According to an article on Outsourcing-Pharma.com, there is a dire need for strong, clear communication between entities when transferring IRB responsibilities.
The article, entitled “Sponsor – CRO communication critical to IRB transfer; FDA,” states that all involved parties are guided by FDA to “maintain open dialogue when transferring oversight from one institutional review board (IRB) to another. Failing to do so can impact on the smooth running of a clinical trial.” However, the need to communicate is not as critical when oversight of a clinical trial is moved to an IRB within the same establishment.
To read the full article, click here. To read FDA Draft Guidance, click here.
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