Provide written and oral instructions on disease symptoms and signs and for the prevention of disease spread |
Study participants, research and laboratory staff may need to monitor their temperature and check for symptoms and signs of the pandemic during participation in the trial and if entering the clinical research unit/workplace |
Study participants, research and laboratory staff should frequently wash their hands with disinfectants, wear PPE (eg, laboratory garments, gloves, face masks, eye protection) and clean work surfaces and equipment with appropriate disinfectants |
Consider which visits can be conducted via remote solutions (phone check‐ups, teleconsulting and monitoring)
36
|
Provide specific instructions on clinical trial unit procedures, particularly those that generate aerosols/droplets (eg, sputum and nasal fluid collection, nasal and bronchial provocation testing). All isolations of peripheral blood mononuclear cells (PBMC) and bronchoalveolar lavages (BAL) should be performed in a BSL‐2 bench. For centrifugation steps, the use of closed beakers should be mandatory |
Provide specific instructions for the collecting, handling and processing/testing of specimens from clinical trial participants |