Hello, where would you file templates for investigator surveys that need to be completed for a decision they make for each patient during the course of the study?
And any other worksheets that may be provided to the site for the documentation of some items that are elsewise at high risk to no be documented?
There is section 05.04.11 source data:
– purpose: to document and confirm source data into at the investigators site
– recommended subartifacts: source data, site level source data worksheets
It seems to be very suitable, however, it is only applicable at site level, not at study level. So where would you file the templates?