Research samples

[scubindu]

As far as I know:
What training is needed and how it is documented depends to some degree on the nature of the study. Some protocols need extensive training and others may need minimal, also dependent upon the background and experience of study staff.


The regulations require that sponsors choose investigators qualified by training and experience. FDA's guidance on Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects states that, "The investigator should ensure that any individual to whom a task is delegated is qualified by education, training, and experience (and state licensure where relevant) to perform the delegated task." Please remember while the clinical investigator can delegate tasks, he/she is ultimately the one responsible for overseeing the study and protecting the subjects from harm.


The expectation is that investigators and sub-investigators and study staff will be knowledgeable about good clinical practice, including human subject protection, data integrity, recordkeeping, etc. Note that sponsors have discretion in determining what qualifications will be needed to conduct a study and may identify in the protocol a required frequency of GCP training and well as documentation of training, in which case the investigator and sub-investigators and study staff would be expected to meet that frequency of training in order to comply with the sponsors requirements.


Documentation that demonstrates what training any member of the study staff has participated in is useful to maintain as part of the relevant study files.


You may wish to consult the sponsor of your study to see if they agree that training of staff is acceptable.

[gauripuri]

Very well explained.