospital's information systems to enable prescription and administration in the Medical Day Hospital:
- Registration, maintenance and closure of the study in all of its treatment arms.
- Support in conducting the clinical trial:
- Monitoring / accountability / temperature control
- Pharmacy CRD closure
- Audits
- Receipt, storage and activation of periodic medication shipments
- Dispensing to the PI
- Electronic completion and maintenance of information
- Disposal of surplus medication (destruction on-site; return to supplier)
- Medication management with the distributor.
- Dose titration in Phase I
- Pharmacovigilance of medicines and medical devices:
- reporting of adverse events.
UEC-FH of Hospital Pharmacy
Contact persons for Researchers, Sponsors, CROs:
- Lucia Armendariz Patier. FIB Pharmacist
- Ines Gumiel Baena: Hospital Staff Specialist (F.E.A.)
Research Pharmacy Technicians: Management and preparation of samples in clinical research:
- Rocío Vizcaya Cortés
- Pablo Rios Esteban
Head of the Pharmacy Department: Amelia Sánchez Guerrero
Contact:
- Tel: 91 191 6440
- E-mail: eecc.farmacia@idiphim.org
- Consultations to the Hospital Pharmacy by researchers from the IIS Puerta de Hierro: free of charge.
Examples:
- Suitability of facilities to meet trial requirements.
- Legislation and regulations for the labelling of investigational medicinal products and auxiliary medicinal products.
- Requirements for preparing a compounded formula for a clinical trial
- Need for manufacturing or distribution of investigational medicinal products by the Hospital Pharmacy Department.
