This form is to be completed six-monthly from the date of approval of the clinical trial by the South African Health Products Regulatory Authority (SAHPRA). ...
Due to the rapidly changing dynamics of the condition/disease, it has become necessary for the South African Health Products Regulatory Authority (SAHPRA) to introduce a two-weekly public health emergency (PHE) Abridged Interim Safety and Futility Monitoring Report Form for clinical trials. ...