Bioequivalence and Bioavailability Forum

❝ You have to differentiate between functions and names (of individual staff members). For example if the PI delegates blood drawing to study nurses he/she does not have to name the individual person as long as there is a detailed job description explaining the study nurse´s tasks and responsibilities.

• have the PI sign the job description of each individual, to show that he agrees with its contents and considers the person as appropriately qualified for that job. In my experience, job descriptions are usually signed by management and/or HR, but not necessarily by the PI;
  
• maintain a list of individuals with a specific job title (e.g. study nurse). A copy should be put in the TMF;
  
• ensure (and document) that each protocol does not require any specific skills not covered by the "normal" job description.