• 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

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

• Compilation of source documents
• Data entry in CRF's
• Resolution of queries
• Archiving of documentation
• Assistance to the monitor in remote monitoring visits.

• 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