This is a very interesting question…. for a Health Care Practictioner, I really thought this was a no brainer……. Not so much!!!
With very seasoned and experienced monitors and study managers, you would get a wide array of responses, study coordinator, the physician, a sub-investigator, etc. Then you have to do a little more diggjng…….the SC, what are their qualifications, what training have they had?
What if the PI delegates this task to a non-licensed personal with sponsor based training? Is this acceptable? Simply, no.
In Canada, the provincial guidelines need to be reviewed to determine who has the ability to administer drug. For example, in Quebec, study coordinators cannot dispense study drug, only pharmacists may do so. In general a licenced practitioner, RN, MD, NP can administer study drug. Note, it is a licenced Practictioner that is permitted usually. Individuals who have certification to administer drug my be permitted, however, any limitations within the certification must be assessed prior to the delegation granted.
Study medication administration should be treated more stringently than other activities. Anyone administering study drug must be qualified by education, and sponsor training alone is not sufficient, without licensure or local permissions.
In the US, each state’s laws need to be reviewed to know who can be appropriately delegated this activity. Each state may have different rules therefore it is not a ‘one size fits all’ for the guideance. It is essential to work with your study manager and sponsor to determine who can be assigned this task.
So the bottom line is, ensure delegations are assigned properly, based on provincial or state laws.
Remember, all these reviews ensure compliance and being able to stand up to questions by inspectors.
Please let me know if you have questions or have any additional ideas.