PHARMACY

Main pharmacy and the back up pharmacy room are both fitted with burglar doors and windows. The room is access controlled with a biometric system for authorized personnel only. The main pharmacy has a dedicated IP/medication dispensing window. The pharmacy has lock and key clearly labelled fireproof cupboards dedicated for each study IP. The pharmacy consists of controlled continuous temperature monitoring (CTM) devices for the room as well as the freezer (-20 Freezer) and a fridge (2-8 degrees). The pharmacy team also uses a min/max manual temperature monitoring system.

The pharmacy also has a Class II Biosafety Cabinet for sterile preparation IP. There is also stopwatch and a synchronised clock for timeous preparation and IP administration. The pharmacy is also fitted with a recently serviced air conditioning unit that regulates the room temperature between 15 and 25 Degrees Celsius.

The pharmacy is always under direct supervision of a qualified pharmacist, there is a designated space for administration as well as IP preparation and a counselling room.

The Pharmacy is equipped with the following:

• A primary 2-8°C refrigerator, a primary and back up -20°C freezer.All pharmacy equipment is connected to the backup generator which automatically activates after a power failure.
• Inside the pharmacy there is also a designated printer to maintain the blind that is only connected to the pharmacist laptops
• There is an available shredder available for pharmacy staff useonly.
• Non-Investigational drugs are stored in the pharmacy display cabinets and all protocol specific pharmacy files are kept in the pharmacy in a water-proofed and lockable steel cabinets.
The pharmacy also has operational SOPs and ISF Pharmacy Binders are under lock and key in the cupboards within the pharmacy room. The site has a password-controlled 20mbps LTE Uncapped (FUP) Wi-Fi internet access for all staff members, study participants and site visitors.

The site has an automatic backup generator connected to all the equipment on site to ensure uninterrupted power supply when there is a power cut.

The site keeps its data files in an access controlled, water and fire-proof lockers, individual waterproof lockable steel cabinets for ISF files. Inside this Data room there are also smoke detectors. There is restricted access to the data room to maintain the blind and as to maintain study participant confidentiality. There is a printer and shredder that is used by all research staff in the reception area that is very close to the data filing room.