Clinical trials and clinical research

Leader

Mª Ángeles Gálvez Múgica

Personnel

Dra. Mónica Aguilar Jiménez

José Daniel San Andrés (Coordinador de enfermería)

  • Equipment
    • Two hospitalization rooms (4 beds and 8 recliners)
    • Medical consultation with the necessary equipment.
    • Work office and confidential documentation file.
    • Laboratory with refrigerated centrifuge, freezers of -20º and -80º, autoclave, etc.
    • Multipurpose room
  • Noteworthy
    • Phase I Clinical Trials Unit certified by the Regional Ministry of Health of the Community of Madrid
    • Belongs to ECRIN (European Clinical Research Infrastructure Network)
  • Service portfolio

    Visit the Clinical Trials Unit (healthy volunteers and patients)

    Visit the Unit and observe nursing procedures (blood collection, ECG, etc.) and the associated laboratory technician (sample management).

    • Essay coordination and organization
    • Test preparation
    • Trial Closure
    • UCA-EC use (lingerie, light, heating, maintenance of devices)
    • Unit Income
    • Sending samples to the central laboratory
    • Sending ECG to the central laboratory
    • Study medication management

    * Rates subject to 21% withholding


    Sanitary Fungible

    • Extraction (unit)
    • ECG + Constants (unit)

    Advice on the design and methodology of the clinical trial and EPAs

    • Consultation and report preparation

    Documentation clinical trial and EPAs

    • Protocol writing support
    • Protocol adaptation
    • Translation of the protocol summary
    • Deed of consent
    • Consent Translation
    • Promoter file preparation
    • Pharmacy file preparation *
    • Research File Preparation

    Identification of participating clinical trial centers and EPAs

    • Identification, visit and selection of study centers
    • Evaluation and approval of the list of centers

    Presentation to Regulatory Authorities and CEICs clinical trials and EPAs

    • Presentation of an observational study to the AEMPS for classification
    • Preparation documentation and submission request for authorization
    • Tax payment
    • Clarification Management
    • EudraCT application and completion Annex 1 *
    • Preparation of the researcher's manual *
    • Advice to the researcher in response to clarifications

    Project management and clinical trial monitoring and EPAs

    • Development of the monitoring plan
    • Monitor Training
    • Global Project Management
    • Home-center visits
    • Home-pharmacy visits *
    • Startup visits review
    • Notice of initiation to AEMPS and CEIC
    • File Maintenance
    • Preparing and performing  researchers meeting
    • Preparation, development and reporting of periodic monitoring visits
    • Preparation, visits for sample management and pharmacy reports *
    • Annual report writing
    • Sending of annual report to CEICs, AEMPS, etc.
    • Preparation documentation amendment to the protocol
    • Send request amendment / notification to AEMPS and CEIC
    • Closing Visits
    • Closing visits to pharmacy *
    • Support for the resolution of queries and database closure
    • Center closure communication to CEIC and AEMPS
    • Preparation of the final report

    Medication, samples and complementary tests of the clinical trial

    • Stock medication control
    • Distribution of medication to the centers
    • Control and management of biological samples
    • Control and management of complementary tests

    Pharmacovigilance of the clinical trial and EPAs

    • Pharmacovigilance advice
    • Pharmacovigilance activities implementation plan
    • Update of the available documentation on the reference safety information of the medications during the study
    • Periodic reconciliation of serious adverse events (AAGs) under the pharmacovigilance procedure
    • Drafting of the annual safety report
    • Drafting of the annual safety report format DSUR *
    • Management of AAGs, Serious Adverse Reactions (RAGs) and / or SUSARs
    • Processing / sending safety reports AEMPS / CEIC / CCAA
    • Final security report writing

    * Only applicable in the case of clinical trials