ALWAYS, ALWAYS be sure that you base your decisions for procedural changes on your best interpretation of existing
regulatory requirements and your best judgement concerning good industry practices.

GCP Solutions guidance is intended to assist you in understanding regulatory requirements and findings meaningful and
efficient ways of meeting compliance requirements. GCP Solutions will provide you with the regulatory reference(s)
on which its recommendations are based. You can follow the GCP Solutions recommendations, modify them or do something different.
You can also get official FDA advice by submitting your good clinical practice questions to FDA at:

gcpquestions@oc.fda.gov