RQA GLP Committee
The study director must be able to have (and show) control of the study. During the Coronovirus pandemic there have been times when the SD has not been able to be present on-site, but they should still be in touch with study staff on a regular basis. It depends on the type of study they are responsible for, but generally this would not be acceptable as they would be expected to be present for critical phases – treatment, sample collection etc. If the absence from site can be mitigated – by remote viewing etc., then in exceptional circumstance this might be acceptable, but not as a permanent situation.
Going forward the traditional SD role and the accepted requirements could change e.g. we will most likely experience a broader acceptance of virtual presence rather that physical presence, but if there is someone suitably qualified on-site then the study should be assigned to them.