Investigators and Multi-Centre Studies

Clinical Trials - Sites and Investigators


 

The number of Investigators, Doctors and medical staff will vary according to the size of the study (number of subjects) and particularly the number of centres in a study. A Clinical Trial must have at least one Investigator and may have several Investigators


There is always a Principal Investigator. An investigator must be assigned to a centre. The same investigator can be assigned to all centres in a multi-centre study, to one centre or individually to different centres. The LabDriver system provides all options to configure the Investigator relationships to different centres in multi-centre studies.
It may be necessary to change the status of the investigator from Active to Inactive eg when they retire. The audit trail shows which investigators were active at which time and the investigator details can appear on the Lab Reports and are always stored in the audit trails.


Investigator comments and comments from clinical staff can be included and displayed on the lab reports. The comments can also be included in the electronic data exported during or at the end of the study. 


 

The access rights of each user is controlled. There are two types of control - control by the user group and permissions set on a study by study basis. This makes it possible for an investigator to add comments on one study but have no access to the data on the other study.

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