Hello everyone,

I have five CV/GCP questions:

1. For NON FDA 1572 studies, what guidance or regulations are there for checking of CVs collected at the study start? Specifically should CVs be signed and dated? How long before the start of a study is a CV valid for? Or if a CV states the correct job title for the investigator, location of the role and other aspects does it matter what the date on the CV is? Anything else? Under the FDA guidance the signing of the FDA 1572 is binding the investigator that his CV is up to date/accurate

2. If a study is a long term study, should CVs be updated and collected?

a) never, they are as collected at the start of the study
b) if there is a change in job, education or training?
c) yes because it says so in the regulations (if so where as under FDA 1572 guidance it does not need to be updated)
d) yes because the SOP says so (SOP written but no regs quoted)
e) yes every 2 years while study is ongoing from date of SIV because that seemed like a good idea?

3. Should an investigator's CV contain details of GCP training
a) contain the latest GCP course taken
b) be updated if a GCP course is taken
c) contain details of GCP training?
d) no but there should be evidence of GCP training?

4. How often should an investigator do GCP training?
a) once
b) every year
c) every 2 years
d) only if provided at investigator meeting
e) never its not required

5. If an Investigtor should be trained on GCP what should this course contain?
a) the full works of GCP and should be a proper 2 day or so course
b) at least 1 day covering investigator responsibilities and an understanding of all parts of GCP which he is not directly responsible for
c) 20 mins at an investigator meeting

For any of the above I would appreciate confirmation of the regulations or guidance which state anything on these questions.
Thanks in advance.