Central Support Unit for the Coordination of Clinical Studies

Leader

Sandra Merino Ávila

Personnel

  • 35 coordinadores/as de ensayos
  • 5 enfermeros/as

Contact

sandra.merino(ELIMINAR)@salud.madrid.org

91 336 97 09

Edificio principal. Planta -2 dcha

The main mission of the Unit is to support the development of clinical studies in all the Hospital's specialties by providing management advisory services and support to the researcher, trial coordination, research nursing and other technical services. To this end, it will unify, manage and optimize all the human and material resources available in the Center for these functions and those required for their development. 

  • Equipment
    • 1 chair in preferential extractions for clinical trials, 6 recliners and 1 bed in the Medical Day Hospital.
    • Nurse's office with the necessary equipment for a complete examination (blood pressure monitor, ECG, measuring rod, scale, thermometer).
    • Monitoring room (6-8 monitors).
    • 2 rooms for test coordinators.
    • Confidential documentation archive and room for nursing kits.
    • Laboratory for processing and archiving biological samples, with refrigerated centrifuge, -20º and -80º freezers, refrigerator, probes.
    • Safety measures to ensure the proper development of the study

    .

  • Service portfolio

    SERVICE

    START-UP 

    • Confidential Disclosure Agreement (CDA)
    • Feasibility
    • Pre-study visit
    • Feasibility form
    • Facility suitability
    • Economic memorandum
    • Contract
    • Start-up visit
    • Certification and calibration of all equipment (CT, MRI, CXR, PET-CT, bone scan, centrifuge, freezer -20˚, freezer -80˚, electrocardiogram, echocardiogram, weight, sphygmomanometer, infusion pump, tonometer, OCT, retinograph, slit lamp, etc. )
    • Patient reimbursement

    COORDINATION

    Procedures of work of the coordinator:

    • Pre-screening visit or signing of pre-screening informed consentPre-screening visits
    • Pre-screening failure visit
    • Visita de fallo de pre-screening
    • Trial visit or signing of general screening informed consent 
    • Patient registration
    • Communication to Pharmacy Service
    • Tumor sample management
      • Screening failure visit
    • Block return
    • Randomization and cycle 1 Day
    • Subsequent treatment visits
    • Follow-up visit or follow-up (no disease progression)
    • Survival visit
    • Communication of SAE's, SAE's and other events of interest
    • Meetings with each unit: weekly or monthly
    • Start-up visits
    • Monitoring visit
    • Closing visit

    DATA ENTRY AND IMAGING UNIT

    • Data entry:
      • Collection of source documents.
      • Data entry in CRF's on time, in concordance between Phase I Unit and IR Phase coordinators
      • Solving queries and AE's follow-up
      • Notification of SAE's within 24 hours
      • Archiving of documentation
      • Assistance to monitor on monitoring visits
    • Imaging unit: 
      • Imaging capabilities questionnaires
      • Send test images
      • Request for image recording: CT or MRI (daily request)
      • Request for CD recording with bone scintigraphy (weekly request)
      • Request for echocardiograms recording
      • Request for PET-CT recording
      • Digitize an external CD
      • Upload images to corresponding platform according to test
    OBSERVATIONAL STUDIES AND OWN TESTS
    • Compilation of source documents
    • Data entry in CRF's
    • Resolution of queries
    • Archiving of documentation
    • Assistance to the monitor in remote monitoring visits.
    NURSING: morning and shift
    • Reception of the patient in our unit
    • Extraction of biological samples (blood and/or urine extraction)
    • Taking of constants: blood pressure, heart rate, respiratory rate, weight, height, oxygen saturation
    • Diagnostic tests: pregnancy test in urine, electrocardiograms, electrocardiographic holter, urine analysis by Combur test strip, blood extractions, capillary blood glucose.
    • Administration of subcutaneous treatments, PICC cures, reservoirs and chemotherapy infuser withdrawals.
    • Handling and shipping of samples
    • Administration of treatments
    • Preparation of future patient visits
    • Stock and HR management
    • Preselection, start and closing visits.

    BASE COST

    * Consult with coordinator for rates