UBICEC has a set of approved and updated Standard Operating Procedures (SOPs) listed below:
PEIdISBaPTUBICEC1: Protocol for resuscitation, life support and stabilisation of participants in the event of an acute emergency
PEIdISBaPTUBICEC2: Procedure to unblind treatment allocation in case of emergency
PEIdISBaPTUBICEC3: SOP for transferring trial participants/patients to other hospital services and minimum information required for staff in those services regarding participants' involvement in the clinical trial
PEIdISBaPTUBICEC4: Medication management in the clinical care setting
PEIdISBaPTUBICEC5: Agreements with other hospital services or units as required by the clinical trial protocol
PEIdISBaPTUBICEC6: Minimum staff presence requirements in the unit during a clinical trial
PEIdISBaPTUBICEC7: Management and referral of patients from other healthcare centres to the clinical trials unit, admissions and followup by the relevant service. Patients referred from other specialties and scheduled admissions from the centre itself
PEIdISBaPTUBICEC8: Waste management and unit cleaning procedure
PEIdISBaPTUBICEC9: Management and archiving of documentation generated in studies
PEIdISBaPTUBICEC10: Staff selection criteria
PEIdISBaPTUBICEC11: Onboarding guide and documentation for new staff
PEIdISBaPTUBICEC12: Communication with the participant's responsible physician
PEIdISBaPTUBICEC13: Procedure for communication and continuous contact between UBICEC and participants
PEIdISBaPTUBICEC14: Staff training in resuscitation techniques
PEIdISBaPTUBICEC15: Guide and management of IT tools
PEIdISBaPTUBICEC16: Protocol for the use, maintenance and calibration of technical equipment in the unit
PEIdISBaPTUBICEC17: Processing and shipping of biological samples
