At times, a Sponsor may provide a site with a memo allowing the site to enroll a patient who does not meet all inclusion or exclusion criteria. Or a Sponsor may give the site pre-approval to deviate from the protocol-defined visit windows. Is this waiver enough? Would the investigative site be covered in the event of a federal audit?

I came across an interesting article which talked about sponsor communication with an IRB.  In a nutshell, it explained: Sponsor communication with IRBs has long been deemed inappropriate and since the 1980’s, sponsors having direct contact with an IRB has been frowned upon.  Per Paul Goebel, president of Paul W. Goebel Consulting, Inc., a clinical research consulting firm, and former chief of CDE’s Institutional Review Branch, “When the regs were first written, some FDA officials said the communications should go through the principal investigator to keep the sponsors from bullying the IRBs and to keep IRBs safe from undue influence by the sponsors.”