Advisor: Clinical Sites
One of the biggest problems I encounter is related to training and training documentation. When you look at the delegation of duties log and see what tasks have been delegated to whom the first question that you should ask yourself is “does this person have training specific to this task” and “is the training the individual received documented”. For example purposes let’s look at the delegated task of Investigational Product (IP)/Drug administration. Training comes in a variety of ways. Training could simply be from someone’s baseline education. As an example, a Registered Nurse has been well trained in the administration of medication and has passed the licensing exam to become an RN. Because of this, there is no need to have additional documentation (other than a copy of their license) related to medication administration in their training file. Yet, you take the same task and delegate it to a clinical research coordinator that is not a licensed nurse and in this case, you must have documentation in the clinical research coordinator’s training file that they have been trained to administer medication.
To simplify things I believe that there are two types of training documentation, study/trial specific training and non-study/trial specific training (CPR, fire egress, etc.). All trial specific training documentation should be kept with the trial documentation and should not be duplicated and kept in your employee’s training file. You should keep a training file for each employee where you maintain all non-trial specific training documentation such as CPR, ACLS, fire egress, etc.
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