Staff and equipment
The staff at City Site consists of experienced research nurses with a solid understanding of Good Clinical Practice (GCP) and Swedish regulations such as the Biobank and Data Privacy Acts. Processes are regulated by the steering document – Standard Operating Procedures (SOP). Regular quality audits are performed by the QA Officer of A+ Science. Our research unit has access to a physician. Furthermore, we collaborate with specialists within different therapeutic areas as well as with general practitioners in primary care centers.
The below listed equipment at City Site are standard and regularly calibrated. Additional equipment is
made available if and when required.
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Sphygmomanometers
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ECG
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Blood testing equipment including cool and cold (-40°) storage. A primary blood bank has been set-up for the unit. Local analyses are performed at Karolinska University Laboratory or Medilab
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Pharmaceuticals and study drugs are stored in an ambient or refrigerated locked room. .
The Case Records System
At City Site we use the electronic case record system ErgoMed.
ErgoMed fulfills all the requirements set out by the authorities for a case record system (personal login, audit trail and back-up). In addition, since a monitor has access to patients included in the study at hand only, the case record system makes it possible to carry out Source Data Verification (SDV) directly via a computer screen.
Safety
The clinic has a fully equipped emergency bag and a defibrillator.
The Research Nurses
are trained in Cardiopulmonary resuscitation (CPR).
Archiving
All study documentation is kept and archived in locked filing cabinets. For long-term storage, documents are stored
according to customers’ request.